Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2026-01-01 @ 7:32 AM
Study NCT ID:
NCT01822132
Status:
COMPLETED
Last Update Posted:
2019-03-05
First Post:
2013-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Risky Decision Making in Methamphetamine Users: The Role of Opioid Blockade
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000624616', 'term': 'vivitrol'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'korthuis@ohsu.edu', 'phone': '503-494-8044', 'title': 'Dr. Todd Korthuis', 'organization': 'Oregon Health & Science University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Extended Release Naltrexone', 'description': 'One dose of intramuscular injection of 380mg extended-release naltrexone.\n\nExtended release naltrexone', 'otherNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'One dose of intramuscular injection of placebo.\n\nPlacebo', 'otherNumAtRisk': 27, 'otherNumAffected': 0, 'seriousNumAtRisk': 27, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Discounting Tasks: Sexual Probability Discounting (SexPD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Naltrexone', 'description': 'Participants who were randomized to naltrexone.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who were randomized to receive placebo.'}], 'classes': [{'title': 'Baseline_All', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.97', 'spread': '11.07', 'groupId': 'OG000'}, {'value': '6.52', 'spread': '8.52', 'groupId': 'OG001'}]}]}, {'title': 'Post_All', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.68', 'spread': '12.07', 'groupId': 'OG000'}, {'value': '7.67', 'spread': '11.74', 'groupId': 'OG001'}]}]}, {'title': 'Post_HIV-positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.54', 'spread': '5.16', 'groupId': 'OG000'}, {'value': '1.08', 'spread': '2.84', 'groupId': 'OG001'}]}]}, {'title': 'Post_HIV-negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.55', 'spread': '13.39', 'groupId': 'OG000'}, {'value': '9.79', 'spread': '13.38', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '28 days post drug intervention', 'description': 'In the SexPD task, subjects are asked to choose between having sex with a more appealing partner with a varying chance of having a sexually transmitted infection (STI) or a less appealing partner with no STI.\n\nA hyperbolic decay model was used to calculate h, a free parameter that indexes the rate of probabilistic discounting. Smaller h values indicate a preference for probabilistic (i.e., riskier) outcomes. To normalize the data, the natural log of h values were calculated and reported here.', 'unitOfMeasure': 'natural log', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with methamphetamine dependence and either HIV positive or not, all abstaining from opioids for at least 30 days.'}, {'type': 'PRIMARY', 'title': 'Discounting Tasks: Standard Delay Discounting (DD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Naltrexone', 'description': 'One dose of intramuscular injection of 380mg extended-release naltrexone.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'One dose of intramuscular injection of placebo.'}], 'classes': [{'title': 'Baseline_All', 'categories': [{'measurements': [{'value': '-2.92', 'spread': '6.06', 'groupId': 'OG000'}, {'value': '-3.90', 'spread': '2.04', 'groupId': 'OG001'}]}]}, {'title': 'Post_All', 'categories': [{'measurements': [{'value': '-2.73', 'spread': '7.76', 'groupId': 'OG000'}, {'value': '-4.25', 'spread': '1.65', 'groupId': 'OG001'}]}]}, {'title': 'Post_HIV-positive', 'categories': [{'measurements': [{'value': '-5.44', 'spread': '1.48', 'groupId': 'OG000'}, {'value': '-5.56', 'spread': '1.61', 'groupId': 'OG001'}]}]}, {'title': 'Post_HIV-negative', 'categories': [{'measurements': [{'value': '-1.57', 'spread': '9.08', 'groupId': 'OG000'}, {'value': '-3.88', 'spread': '1.50', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '28 days post drug intervention', 'description': 'Monetary delay discounting task consisted of choosing between a larger, delayed and a smaller, immediate reward. A hyperbolic decay model was used to calculate k, a free parameter that indexes the rate of delay discounting. As k values are typically skewed across subjects, the distribution of k was normalized by using a natural log transformation. The normalized values are reported here. If k typically ranges between 0.5 and 10\\^-5, then the natural log of k will range between -0.69 and -11.5. Larger normalized k values indicate a preference for smaller sooner outcomes (i.e., more impulsive decision-making).', 'unitOfMeasure': 'natural log', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with methamphetamine dependence and either HIV positive or not, all abstaining from opioids for at least 30 days.'}, {'type': 'PRIMARY', 'title': 'Barrat Impulsiveness Scale (BIS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Naltrexone', 'description': 'Participants randomized to naltrexone.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants randomized to placebo.'