Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-25 @ 8:34 PM
Study NCT ID:
NCT04015869
Status:
COMPLETED
Last Update Posted:
2025-08-22
First Post:
2019-04-11
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Effect of Allopregnanolone on Stress-induced Craving
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000437', 'term': 'Alcoholism'}], 'ancestors': [{'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011280', 'term': 'Pregnanolone'}], 'ancestors': [{'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Elizabeth.Ralevski@yale.edu', 'phone': '203-932-5711', 'title': 'Elizabeth Ralevski', 'phoneExt': '1-4282', 'organization': 'Yale University School of Medicine, Department of Psychiatry'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 month', 'eventGroups': [{'id': 'EG000', 'title': 'Allopregnanolone', 'description': 'Allopregnanolone infusion dose of 100nM over 175 min\n\nAllopregnanolone: neurosteroid', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo infusion\n\nPlacebos: placebo', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Alcohol Urge Questionnaire (AUQ) Pre-script', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Allopregnanolone Trauma Script', 'description': 'On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.'}, {'id': 'OG001', 'title': 'Allopregnanolone Neutral Script', 'description': 'On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.'}, {'id': 'OG002', 'title': 'Placebo Trauma Script', 'description': 'On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.'}, {'id': 'OG003', 'title': 'Placebo Neutral Script', 'description': 'On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.45', 'spread': '6.18', 'groupId': 'OG000'}, {'value': '21.51', 'spread': '5.05', 'groupId': 'OG001'}, {'value': '19.15', 'spread': '6.18', 'groupId': 'OG002'}, {'value': '26.29', 'spread': '5.05', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-Script 40 minutes before trauma/neutral script is presented', 'description': 'The Alcohol Urge Questionnaire (AUQ) is an 8-question, self-administered measure of drinking urges. Questions are in the form of a 7-point scale with participants endorsing the extent to which they agree or disagree with statements relating to desire to drink (4 items), expectation of a desired outcome from drinking (2 items), and inability to avoid drinking if alcohol was available (2 items). Total scores range from 8 (strongly disagree) to 56 (strongly agree).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All available data was utilized in the analysis using mixed models'}, {'type': 'PRIMARY', 'title': 'The State-Trait Anxiety Inventory (STAI-6) I Feel Upset - Pre-Script', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Allopregnanolone Trauma Script', 'description': 'On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.'}, {'id': 'OG001', 'title': 'Allopregnanolone Neutral Script', 'description': 'On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.'}, {'id': 'OG002', 'title': 'Placebo Trauma Script', 'description': 'On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.'}, {'id': 'OG003', 'title': 'Placebo Neutral Script', 'description': 'On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '0.26', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '0.26', 'groupId': 'OG002'}, {'value': '1.4', 'spread': '0.26', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-Script 40 minutes before trauma/neutral script is presented', 'description': 'The State Trait Anxiety Inventory (STAI-6) is a 6-item self-rated instrument used to assess anxiety state. The STAI-6 questions included: 1. "I feel calm"; 2. "I am tense"; 3. "I feel upset"; 4. "I am relaxed"; 5. "I feel content"; 6. "I am worried". Each of these questions were rated as: a) "not at all"; b) "somewhat"; c) "moderately"; d) "very much". For questions 2, 3, and 6, the scoring was a = 1, b = 2, c = 3, and d = 4.\n\nFor the other 3 questions, the scoring was a = 4, b = 3, c = 2, and d = 1. This outcome is for 3. "I feel upset" (scored individually): the scoring for "I feel upset is: a = 1, b = 2, c = 3, and d = 4 (1 not at all upset to 4 very much upset)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All available data was utilized in the analysis using mixed models'}, {'type': 'PRIMARY', 'title': 'Alcohol Urge Questionnaire (AUQ) Post-Script', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Allopregnanolone Trauma Script', 'description': 'On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.'}, {'id': 'OG001', 'title': 'Allopregnanolone Neutral Script', 'description': 'On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.'}, {'id': 'OG002', 'title': 'Placebo Trauma Script', 'description': 'On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.'}, {'id': 'OG003', 'title': 'Placebo Neutral Script', 'description': 'On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.'}], 'classes': [{'categories': [{'measurements': [{'value': '27.09', 'spread': '6.10', 'groupId': 'OG000'}, {'value': '21.50', 'spread': '7.61', 'groupId': 'OG001'}, {'value': '14.12', 'spread': '6.63', 'groupId': 'OG002'}, {'value': '24.70', 'spread': '7.61', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post-Script 5 minutes after trauma/neutral script is presented', 'description': 'The Alcohol Urge Questionnaire (AUQ) is an 8-question, self-administered measure of drinking urges. Questions are in the form of a 7-point scale with participants endorsing the extent to which they agree or disagree with statements relating to desire to drink (4 items), expectation of a desired outcome from drinking (2 items), and inability to avoid drinking if alcohol was available (2 items). Total scores range from 8 (strongly disagree) to 56 (strongly agree).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All available data was utilized in the analysis using mixed models'}, {'type': 'PRIMARY', 'title': 'Alcohol Urge Questionnaire (AUQ) Recovery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Allopregnanolone Trauma Script', 'description': 'On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.'}, {'id': 'OG001', 'title': 'Allopregnanolone Neutral Script', 'description': 'On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.'