Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2025-12-25 @ 9:51 PM
Study NCT ID:
NCT04854551
Status:
COMPLETED
Last Update Posted:
2023-11-28
First Post:
2021-04-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Opioid Modulation and Neural Reward Activation in Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-06-09', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000428', 'term': 'Alcohol Drinking'}], 'ancestors': [{'id': 'D004327', 'term': 'Drinking Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009271', 'term': 'Naltrexone'}], 'ancestors': [{'id': 'D009270', 'term': 'Naloxone'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'joshua.gowin@cuanschutz.edu', 'phone': '3037243769', 'title': 'Joshua Gowin', 'organization': 'University of Colorado Anschutz Medical Campus'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 week', 'description': 'Self report', 'eventGroups': [{'id': 'EG000', 'title': 'Naltrexone', 'description': 'Participants who received Naltrexone capsules for 5 days (25mg for days 1 and 2, then 50mg for days 3, 4, and 5) before either the first or second scanning session.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants who received Placebo capsules before either the first or second scanning session.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Brain Activation to Reward Between Placebo and Active Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Naltrexone', 'description': 'Participants who received Naltrexone capsules for 5 days (25mg for days 1 and 2, then 50mg for days 3, 4, and 5) before either the first or second scanning session.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who received Placebo capsules for 5 days before either the first or second scanning session'}], 'classes': [{'categories': [{'measurements': [{'value': '0.25', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '0.26', 'spread': '0.10', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'one week', 'description': 'Percent signal change relative to baseline in the nucleus accumbens during cue to win $5 as assessed during functional MRI. Higher values of percent signal change indicate greater activation to reward. We will compare the active medication condition to the placebo, establishing whether there is a difference between the conditions.', 'unitOfMeasure': 'percentage signal change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The participants who completed the study were analyzed. They were all healthy adults who met inclusion/exclusion criteria.'}, {'type': 'SECONDARY', 'title': 'Alcohol Value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Naltrexone', 'description': 'Participants who received Naltrexone capsules for 5 days (25mg for days 1 and 2, then 50mg for days 3, 4, and 5) before either the first or second scanning session.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who received Placebo capsules before either the first or second scanning session.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.4', 'spread': '14.8', 'groupId': 'OG000'}, {'value': '19.9', 'spread': '17.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'one week', 'description': 'Maximum alcohol expenditure, or Omax, is the maximum amount of money that a person will pay for alcohol in a hypothetical alcohol consumption task called the "Alcohol Purchase Task". Higher values of Omax indicate that a person values consuming alcohol at a greater level.', 'unitOfMeasure': 'Dollars', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Healthy adults who completed the study'}, {'type': 'SECONDARY', 'title': 'Brain Activation to Emotion Regulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Naltrexone', 'description': 'Participants who received Naltrexone capsules for 5 days (25mg for days 1 and 2, then 50mg for days 3, 4, and 5) before either the first or second scanning session.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who received Placebo capsules before either the first or second scanning session.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'one week', 'description': 'Percent signal change from baseline in the amygdala during trials to regulate emotion relative to trials to passively experience emotion during a functional MRI scan. Cues will be negative images, and instructions will be either "decrease" or "look".', 'unitOfMeasure': 'percentage signal change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Healthy Adults: Placebo First, Then Naltrexone', 'description': 'This arm will receive placebo first, then active medication second\n\nNaltrexone: Naltrexone is an opioid antagonist with primary action at the mu opioid receptor.\n\nPlacebo: Placebo will be used to control for expectancy effects'}, {'id': 'FG001', 'title': 'Healthy Adults: Active Medication First, Then Placebo', 'description': 'This arm will receive active medication first, then placebo second\n\nNaltrexone: Naltrexone is an opioid antagonist with primary action at the mu opioid receptor.\n\nPlacebo: Placebo will be used to control for expectancy effects'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Healthy Adults: Placebo First', 'description': 'This arm will receive placebo first, then active medication second\n\nNaltrexone: Naltrexone is an opioid antagonist with primary action at the mu opioid receptor.\n\nPlacebo: Placebo will be used to control for expectancy effects'}, {'id': 'BG001', 'title': 'Healthy Adults: Active Medication First', 'description': 'This arm will receive active medication first, then placebo second\n\nNaltrexone: Naltrexone is an opioid antagonist with primary action at the mu opioid receptor.\n\nPlacebo: Placebo will be used to control for expectancy effects'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '24.8', 'spread': '4.4', 'groupId': 'BG000'}, {'value': '24.0', 'spread': '4.4', 'groupId': 'BG001'}, {'value': '24.2', 'spread': '4.