}], 'classes': [{'title': 'Baseline_All', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '77.5', 'spread': '14.24', 'groupId': 'OG000'}, {'value': '73.52', 'spread': '13.16', 'groupId': 'OG001'}]}]}, {'title': 'Post_All', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '71.79', 'spread': '10.07', 'groupId': 'OG000'}, {'value': '63.30', 'spread': '11.53', 'groupId': 'OG001'}]}]}, {'title': 'Post_HIV-positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70.83', 'spread': '7.49', 'groupId': 'OG000'}, {'value': '61', 'spread': '13.15', 'groupId': 'OG001'}]}]}, {'title': 'Post_HIV-negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.23', 'spread': '11.31', 'groupId': 'OG000'}, {'value': '64.47', 'spread': '11.70', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '28 days post drug intervention', 'description': 'The Barrat Impulsiveness Scale (BIS) is a 30 item questionnaire to measure a persons impulsiveness. Items are answered on a 4-point scale and scored 1-4 then summed across responses. Total scores range from 30-120 with a higher summed score indicating higher impulsivity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with methamphetamine dependence and either HIV positive or not, all abstaining from opioids for at least 30 days.'}, {'type': 'PRIMARY', 'title': 'Risk Assessment Battery (RAB)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Naltrexone', 'description': 'One dose of intramuscular injection of 380mg extended-release naltrexone.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'One dose of intramuscular injection of placebo.'}], 'classes': [{'title': 'DrugRisk_Baseline_All', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.33', 'spread': '2.92', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '1.87', 'groupId': 'OG001'}]}]}, {'title': 'DrugRisk_Post_All', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.24', 'spread': '0.54', 'groupId': 'OG000'}, {'value': '0.08', 'spread': '0.40', 'groupId': 'OG001'}]}]}, {'title': 'SexRisk_Baseline_All', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.48', 'spread': '3.23', 'groupId': 'OG000'}, {'value': '4.44', 'spread': '3.16', 'groupId': 'OG001'}]}]}, {'title': 'SexRisk_Post_All', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.81', 'spread': '2.75', 'groupId': 'OG000'}, {'value': '4.72', 'spread': '2.89', 'groupId': 'OG001'}]}]}, {'title': 'TotalRisk_Baseline_All', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.17', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '0.13', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': 'TotalRisk_Post_All', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '0.12', 'spread': '0.07', 'groupId': 'OG001'}]}]}, {'title': 'DrugRisk_Baseline_HIV-positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'spread': '1.67', 'groupId': 'OG000'}, {'value': '0.17', 'spread': '0.41', 'groupId': 'OG001'}]}]}, {'title': 'DrugRisk_Post_HIV-positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'SexRisk_Baseline_HIV-positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.5', 'spread': '4.04', 'groupId': 'OG000'}, {'value': '5.17', 'spread': '2.64', 'groupId': 'OG001'}]}]}, {'title': 'SexRisk_Post_HIV-positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.83', 'spread': '3.76', 'groupId': 'OG000'}, {'value': '4.17', 'spread': '1.83', 'groupId': 'OG001'}]}]}, {'title': 'TotalRisk_Baseline_HIV-positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.19', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '0.13', 'spread': '0.06', 'groupId': 'OG001'}]}]}, {'title': 'TotalRisk_Post_HIV-positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.15', 'spread': '0.094', 'groupId': 'OG000'}, {'value': '0.10', 'spread': '0.05', 'groupId': 'OG001'}]}]}, {'title': 'DrugRisk_Baseline_HIV-negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.47', 'spread': '3.34', 'groupId': 'OG000'}, {'value': '0.74', 'spread': '2.13', 'groupId': 'OG001'}]}]}, {'title': 'DrugRisk_Post_HIV-negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.33', 'spread': '0.62', 'groupId': 'OG000'}, {'value': '0.11', 'spread': '0.46', 'groupId': 'OG001'}]}]}, {'title': 'SexRisk_Baseline_HIV-negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.07', 'spread': '2.91', 'groupId': 'OG000'}, {'value': '4.21', 'spread': '3.34', 'groupId': 'OG001'}]}]}, {'title': 'SexRisk_Post_HIV-negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.4', 'spread': '2.26', 'groupId': 'OG000'}, {'value': '4.89', 'spread': '3.18', 'groupId': 'OG001'}]}]}, {'title': 'TotalRisk_Baseline_HIV-negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.16', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '0.12', 'spread': '0.095', 'groupId': 'OG001'}]}]}, {'title': 'TotalRisk_Post_HIV-negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.12', 'spread': '0.055', 'groupId': 'OG000'}, {'value': '0.13', 'spread': '0.081', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '28 days post drug intervention', 'description': 'The Risk Assessment Battery (RAB) is a 26 question self-administered assessment focusing on drug use, injection and sexual risk during the past 30 days.