}, {'id': 'OG002', 'title': 'Placebo Trauma Script', 'description': 'On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.'}, {'id': 'OG003', 'title': 'Placebo Neutral Script', 'description': 'On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.65', 'spread': '6.56', 'groupId': 'OG000'}, {'value': '25.76', 'spread': '6.90', 'groupId': 'OG001'}, {'value': '17.03', 'spread': '7.14', 'groupId': 'OG002'}, {'value': '24.70', 'spread': '7.61', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Recovery 10 minutes after trauma/neutral script is presented', 'description': 'The Alcohol Urge Questionnaire (AUQ) is an 8-question, self-administered measure of drinking urges. Questions are in the form of a 7-point scale with participants endorsing the extent to which they agree or disagree with statements relating to desire to drink (4 items), expectation of a desired outcome from drinking (2 items), and inability to avoid drinking if alcohol was available (2 items). Total scores range from 8 (strongly disagree) to 56 (strongly agree).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All available data was utilized in the analysis using mixed models'}, {'type': 'SECONDARY', 'title': 'Biphasic Alcohol Effects Scale (BAES) Sedation Items - Pre-Script', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Allopregnanolone', 'description': 'On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.4', 'spread': '2.71', 'groupId': 'OG000'}, {'value': '6.2', 'spread': '2.71', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-Script 40 minutes before trauma/neutral script is presented', 'description': 'Biphasic Alcohol Effects Scale (BAES) Sedation items - sum of subjective responses - 0(not at all) to 10 (extremely) for 7 sedation related questions regarding effects of alcohol. Total BAES sedation subscale score: 0 (lower sedation) -70 (higher sedation) with higher numbers indicating greater sedative effects of alcohol.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis Population Description: All available data was utilized in the analysis using mixed models'}, {'type': 'SECONDARY', 'title': 'Biphasic Alcohol Effects Scale (BAES) Sedation Items', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Allopregnanolone', 'description': 'On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.6', 'spread': '3.38', 'groupId': 'OG000'}, {'value': '5.2', 'spread': '3.38', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-infusion (at 0 minutes), during infusion (approximately 20 minutes) and post-infusion (approximately 90 minutes)', 'description': 'Biphasic Alcohol Effects Scale (BAES) Sedation items - sum of subjective responses - 0(not at all) to 10 (extremely) for 7 sedation related questions regarding effects of alcohol. Total BAES sedation subscale score: 0 (lower sedation) -70 (higher sedation) with higher numbers indicating greater sedative effects of alcohol. Data presented here is mean at 90 minutes.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All available data was utilized in the analysis using mixed models'}, {'type': 'SECONDARY', 'title': 'Biphasic Alcohol Effects Scale (BAES) Sedation Items - Target Alcohol Dose (40mg%)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Allopregnanolone', 'description': 'On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.8', 'spread': '3.72', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '3.72', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Target Alcohol dose (40mg%) 90 minutes after trauma/neutral script is presented', 'description': 'Biphasic Alcohol Effects Scale (BAES) Sedation items - sum of subjective responses - 0(not at all) to 10 (extremely) for 7 sedation related questions regarding effects of alcohol. Total BAES sedation subscale score: 0 (lower sedation) -70 (higher sedation) with higher numbers indicating greater sedative effects of alcohol.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis Population Description: All available data was utilized in the analysis using mixed models'}, {'type': 'SECONDARY', 'title': 'Biphasic Alcohol Effects Scale (BAES) Sedation Items - End of Test Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Allopregnanolone', 'description': 'On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'spread': '2.54', 'groupId': 'OG000'}, {'value': '6.4', 'spread': '2.54', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of test day 150 minutes after trauma/neutral script is presented', 'description': 'Biphasic Alcohol Effects Scale (BAES) Sedation items - sum of subjective responses - 0(not at all) to 10 (extremely) for 7 sedation related questions regarding effects of alcohol. Total BAES sedation subscale score: 0 (lower sedation) -70 (higher sedation) with higher numbers indicating greater sedative effects of alcohol.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All available data was utilized in the analysis using mixed models'}, {'type': 'SECONDARY', 'title': 'Biphasic Alcohol Effects Scale (BAES) Stimulation Items - Pre-Script', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Allopregnanolone', 'description': 'On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.8', 'spread': '6.8', 'groupId': 'OG000'}, {'value': '14.2', 'spread': '6.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-Script 40 minutes before trauma/neutral script is presented', 'description': 'Biphasic Alcohol Effects Scale (BAES) Simulation items - sum of subjective responses - 0 (not at all) to 10 (extremely) for 7 sedation related questions regarding effects of alcohol. Total BAES stimulation subscale score: 0 (lower sedation) -70 (higher sedation) with higher numbers indicating greater stimulating effects of alcohol.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis Population Description: All available data was utilized in the analysis using mixed models'}, {'type': 'SECONDARY', 'title': 'Biphasic Alcohol Effects Scale (BAES) Stimulation Items', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Allopregnanolone', 'description': 'On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.4', 'spread': '8.18', 'groupId': 'OG000'}, {'value': '15.6', 'spread': '8.18', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-infusion (at 0 minutes), during infusion (approximately 20 minutes) and post-infusion (approximately 90 minutes)', 'description': 'Biphasic Alcohol Effects Scale (BAES) Simulation items - sum of subjective responses - 0 (not at all) to 10 (extremely) for 7 sedation related questions regarding effects of alcohol. Total BAES stimulation subscale score: 0 (lower sedation) -70 (higher sedation) with higher numbers indicating greater stimulating effects of alcohol. Data presented here is mean at 90 minutes.