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', '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'}, {'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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', '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'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Healthy young adults'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-10-28', 'size': 524187, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-05-15T11:50', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'capsule, double blind'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Participants will be counterbalanced for the order they undergo placebo and medication.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2022-04-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-06', 'studyFirstSubmitDate': '2021-04-08', 'resultsFirstSubmitDate': '2023-05-15', 'studyFirstSubmitQcDate': '2021-04-19', 'lastUpdatePostDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-11-06', 'studyFirstPostDateStruct': {'date': '2021-04-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Brain Activation to Reward Between Placebo and Active Medication', 'timeFrame': 'one week', 'description': 'Percent signal change relative to baseline in the nucleus accumbens during cue to win $5 as assessed during functional MRI. Higher values of percent signal change indicate greater activation to reward. We will compare the active medication condition to the placebo, establishing whether there is a difference between the conditions.'}], 'secondaryOutcomes': [{'measure': 'Alcohol Value', 'timeFrame': 'one week', 'description': 'Maximum alcohol expenditure, or Omax, is the maximum amount of money that a person will pay for alcohol in a hypothetical alcohol consumption task called the "Alcohol Purchase Task". Higher values of Omax indicate that a person values consuming alcohol at a greater level.'}, {'measure': 'Brain Activation to Emotion Regulation', 'timeFrame': 'one week', 'description': 'Percent signal change from baseline in the amygdala during trials to regulate emotion relative to trials to passively experience emotion during a functional MRI scan. Cues will be negative images, and instructions will be either "decrease" or "look".'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alcohol Drinking', 'Opioid Use, Unspecified']}, 'referencesModule': {'references': [{'pmid': '37530456', 'type': 'DERIVED', 'citation': 'Gowin JL, Sloan ME, Kirk-Provencher KT, Rosenblatt SL, Penner AE, Stangl BL, Byrd ND, Swan JE, Ramchandani VA. Opioid receptor antagonism and neural response to monetary rewards: Pilot studies in light and heavy alcohol users. J Psychopharmacol. 2023 Sep;37(9):937-941. doi: 10.1177/02698811231191707. Epub 2023 Aug 2.'}]}, 'descriptionModule': {'briefSummary': "This is a double blind study of the effects of opioid antagonism on the brain's reward response. The investigators will recruit participants to undergo two scans, one on active medication and one on placebo. During the scan, the investigators will assess reward.", 'detailedDescription': 'The study will employ a crossover design. The study will use the monetary incentive delay task during functional MRI to assess reward. This task presents participants with cues indicating whether they are playing to win $5, win $0, or to avoid losing $5. This task has been well-validated to elicit activation in a key reward response area of the brain called the ventral striatum.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between 18 and 35 years of age,\n* Is a moderate drinker (i.e. consumes 1-14 drinks/week for males, or 1-7 drinks/week for females).\n\nExclusion Criteria:\n\n* Non-drinker\n* Positive result on urine drug screen or breathalyzer at the start of any study visit\n* Inability to complete MRI (e.g. presence of ferromagnetic objects in body)\n* Current use of medications that alter the hemodynamic response such as insulin\n* History of trauma resulting in loss of consciousness longer than 15 minutes\n* Currently taking opioid medications\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT04854551', 'briefTitle': 'Opioid Modulation and Neural Reward Activation in Healthy Adults', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Opioid Modulation and Neural Reward Activation in Healthy Adults', 'orgStudyIdInfo': {'id': '21-2886'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Placebo, Then Naltrexone', 'description': 'Participants first received placebo capsules each day in a blister pack for 5 days. After a washout period of at least 3 days, they then received naltrexone capsules (matching placebo capsules) at 25mg/day for days 1 and 2 and then 50mg/day for days 3-5 for 5 days.', 'interventionNames': ['Drug: Naltrexone', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Naltrexone, Then Placebo', 'description': 'Participants first received naltrexone capsules each day in a blister pack for 5 days. Days 1 and 2 were at 25mg/day, and days 3-5 were at 50mg/day. After a washout period of at least 3 days, they then received placebo capsules (matching naltrexone capsules) for 5 days.', 'interventionNames': ['Drug: Naltrexone', 'Other: Placebo']}], 'interventions': [{'name': 'Naltrexone', 'type': 'DRUG', 'description': 'Naltrexone is an opioid antagonist with primary action at the mu opioid receptor.', 'armGroupLabels': ['Naltrexone, Then Placebo', 'Placebo, Then Naltrexone']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo will be used to control for expectancy effects', 'armGroupLabels': ['Naltrexone, Then Placebo', 'Placebo, Then Naltrexone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Anschutz Medical Campus', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'overallOfficials': [{'name': 'Joshua Gowin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'The investigators would either upload to an online repository or share directly with individuals wishing to access it.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}