\n\nThree composite HIV risk scores (drug, sex, and total score) are calculated. The questions have different numbers of items, and scores for a single question can range from 0 to 7, with higher values reflecting more instances of risk behavior. The drug risk score has a range of 0 to 22 and is calculated from 8 questions that address recent substance use, including frequency, needle sharing, and cleaning of the "works." 9 questions are used to calculate a sex risk score that has a range of 0 to 18, and these questions address the frequency and types of sexual behavior, HIV status of sexual partners, and type of protection that was used (if any). Total score is calculated by adding drug and sex scores and dividing by 40, the maximum score possible, and ranges from 0 to 40 where higher scores indicate greater risk behavior.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with methamphetamine dependence and either HIV positive or not, all abstaining from opioids for at least 30 days.'}, {'type': 'SECONDARY', 'title': 'Methamphetamine Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended Release Naltrexone', 'description': 'One dose of intramuscular injection of 380mg extended-release naltrexone.\n\nExtended release naltrexone'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'One dose of intramuscular injection of placebo.\n\nPlacebo'}], 'classes': [{'title': 'Post_All', 'categories': [{'measurements': [{'value': '1.33', 'spread': '3.23', 'groupId': 'OG000'}, {'value': '2.17', 'spread': '5.52', 'groupId': 'OG001'}]}]}, {'title': 'Post_HIV-positive', 'categories': [{'measurements': [{'value': '1.17', 'spread': '1.83', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '3.58', 'groupId': 'OG001'}]}]}, {'title': 'Post_HIV-negative', 'categories': [{'measurements': [{'value': '1.4', 'spread': '3.70', 'groupId': 'OG000'}, {'value': '0.13', 'spread': '0.52', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '28 days post drug intervention', 'description': 'Participants were asked "How many days in the past 30 days did you use methamphetamine?". This is a self-report measure.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with methamphetamine dependence and either HIV positive or not, all abstaining from opioids for at least 30 days.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Naltrexone', 'description': 'One dose of intramuscular injection of 380mg extended-release naltrexone.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'One dose of intramuscular injection of placebo.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': 'After consenting, 13 participants did not meet screening inclusion criteria and were removed from the study and 11 participants withdrew, leaving 52 eligible participants for randomization into a treatment group (Naltrexone or Placebo)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Extended Release Naltrexone', 'description': 'One dose of intramuscular injection of 380mg extended-release naltrexone.\n\nExtended release naltrexone'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'One dose of intramuscular injection of placebo.\n\nPlacebo'}, {'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': '25', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '52', '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': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '46', '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': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-12', 'studyFirstSubmitDate': '2013-03-21', 'resultsFirstSubmitDate': '2017-09-20', 'studyFirstSubmitQcDate': '2013-03-27', 'lastUpdatePostDateStruct': {'date': '2019-03-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-01-16', 'studyFirstPostDateStruct': {'date': '2013-04-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Discounting Tasks: Sexual Probability Discounting (SexPD)', 'timeFrame': '28 days post drug intervention', 'description': 'In the SexPD task, subjects are asked to choose between having sex with a more appealing partner with a varying chance of having a sexually transmitted infection (STI) or a less appealing partner with no STI.\n\nA hyperbolic decay model was used to calculate h, a free parameter that indexes the rate of probabilistic discounting. Smaller h values indicate a preference for probabilistic (i.e., riskier) outcomes. To normalize the data, the natural log of h values were calculated and reported here.'}, {'measure': 'Discounting Tasks: Standard Delay Discounting (DD)', 'timeFrame': '28 days post drug intervention', 'description': 'Monetary delay discounting task consisted of choosing between a larger, delayed and a smaller, immediate reward. A hyperbolic decay model was used to calculate k, a free parameter that indexes the rate of delay discounting. As k values are typically skewed across subjects, the distribution of k was normalized by using a natural log transformation. The normalized values are reported here. If k typically ranges between 0.5 and 10\\^-5, then the natural log of k will range between -0.69 and -11.5. Larger normalized k values indicate a preference for smaller sooner outcomes (i.e., more impulsive decision-making).'