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All available data was utilized in the analysis using mixed models'}, {'type': 'SECONDARY', 'title': 'Biphasic Alcohol Effects Scale (BAES) Stimulation Items - Target Alcohol Dose (40mg%)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Allopregnanolone', 'description': 'On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.2', 'spread': '5.36', 'groupId': 'OG000'}, {'value': '31.4', 'spread': '5.36', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Target Alcohol Dose (40mg%) 90 minutes after trauma/neutral script is presented', 'description': 'Biphasic Alcohol Effects Scale (BAES) Simulation items - sum of subjective responses - 0 (not at all) to 10 (extremely) for 7 sedation related questions regarding effects of alcohol. Total BAES stimulation subscale score: 0 (lower sedation) -70 (higher sedation) with higher numbers indicating greater stimulating effects of alcohol.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis Population Description: All available data was utilized in the analysis using mixed models'}, {'type': 'SECONDARY', 'title': 'Biphasic Alcohol Effects Scale (BAES) Stimulation Items - End of Test Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Allopregnanolone', 'description': 'On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.6', 'spread': '4.18', 'groupId': 'OG000'}, {'value': '17.4', 'spread': '4.18', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of Test Day 150 minutes after trauma/neutral script is presented', 'description': 'Biphasic Alcohol Effects Scale (BAES) Simulation items - sum of subjective responses - 0 (not at all) to 10 (extremely) for 7 sedation related questions regarding effects of alcohol. Total BAES stimulation subscale score: 0 (lower sedation) -70 (higher sedation) with higher numbers indicating greater stimulating effects of alcohol.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis Population Description: All available data was utilized in the analysis using mixed models'}, {'type': 'PRIMARY', 'title': 'The State-Trait Anxiety Inventory (STAI-6) I Feel Upset - Post-Script', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Allopregnanolone Trauma Script', 'description': 'On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.'}, {'id': 'OG001', 'title': 'Allopregnanolone Neutral Script', 'description': 'On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.'}, {'id': 'OG002', 'title': 'Placebo Trauma Script', 'description': 'On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.'}, {'id': 'OG003', 'title': 'Placebo Neutral Script', 'description': 'On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '0.26', 'groupId': 'OG001'}, {'value': '1.6', 'spread': '0.26', 'groupId': 'OG002'}, {'value': '1.4', 'spread': '0.26', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post-Script 5 minutes after trauma/neutral script is presented', 'description': 'The State Trait Anxiety Inventory (STAI-6) is a 6-item self-rated instrument used to assess anxiety state. The STAI-6 questions included: 1. "I feel calm"; 2. "I am tense"; 3. "I feel upset"; 4. "I am relaxed"; 5. "I feel content"; 6. "I am worried". Each of these questions were rated as: a) "not at all"; b) "somewhat"; c) "moderately"; d) "very much". For questions 2, 3, and 6, the scoring was a = 1, b = 2, c = 3, and d = 4.\n\nFor the other 3 questions, the scoring was a = 4, b = 3, c = 2, and d = 1. This outcome is for 3. "I feel upset" (scored individually): the scoring for "I feel upset is: a = 1, b = 2, c = 3, and d = 4 (1 not at all upset to 4 very much upset)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All available data was utilized in the analysis using mixed models'}, {'type': 'PRIMARY', 'title': 'The State-Trait Anxiety Inventory (STAI-6) I Feel Upset - Recovery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Allopregnanolone Trauma Script', 'description': 'On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.'}, {'id': 'OG001', 'title': 'Allopregnanolone Neutral Script', 'description': 'On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.'}, {'id': 'OG002', 'title': 'Placebo Trauma Script', 'description': 'On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.'}, {'id': 'OG003', 'title': 'Placebo Neutral Script', 'description': 'On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '0.26', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '0.26', 'groupId': 'OG002'}, {'value': '1.2', 'spread': '0.26', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Recovery 10 minutes after trauma/neutral script is presented', 'description': 'The State Trait Anxiety Inventory (STAI-6) is a 6-item self-rated instrument used to assess anxiety state. The STAI-6 questions included: 1. "I feel calm"; 2. "I am tense"; 3. "I feel upset"; 4. "I am relaxed"; 5. "I feel content"; 6. "I am worried". Each of these questions were rated as: a) "not at all"; b) "somewhat"; c) "moderately"; d) "very much". For questions 2, 3, and 6, the scoring was a = 1, b = 2, c = 3, and d = 4.\n\nFor the other 3 questions, the scoring was a = 4, b = 3, c = 2, and d = 1. This outcome is for 3. "I feel upset" (scored individually): the scoring for "I feel upset is: a = 1, b = 2, c = 3, and d = 4 (1 not at all upset to 4 very much upset)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All available data was utilized in the analysis using mixed models'}, {'type': 'PRIMARY', 'title': 'The State-Trait Anxiety Inventory (STAI-6) I Feel Content - Pre-Script', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Allopregnanolone Trauma Script', 'description': 'On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.'}, {'id': 'OG001', 'title': 'Allopregnanolone Neutral Script', 'description': 'On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.'}, {'id': 'OG002', 'title': 'Placebo Trauma Script', 'description': 'On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.'}, {'id': 'OG003', 'title': 'Placebo Neutral Script', 'description': 'On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.16', 'spread': '0.41', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '0.39', 'groupId': 'OG001'}, {'value': '3.0', 'spread': '0.39', 'groupId': 'OG002'}, {'value': '2.2', 'spread': '0.39', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-Script 40 minutes before trauma/neutral script is presented', 'description': 'The State Trait Anxiety Inventory (STAI-6) is a 6-item self-rated instrument used to assess anxiety state. The STAI-6 questions included: 1. "I feel calm"; 2. "I am tense"; 3. "I feel upset"; 4. "I am relaxed"; 5. "I feel content"; 6. "I am worried". Each of these questions were rated as: a) "not at all"; b) "somewhat"; c) "moderately"; d) "very much". For questions 2, 3, and 6, the scoring was a = 1, b = 2, c = 3, and d = 4.\n\nFor the other 3 questions, the scoring was a = 4, b = 3, c = 2, and d = 1. This outcome is for 5. "I feel content" (scored individually): the scoring for "I feel content is: a = 4, b = 3, c = 2, and d = 1 (4 not at all content to 1 very much content)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All available data was utilized in the analysis using mixed models'}, {'type': 'PRIMARY', 'title': 'The State-Trait Anxiety Inventory (STAI-6) I Feel Content - Post-Script', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Allopregnanolone Trauma Script', 'description': 'On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.'}, {'id': 'OG001', 'title': 'Allopregnanolone Neutral Script', 'description': 'On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.'}, {'id': 'OG002', 'title': 'Placebo Trauma Script', 'description': 'On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.'}, {'id': 'OG003', 'title': 'Placebo Neutral Script', 'description': 'On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.2', 'spread': '0.39', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '0.39', 'groupId': 'OG001'}, {'value': '2.8', 'spread': '0.39', 'groupId': 'OG002'}, {'value': '2.8', 'spread': '0.39', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post-Script 5 minutes after trauma/neutral script is presented', 'description': 'The State Trait Anxiety Inventory (STAI-6) is a 6-item self-rated instrument used to assess anxiety state. The STAI-6 questions included: 1. "I feel calm"; 2. "I am tense"; 3. "I feel upset"; 4. "I am relaxed"; 5. "I feel content"; 6. "I am worried". Each of these questions were rated as: a) "not at all"; b) "somewhat"; c) "moderately"; d) "very much". For questions 2, 3, and 6, the scoring was a = 1, b = 2, c = 3, and d = 4.\n\nFor the other 3 questions, the scoring was a = 4, b = 3, c = 2, and d = 1. This outcome is for 5. "I feel content" (scored individually): the scoring for "I feel content is: a = 4, b = 3, c = 2, and d = 1 (4 not at all content to 1 very much content)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All available data was utilized in the analysis using mixed models'}, {'type': 'PRIMARY', 'title': 'The State-Trait Anxiety Inventory (STAI-6) I Feel Content - Recovery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Allopregnanolone Trauma Script', 'description': 'On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.'}, {'id': 'OG001', 'title': 'Allopregnanolone Neutral Script', 'description': 'On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.'}, {'id': 'OG002', 'title': 'Placebo Trauma Script', 'description': 'On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.'}, {'id': 'OG003', 'title': 'Placebo Neutral Script', 'description': 'On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.2', 'spread': '0.39', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '0.39', 'groupId': 'OG001'}, {'value': '2.4', 'spread': '0.39', 'groupId': 'OG002'}, {'value': '2.2', 'spread': '0.39', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Recovery10 minutes after trauma/neutral script is presented', 'description': 'The State Trait Anxiety Inventory (STAI-6) is a 6-item self-rated instrument used to assess anxiety state. The STAI-6 questions included: 1. "I feel calm"; 2. "I am tense"; 3. "I feel upset"; 4. "I am relaxed"; 5. "I feel content"; 6. "I am worried". Each of these questions were rated as: a) "not at all"; b) "somewhat"; c) "moderately"; d) "very much". For questions 2, 3, and 6, the scoring was a = 1, b = 2, c = 3, and d = 4.\n\nFor the other 3 questions, the scoring was a = 4, b = 3, c = 2, and d = 1. This outcome is for 5. "I feel content" (scored individually): the scoring for "I feel content is: a = 4, b = 3, c = 2, and d = 1 (4 not at all content to 1 very much content)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All available data was utilized in the analysis using mixed models'}, {'type': 'PRIMARY', 'title': 'The State-Trait Anxiety Inventory (STAI-6) I am Worried - Pre-Script', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Allopregnanolone Trauma Script', 'description': 'On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.'}, {'id': 'OG001', 'title': 'Allopregnanolone Neutral Script', 'description': 'On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.'}, {'id': 'OG002', 'title': 'Placebo Trauma Script', 'description': 'On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.'}, {'id': 'OG003', 'title': 'Placebo Neutral Script', 'description': 'On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '0.23', 'groupId': 'OG001'}, {'value': '1.2', 'spread': '0.23', 'groupId': 'OG002'}, {'value': '1.6', 'spread': '0.23', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-Script 40 minutes before trauma/neutral script is presented', 'description': 'The State Trait Anxiety Inventory (STAI-6) is a 6-item self-rated instrument used to assess anxiety state. The STAI-6 questions included: 1. "I feel calm"; 2. "I am tense"; 3. "I feel upset"; 4. "I am relaxed"; 5. "I feel content"; 6. "I am worried". Each of these questions were rated as: a) "not at all"; b) "somewhat"; c) "moderately"; d) "very much". For questions 2, 3, and 6, the scoring was a = 1, b = 2, c = 3, and d = 4. For the other 3 questions, the scoring was a = 4, b = 3, c = 2, and d = 1.