}, {'measure': 'Barrat Impulsiveness Scale (BIS)', 'timeFrame': '28 days post drug intervention', 'description': 'The Barrat Impulsiveness Scale (BIS) is a 30 item questionnaire to measure a persons impulsiveness. Items are answered on a 4-point scale and scored 1-4 then summed across responses. Total scores range from 30-120 with a higher summed score indicating higher impulsivity.'}, {'measure': 'Risk Assessment Battery (RAB)', 'timeFrame': '28 days post drug intervention', 'description': 'The Risk Assessment Battery (RAB) is a 26 question self-administered assessment focusing on drug use, injection and sexual risk during the past 30 days.\n\nThree composite HIV risk scores (drug, sex, and total score) are calculated. The questions have different numbers of items, and scores for a single question can range from 0 to 7, with higher values reflecting more instances of risk behavior. The drug risk score has a range of 0 to 22 and is calculated from 8 questions that address recent substance use, including frequency, needle sharing, and cleaning of the "works." 9 questions are used to calculate a sex risk score that has a range of 0 to 18, and these questions address the frequency and types of sexual behavior, HIV status of sexual partners, and type of protection that was used (if any). Total score is calculated by adding drug and sex scores and dividing by 40, the maximum score possible, and ranges from 0 to 40 where higher scores indicate greater risk behavior.'}], 'secondaryOutcomes': [{'measure': 'Methamphetamine Use', 'timeFrame': '28 days post drug intervention', 'description': 'Participants were asked "How many days in the past 30 days did you use methamphetamine?". This is a self-report measure.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Methamphetamine Abuse', 'HIV']}, 'referencesModule': {'references': [{'pmid': '31551824', 'type': 'DERIVED', 'citation': 'Kohno M, Morales AM, Dennis LE, McCready H, Hoffman WF, Korthuis PT. Effects of Naltrexone on Large-Scale Network Interactions in Methamphetamine Use Disorder. Front Psychiatry. 2019 Sep 3;10:603. doi: 10.3389/fpsyt.2019.00603. eCollection 2019.'}, {'pmid': '30266003', 'type': 'DERIVED', 'citation': 'Kohno M, Dennis LE, McCready H, Schwartz DL, Hoffman WF, Korthuis PT. A preliminary randomized clinical trial of naltrexone reduces striatal resting state functional connectivity in people with methamphetamine use disorder. Drug Alcohol Depend. 2018 Nov 1;192:186-192. doi: 10.1016/j.drugalcdep.2018.07.045. Epub 2018 Sep 21.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this protocol is to learn more about impulsive decision making in people who use methamphetamines. The investigators would like to know if a medication called naltrexone changes how people make decisions. The investigators would also like to know whether changes in decision making can be observed by MRI (magnetic resonance imaging).\n\nThe research is conducted in Portland, OR.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Summary Inclusion Criteria:\n\n* Diagnostic and Statistical Manual (DSM)-IV Methamphetamine Dependence\n* Deemed healthy enough to participate by study physician\n* Age 18-55\n* Right handed\n* English-speaking\n\nSummary Exclusion Criteria:\n\n* Current opioid use in the last 30 days; opioid abuse or dependence within past 5 years\n* Pregnancy\n* MRI contraindications (e.g. metal in head).\n\nThe research is conducted in Portland, OR.'}, 'identificationModule': {'nctId': 'NCT01822132', 'briefTitle': 'Risky Decision Making in Methamphetamine Users: The Role of Opioid Blockade', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'Risky Decision Making in Methamphetamine Users: The Role of Opioid Blockade', 'orgStudyIdInfo': {'id': 'ALKIIT-KOR-034'}, 'secondaryIdInfos': [{'id': '1R21DA033182-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R21DA033182-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Extended release naltrexone', 'description': 'One dose of intramuscular injection of 380mg extended-release naltrexone.', 'interventionNames': ['Drug: Extended release naltrexone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'One dose of intramuscular injection of placebo.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Extended release naltrexone', 'type': 'DRUG', 'otherNames': ['Vivitrol'], 'armGroupLabels': ['Extended release naltrexone']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Portland VA Medical Center', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Philip T Korthuis, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Health and Science University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'P. Todd Korthuis, MD', 'investigatorAffiliation': 'Oregon Health and Science University'}}}}