\n\nThis outcome is for 6. "I am worried" (scored individually): the scoring for "I feel content is: a = 1, b = 2, c = 3, and d = 4 (1 not at all worried to 4 very much worried)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All available data was utilized in the analysis using mixed models'}, {'type': 'PRIMARY', 'title': 'The State-Trait Anxiety Inventory (STAI-6) I am Worried - Post-Script', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Allopregnanolone Trauma Script', 'description': 'On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.'}, {'id': 'OG001', 'title': 'Allopregnanolone Neutral Script', 'description': 'On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.'}, {'id': 'OG002', 'title': 'Placebo Trauma Script', 'description': 'On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.'}, {'id': 'OG003', 'title': 'Placebo Neutral Script', 'description': 'On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '0.23', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '0.23', 'groupId': 'OG002'}, {'value': '1.4', 'spread': '0.23', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post-Script 5 minutes after trauma/neutral script is presented', 'description': 'The State Trait Anxiety Inventory (STAI-6) is a 6-item self-rated instrument used to assess anxiety state. The STAI-6 questions included: 1. "I feel calm"; 2. "I am tense"; 3. "I feel upset"; 4. "I am relaxed"; 5. "I feel content"; 6. "I am worried". Each of these questions were rated as: a) "not at all"; b) "somewhat"; c) "moderately"; d) "very much". For questions 2, 3, and 6, the scoring was a = 1, b = 2, c = 3, and d = 4. For the other 3 questions, the scoring was a = 4, b = 3, c = 2, and d = 1.\n\nThis outcome is for 6. "I am worried" (scored individually): the scoring for "I feel content is: a = 1, b = 2, c = 3, and d = 4 (1 not at all worried to 4 very much worried)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All available data was utilized in the analysis using mixed models'}, {'type': 'PRIMARY', 'title': 'The State-Trait Anxiety Inventory (STAI-6) I am Worried - Recovery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Allopregnanolone Trauma Script', 'description': 'On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.'}, {'id': 'OG001', 'title': 'Allopregnanolone Neutral Script', 'description': 'On the test day the participant received an allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.'}, {'id': 'OG002', 'title': 'Placebo Trauma Script', 'description': 'On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.'}, {'id': 'OG003', 'title': 'Placebo Neutral Script', 'description': 'On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '0.23', 'groupId': 'OG001'}, {'value': '1.2', 'spread': '0.23', 'groupId': 'OG002'}, {'value': '1.2', 'spread': '0.23', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Recovery 10 minutes after trauma/neutral script is presented', 'description': 'The State Trait Anxiety Inventory (STAI-6) is a 6-item self-rated instrument used to assess anxiety state. The STAI-6 questions included: 1. "I feel calm"; 2. "I am tense"; 3. "I feel upset"; 4. "I am relaxed"; 5. "I feel content"; 6. "I am worried". Each of these questions were rated as: a) "not at all"; b) "somewhat"; c) "moderately"; d) "very much". For questions 2, 3, and 6, the scoring was a = 1, b = 2, c = 3, and d = 4. For the other 3 questions, the scoring was a = 4, b = 3, c = 2, and d = 1.\n\nThis outcome is for 6. "I am worried" (scored individually): the scoring for "I feel content is: a = 1, b = 2, c = 3, and d = 4 (1 not at all worried to 4 very much worried)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All available data was utilized in the analysis using mixed models'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Allopregnanolone', 'description': 'On the test day the participant received an allopregnanolone (ALLO) infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'On the test day the participant received a placebo (for allopregnanolone infusion over 175 minutes. On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant). An alcohol infusion (40mg%) begins at approximately 120 minutes into the ALLO infusion. Once target alcohol dose is reached the alcohol infusion will be clamped and continue for approximately 20 mins.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Allopregnanolone 100nM', 'description': 'Targeted dose of 100 nM of ALLO, a continuous infusion of ALLO for approximately 175 min. Sixty minutes after the start of the infusion, when ALLO levels are relatively stable, the stress induction paradigm will be introduced. Stress and neutral cues will consist of personalized 5-minute scripts created prior to testing. Measures of stress-induced craving and stress-induced anxiety will be presented before the cue (pre), immediately following the cue (post) and 10 minutes after (recovery). An alcohol infusion (40mg%) begins at approximately 120 minutes into ALLO Infusion. Once the alcohol infusion has reached the targeted dose of 40mg% the infusion is clamped for approximately 20 minutes. After 20-minute clamp both infusions will end.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo dose, a continuous infusion of placebo for approximately 175 min. Sixty minutes after the start of the infusion, when ALLO levels are relatively stable, the stress induction paradigm will be introduced. Stress and neutral cues will consist of personalized 5-minute scripts created prior to testing. Measures of stress-induced craving and stress-induced anxiety will be presented before the cue (pre), immediately following the cue (post) and 10 minutes after (recovery). An alcohol infusion (40mg%) begins at approximately 120 minutes into ALLO Infusion. Once the alcohol infusion has reached the targeted dose of 40mg% the infusion is clamped for approximately 20 minutes. After 20-minute clamp both infusions will end.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35.4', 'spread': '10.8', 'groupId': 'BG000'}, {'value': '40.8', 'spread': '7.3', 'groupId': 'BG001'}, {'value': '38.1', 'spread': '9.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-03-09', 'size': 525080, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-08-15T14:40', 'hasProtocol': True}, {'date': '2022-04-06', 'size': 324878, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-03-07T17:22', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, double blind, placebo controlled'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-05', 'studyFirstSubmitDate': '2019-04-11', 'resultsFirstSubmitDate': '2024-08-30', 'studyFirstSubmitQcDate': '2019-07-10', 'lastUpdatePostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-08-05', 'studyFirstPostDateStruct': {'date': '2019-07-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Alcohol Urge Questionnaire (AUQ) Pre-script', 'timeFrame': 'Pre-Script 40 minutes before trauma/neutral script is presented', 'description': 'The Alcohol Urge Questionnaire (AUQ) is an 8-question, self-administered measure of drinking urges. Questions are in the form of a 7-point scale with participants endorsing the extent to which they agree or disagree with statements relating to desire to drink (4 items), expectation of a desired outcome from drinking (2 items), and inability to avoid drinking if alcohol was available (2 items). Total scores range from 8 (strongly disagree) to 56 (strongly agree).'}, {'measure': 'The State-Trait Anxiety Inventory (STAI-6) I Feel Upset - Pre-Script', 'timeFrame': 'Pre-Script 40 minutes before trauma/neutral script is presented', 'description': 'The State Trait Anxiety Inventory (STAI-6) is a 6-item self-rated instrument used to assess anxiety state. The STAI-6 questions included: 1. "I feel calm"; 2. "I am tense"; 3. "I feel upset"; 4. "I am relaxed"; 5. "I feel content"; 6. "I am worried". Each of these questions were rated as: a) "not at all"; b) "somewhat"; c) "moderately"; d) "very much". For questions 2, 3, and 6, the scoring was a = 1, b = 2, c = 3, and d = 4.\n\nFor the other 3 questions, the scoring was a = 4, b = 3, c = 2, and d = 1. This outcome is for 3. "I feel upset" (scored individually): the scoring for "I feel upset is: a = 1, b = 2, c = 3, and d = 4 (1 not at all upset to 4 very much upset)'}, {'measure': 'Alcohol Urge Questionnaire (AUQ) Post-Script', 'timeFrame': 'Post-Script 5 minutes after trauma/neutral script is presented', 'description': 'The Alcohol Urge Questionnaire (AUQ) is an 8-question, self-administered measure of drinking urges. Questions are in the form of a 7-point scale with participants endorsing the extent to which they agree or disagree with statements relating to desire to drink (4 items), expectation of a desired outcome from drinking (2 items), and inability to avoid drinking if alcohol was available (2 items). Total scores range from 8 (strongly disagree) to 56 (strongly agree).'}, {'measure': 'Alcohol Urge Questionnaire (AUQ) Recovery', 'timeFrame': 'Recovery 10 minutes after trauma/neutral script is presented', 'description': 'The Alcohol Urge Questionnaire (AUQ) is an 8-question, self-administered measure of drinking urges. Questions are in the form of a 7-point scale with participants endorsing the extent to which they agree or disagree with statements relating to desire to drink (4 items), expectation of a desired outcome from drinking (2 items), and inability to avoid drinking if alcohol was available (2 items). Total scores range from 8 (strongly disagree) to 56 (strongly agree).'}, {'measure': 'The State-Trait Anxiety Inventory (STAI-6) I Feel Upset - Post-Script', 'timeFrame': 'Post-Script 5 minutes after trauma/neutral script is presented', 'description': 'The State Trait Anxiety Inventory (STAI-6) is a 6-item self-rated instrument used to assess anxiety state. The STAI-6 questions included: 1. "I feel calm"; 2. "I am tense"; 3. "I feel upset"; 4. "I am relaxed"; 5. "I feel content"; 6. "I am worried". Each of these questions were rated as: a) "not at all"; b) "somewhat"; c) "moderately"; d) "very much". For questions 2, 3, and 6, the scoring was a = 1, b = 2, c = 3, and d = 4.\n\nFor the other 3 questions, the scoring was a = 4, b = 3, c = 2, and d = 1. This outcome is for 3. "I feel upset" (scored individually): the scoring for "I feel upset is: a = 1, b = 2, c = 3, and d = 4 (1 not at all upset to 4 very much upset)'}, {'measure': 'The State-Trait Anxiety Inventory (STAI-6) I Feel Upset - Recovery', 'timeFrame': 'Recovery 10 minutes after trauma/neutral script is presented', 'description': 'The State Trait Anxiety Inventory (STAI-6) is a 6-item self-rated instrument used to assess anxiety state. The STAI-6 questions included: 1. "I feel calm"; 2. "I am tense"; 3. "I feel upset"; 4. "I am relaxed"; 5. "I feel content"; 6. "I am worried". Each of these questions were rated as: a) "not at all"; b) "somewhat"; c) "moderately"; d) "very much". For questions 2, 3, and 6, the scoring was a = 1, b = 2, c = 3, and d = 4.\n\nFor the other 3 questions, the scoring was a = 4, b = 3, c = 2, and d = 1. This outcome is for 3. "I feel upset" (scored individually): the scoring for "I feel upset is: a = 1, b = 2, c = 3, and d = 4 (1 not at all upset to 4 very much upset)'}, {'measure': 'The State-Trait Anxiety Inventory (STAI-6) I Feel Content - Pre-Script', 'timeFrame': 'Pre-Script 40 minutes before trauma/neutral script is presented', 'description': 'The State Trait Anxiety Inventory (STAI-6) is a 6-item self-rated instrument used to assess anxiety state. The STAI-6 questions included: 1. "I feel calm"; 2. "I am tense"; 3. "I feel upset"; 4. "I am relaxed"; 5. "I feel content"; 6. "I am worried". Each of these questions were rated as: a) "not at all"; b) "somewhat"; c) "moderately"; d) "very much". For questions 2, 3, and 6, the scoring was a = 1, b = 2, c = 3, and d = 4.\n\nFor the other 3 questions, the scoring was a = 4, b = 3, c = 2, and d = 1. This outcome is for 5. "I feel content" (scored individually): the scoring for "I feel content is: a = 4, b = 3, c = 2, and d = 1 (4 not at all content to 1 very much content)'}, {'measure': 'The State-Trait Anxiety Inventory (STAI-6) I Feel Content - Post-Script', 'timeFrame': 'Post-Script 5 minutes after trauma/neutral script is presented', 'description': 'The State Trait Anxiety Inventory (STAI-6) is a 6-item self-rated instrument used to assess anxiety state. The STAI-6 questions included: 1. "I feel calm"; 2. "I am tense"; 3. "I feel upset"; 4. "I am relaxed"; 5. "I feel content"; 6. "I am worried". Each of these questions were rated as: a) "not at all"; b) "somewhat"; c) "moderately"; d) "very much". For questions 2, 3, and 6, the scoring was a = 1, b = 2, c = 3, and d = 4.\n\nFor the other 3 questions, the scoring was a = 4, b = 3, c = 2, and d = 1. This outcome is for 5. "I feel content" (scored individually): the scoring for "I feel content is: a = 4, b = 3, c = 2, and d = 1 (4 not at all content to 1 very much content)'}, {'measure': 'The State-Trait Anxiety Inventory (STAI-6) I Feel Content - Recovery', 'timeFrame': 'Recovery10 minutes after trauma/neutral script is presented', 'description': 'The State Trait Anxiety Inventory (STAI-6) is a 6-item self-rated instrument used to assess anxiety state. The STAI-6 questions included: 1. "I feel calm"; 2. "I am tense"; 3. "I feel upset"; 4. "I am relaxed"; 5. "I feel content"; 6. "I am worried". Each of these questions were rated as: a) "not at all"; b) "somewhat"; c) "moderately"; d) "very much". For questions 2, 3, and 6, the scoring was a = 1, b = 2, c = 3, and d = 4.\n\nFor the other 3 questions, the scoring was a = 4, b = 3, c = 2, and d = 1. This outcome is for 5. "I feel content" (scored individually): the scoring for "I feel content is: a = 4, b = 3, c = 2, and d = 1 (4 not at all content to 1 very much content)'}, {'measure': 'The State-Trait Anxiety Inventory (STAI-6) I am Worried - Pre-Script', 'timeFrame': 'Pre-Script 40 minutes before trauma/neutral script is presented', 'description': 'The State Trait Anxiety Inventory (STAI-6) is a 6-item self-rated instrument used to assess anxiety state. The STAI-6 questions included: 1. "I feel calm"; 2. "I am tense"; 3. "I feel upset"; 4. "I am relaxed"; 5. "I feel content"; 6. "I am worried". Each of these questions were rated as: a) "not at all"; b) "somewhat"; c) "moderately"; d) "very much". For questions 2, 3, and 6, the scoring was a = 1, b = 2, c = 3, and d = 4. For the other 3 questions, the scoring was a = 4, b = 3, c = 2, and d = 1.\n\nThis outcome is for 6. "I am worried" (scored individually): the scoring for "I feel content is: a = 1, b = 2, c = 3, and d = 4 (1 not at all worried to 4 very much worried)'}, {'measure': 'The State-Trait Anxiety Inventory (STAI-6) I am Worried - Post-Script', 'timeFrame': 'Post-Script 5 minutes after trauma/neutral script is presented', 'description': 'The State Trait Anxiety Inventory (STAI-6) is a 6-item self-rated instrument used to assess anxiety state. The STAI-6 questions included: 1. "I feel calm"; 2. "I am tense"; 3. "I feel upset"; 4. "I am relaxed"; 5. "I feel content"; 6. "I am worried". Each of these questions were rated as: a) "not at all"; b) "somewhat"; c) "moderately"; d) "very much". For questions 2, 3, and 6, the scoring was a = 1, b = 2, c = 3, and d = 4. For the other 3 questions, the scoring was a = 4, b = 3, c = 2, and d = 1.\n\nThis outcome is for 6. "I am worried" (scored individually): the scoring for "I feel content is: a = 1, b = 2, c = 3, and d = 4 (1 not at all worried to 4 very much worried)'}, {'measure': 'The State-Trait Anxiety Inventory (STAI-6) I am Worried - Recovery', 'timeFrame': 'Recovery 10 minutes after trauma/neutral script is presented', 'description': 'The State Trait Anxiety Inventory (STAI-6) is a 6-item self-rated instrument used to assess anxiety state. The STAI-6 questions included: 1. "I feel calm"; 2. "I am tense"; 3. "I feel upset"; 4. "I am relaxed"; 5. "I feel content"; 6. "I am worried". Each of these questions were rated as: a) "not at all"; b) "somewhat"; c) "moderately"; d) "very much". For questions 2, 3, and 6, the scoring was a = 1, b = 2, c = 3, and d = 4. For the other 3 questions, the scoring was a = 4, b = 3, c = 2, and d = 1.\n\nThis outcome is for 6. "I am worried" (scored individually): the scoring for "I feel content is: a = 1, b = 2, c = 3, and d = 4 (1 not at all worried to 4 very much worried)'}], 'secondaryOutcomes': [{'measure': 'Biphasic Alcohol Effects Scale (BAES) Sedation Items - Pre-Script', 'timeFrame': 'Pre-Script 40 minutes before trauma/neutral script is presented', 'description': 'Biphasic Alcohol Effects Scale (BAES) Sedation items - sum of subjective responses - 0(not at all) to 10 (extremely) for 7 sedation related questions regarding effects of alcohol. Total BAES sedation subscale score: 0 (lower sedation) -70 (higher sedation) with higher numbers indicating greater sedative effects of alcohol.'}, {'measure': 'Biphasic Alcohol Effects Scale (BAES) Sedation Items', 'timeFrame': 'Pre-infusion (at 0 minutes), during infusion (approximately 20 minutes) and post-infusion (approximately 90 minutes)', 'description': 'Biphasic Alcohol Effects Scale (BAES) Sedation items - sum of subjective responses - 0(not at all) to 10 (extremely) for 7 sedation related questions regarding effects of alcohol. Total BAES sedation subscale score: 0 (lower sedation) -70 (higher sedation) with higher numbers indicating greater sedative effects of alcohol. Data presented here is mean at 90 minutes.'}, {'measure': 'Biphasic Alcohol Effects Scale (BAES) Sedation Items - Target Alcohol Dose (40mg%)', 'timeFrame': 'Target Alcohol dose (40mg%) 90 minutes after trauma/neutral script is presented', 'description': 'Biphasic Alcohol Effects Scale (BAES) Sedation items - sum of subjective responses - 0(not at all) to 10 (extremely) for 7 sedation related questions regarding effects of alcohol. Total BAES sedation subscale score: 0 (lower sedation) -70 (higher sedation) with higher numbers indicating greater sedative effects of alcohol.'}, {'measure': 'Biphasic Alcohol Effects Scale (BAES) Sedation Items - End of Test Day', 'timeFrame': 'End of test day 150 minutes after trauma/neutral script is presented', 'description': 'Biphasic Alcohol Effects Scale (BAES) Sedation items - sum of subjective responses - 0(not at all) to 10 (extremely) for 7 sedation related questions regarding effects of alcohol. Total BAES sedation subscale score: 0 (lower sedation) -70 (higher sedation) with higher numbers indicating greater sedative effects of alcohol.'}, {'measure': 'Biphasic Alcohol Effects Scale (BAES) Stimulation Items - Pre-Script', 'timeFrame': 'Pre-Script 40 minutes before trauma/neutral script is presented', 'description': 'Biphasic Alcohol Effects Scale (BAES) Simulation items - sum of subjective responses - 0 (not at all) to 10 (extremely) for 7 sedation related questions regarding effects of alcohol. Total BAES stimulation subscale score: 0 (lower sedation) -70 (higher sedation) with higher numbers indicating greater stimulating effects of alcohol.'}, {'measure': 'Biphasic Alcohol Effects Scale (BAES) Stimulation Items', 'timeFrame': 'Pre-infusion (at 0 minutes), during infusion (approximately 20 minutes) and post-infusion (approximately 90 minutes)', 'description': 'Biphasic Alcohol Effects Scale (BAES) Simulation items - sum of subjective responses - 0 (not at all) to 10 (extremely) for 7 sedation related questions regarding effects of alcohol. Total BAES stimulation subscale score: 0 (lower sedation) -70 (higher sedation) with higher numbers indicating greater stimulating effects of alcohol. Data presented here is mean at 90 minutes.'}, {'measure': 'Biphasic Alcohol Effects Scale (BAES) Stimulation Items - Target Alcohol Dose (40mg%)', 'timeFrame': 'Target Alcohol Dose (40mg%) 90 minutes after trauma/neutral script is presented', 'description': 'Biphasic Alcohol Effects Scale (BAES) Simulation items - sum of subjective responses - 0 (not at all) to 10 (extremely) for 7 sedation related questions regarding effects of alcohol. Total BAES stimulation subscale score: 0 (lower sedation) -70 (higher sedation) with higher numbers indicating greater stimulating effects of alcohol.'}, {'measure': 'Biphasic Alcohol Effects Scale (BAES) Stimulation Items - End of Test Day', 'timeFrame': 'End of Test Day 150 minutes after trauma/neutral script is presented', 'description': 'Biphasic Alcohol Effects Scale (BAES) Simulation items - sum of subjective responses - 0 (not at all) to 10 (extremely) for 7 sedation related questions regarding effects of alcohol. Total BAES stimulation subscale score: 0 (lower sedation) -70 (higher sedation) with higher numbers indicating greater stimulating effects of alcohol.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alcohol Use Disorder']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to determine whether intravenous infusion of allopregnanolone (ALLO) attenuates stress-induced craving and stress-induced anxiety in a clinical laboratory setting. The secondary objective of this project is to characterize the behavioral effects of ALLO in heavy drinkers.', 'detailedDescription': 'This is a double-blind, placebo-controlled study that will randomize heavy "at risk" drinkers to 2 groups: targeted dose of 100 nM of ALLO or placebo. Participants will receive a continuous infusion of ALLO (or placebo) for approximately 175 min. Sixty minutes after the start of the infusion, when ALLO levels are relatively stable, the stress induction paradigm will be introduced. Participants will be presented with a stress cue and a neutral cue in random order. Stress and neutral cues will consist of personalized 5-minute scripts created prior to testing. Measures of stress-induced craving and stress-induced anxiety will be presented before the cue (pre), immediately following the cue (post) and 10 minutes after (recovery). An alcohol infusion (40mg%) begins at approximately 120 minutes into ALLO Infusion. Once the alcohol infusion has reached the targeted dose of 40mg% the infusion is clamped for approximately 20 minutes. The study outcomes will include measures of stress-induced craving and stress-induced anxiety as well as measures of subjective mood effects, cognitive performance, and motor coordination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-treatment seeking individuals with current Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) alcohol use disorder (AUD)\n* No current substance use disorder (except tobacco, alcohol, and marijuana)\n* No current medical problems and normal electrocardiogram (ECG)\n* For women, not pregnant as determined by pregnancy screening, not breast feeding.\n\nExclusion Criteria:\n\n* Current major psychiatric illnesses including mood, psychotic, or anxiety disorders\n* History of major medical illnesses; including liver diseases, heart disease, chronic pain or other medical conditions that the physician investigator deems contraindicated for the subject to be in the study\n* Liver function tests (ALT or AST) greater than 3 times normal\n* weight \\>120kg\n* renal impairment\n* patients on the following medications: a) medications for alcoholism (e.g. naltrexone, disulfiram, topiramate, acamprosate); b) psychotropic medications that promote sedation (please note patients on psychotropic medications for current psychiatric conditions will also be excluded); and c) patients currently taking antibiotics or antifungals'}, 'identificationModule': {'nctId': 'NCT04015869', 'briefTitle': 'Effect of Allopregnanolone on Stress-induced Craving', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Effect of Allopregnanolone on Stress-induced Craving', 'orgStudyIdInfo': {'id': '2000021601'}, 'secondaryIdInfos': [{'id': '1R21AA024917-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R21AA024917-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'allopregnanolone', 'description': 'Allopregnanolone infusion dose of 100nM over 175 min', 'interventionNames': ['Drug: Allopregnanolone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'Placebo infusion', 'interventionNames': ['Drug: Placebos']}], 'interventions': [{'name': 'Allopregnanolone', 'type': 'DRUG', 'description': 'neurosteroid', 'armGroupLabels': ['allopregnanolone']}, {'name': 'Placebos', 'type': 'DRUG', 'description': 'placebo', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06516', 'city': 'West Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'VA Connecticut Healtcase System', 'geoPoint': {'lat': 41.27065, 'lon': -72.94705}}], 'overallOfficials': [{'name': 'Elizabeth Ralevski, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Scientist', 'investigatorFullName': 'Elizabeth Ralevski', 'investigatorAffiliation': 'Yale University'}}}}