Ignite Creation Date:
2025-12-24 @ 5:54 PM
Ignite Modification Date:
2025-12-29 @ 8:53 PM
Study NCT ID:
NCT04139668
Status:
TERMINATED
Last Update Posted:
2025-02-07
First Post:
2019-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Vivitrol Treatment for Cannabis Use Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009271', 'term': 'Naltrexone'}, {'id': 'C000624616', 'term': 'vivitrol'}, {'id': 'D062405', 'term': 'Motivational Interviewing'}, {'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], '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'}, {'id': 'D037001', 'term': 'Directive Counseling'}, {'id': 'D003376', 'term': 'Counseling'}, {'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bernard.lefoll@camh.ca', 'phone': '416-535-8501', 'title': 'Dr. Bernard Le Foll', 'phoneExt': '33111', 'organization': 'Centre for Addiction and Mental Health'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '6 weeks', 'description': 'Use of SAFTEE guidelines to capture AEs at every visit following consent', 'eventGroups': [{'id': 'EG000', 'title': 'Vivitrol + MET/CBT', 'description': 'All participants will receive three 4ml doses of extended-release naltrexone 380mg (Vivitrol), administered by intramuscular injection. Three injections will be administered to each participant; one injection every 4 weeks for 12 weeks of treatment. In addition, all participants will receive weekly Motivational Enhancement Therapy and Cognitive Behavioral Therapy for 12 weeks.\n\nNaltrexone 380 MG \\[Vivitrol\\]: Three 4ml intramuscular injections of naltrexone 380mg (Vivitrol) administered over 12 weeks (one injection every 4 weeks)\n\nMotivational Enhancement Therapy and Cognitive Behavioral Therapy: Weekly Motivational Enhancement Therapy and Cognitive Behavioral Therapy (MET/CBT), based upon the Brief Counselling for Marijuana Dependence Manual published by the Substance Abuse and Mental Health Services Administration (SAMHSA), for 12 weeks', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hair loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Dropouts Due to Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vivitrol + MET/CBT', 'description': 'All participants will receive three 4ml doses of extended-release naltrexone 380mg (Vivitrol), administered by intramuscular injection. Three injections will be administered to each participant; one injection every 4 weeks for 12 weeks of treatment. In addition, all participants will receive weekly Motivational Enhancement Therapy and Cognitive Behavioral Therapy for 12 weeks.\n\nNaltrexone 380 MG \\[Vivitrol\\]: Three 4ml intramuscular injections of naltrexone 380mg (Vivitrol) administered over 12 weeks (one injection every 4 weeks)\n\nMotivational Enhancement Therapy and Cognitive Behavioral Therapy: Weekly Motivational Enhancement Therapy and Cognitive Behavioral Therapy (MET/CBT), based upon the Brief Counselling for Marijuana Dependence Manual published by the Substance Abuse and Mental Health Services Administration (SAMHSA), for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At end of 12 weeks treatment', 'description': 'Tolerability will be measured by the number of participants that drop out of the study because of serious adverse events. Adverse events will be monitored weekly during the 12 week treatment phase of the study', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 1 participant was enrolled, and this participant withdrew prior to completion at 6 weeks; data are reported up to 6 weeks.'}, {'type': 'PRIMARY', 'title': 'Dropouts Due to Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vivitrol + MET/CBT', 'description': 'All participants will receive three 4ml doses of extended-release naltrexone 380mg (Vivitrol), administered by intramuscular injection. Three injections will be administered to each participant; one injection every 4 weeks for 12 weeks of treatment. In addition, all participants will receive weekly Motivational Enhancement Therapy and Cognitive Behavioral Therapy for 12 weeks.\n\nNaltrexone 380 MG \\[Vivitrol\\]: Three 4ml intramuscular injections of naltrexone 380mg (Vivitrol) administered over 12 weeks (one injection every 4 weeks)\n\nMotivational Enhancement Therapy and Cognitive Behavioral Therapy: Weekly Motivational Enhancement Therapy and Cognitive Behavioral Therapy (MET/CBT), based upon the Brief Counselling for Marijuana Dependence Manual published by the Substance Abuse and Mental Health Services Administration (SAMHSA), for 12 weeks'}], 'timeFrame': 'At 3 months follow-up', 'description': 'Tolerability will be measured by the number of participants that drop out of the study because of serious adverse events. After the treatment phase of the study adverse events will be monitored weekly for the first 4 weeks follow-up, and then monthly until the final follow-up at 3 months post-treatment', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 1 participant was enrolled, and this participant withdrew prior to completion at 6 weeks. Since no participant completed the study and made it to the 3-month follow-up phase, there is no data to report for this outcome.'}, {'type': 'PRIMARY', 'title': 'Cannabis Abstinence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vivitrol + MET/CBT', 'description': 'All participants will receive three 4ml doses of extended-release naltrexone 380mg (Vivitrol), administered by intramuscular injection. Three injections will be administered to each participant; one injection every 4 weeks for 12 weeks of treatment. In addition, all participants will receive weekly Motivational Enhancement Therapy and Cognitive Behavioral Therapy for 12 weeks.\n\nNaltrexone 380 MG \\[Vivitrol\\]: Three 4ml intramuscular injections of naltrexone 380mg (Vivitrol) administered over 12 weeks (one injection every 4 weeks)\n\nMotivational Enhancement Therapy and Cognitive Behavioral Therapy: Weekly Motivational Enhancement Therapy and Cognitive Behavioral Therapy (MET/CBT), based upon the Brief Counselling for Marijuana Dependence Manual published by the Substance Abuse and Mental Health Services Administration (SAMHSA), for 12 weeks'}], 'timeFrame': 'At end of 12 weeks treatment', 'description': 'Seven-day point prevalence of cannabis abstinence. Abstinence will be measured using a self-report timeline follow-back (TLFB) calendar method, and will be confirmed by urine drug screens.', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 1 participant was enrolled and this participant withdrew at 6 weeks, so data were not collected for this Outcome Measure.'}, {'type': 'PRIMARY', 'title': 'Cannabis Abstinence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vivitrol + MET/CBT', 'description': 'All participants will receive three 4ml doses of extended-release naltrexone 380mg (Vivitrol), administered by intramuscular injection. Three injections will be administered to each participant; one injection every 4 weeks for 12 weeks of treatment. In addition, all participants will receive weekly Motivational Enhancement Therapy and Cognitive Behavioral Therapy for 12 weeks.\n\nNaltrexone 380 MG \\[Vivitrol\\]: Three 4ml intramuscular injections of naltrexone 380mg (Vivitrol) administered over 12 weeks (one injection every 4 weeks)\n\nMotivational Enhancement Therapy and Cognitive Behavioral Therapy: Weekly Motivational Enhancement Therapy and Cognitive Behavioral Therapy (MET/CBT), based upon the Brief Counselling for Marijuana Dependence Manual published by the Substance Abuse and Mental Health Services Administration (SAMHSA), for 12 weeks'}], 'timeFrame': 'At 3 month follow-up', 'description': 'Seven-day point prevalence of cannabis abstinence. Abstinence will be measured using a self-report timeline follow-back (TLFB) calendar method, and will be confirmed by urine drug screens.', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 1 participant was enrolled and this participant withdrew at 6 weeks, so data were not collected for this Outcome Measure.'}, {'type': 'SECONDARY', 'title': 'Days Cannabis Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vivitrol + MET/CBT', 'description': 'All participants will receive three 4ml doses of extended-release naltrexone 380mg (Vivitrol), administered by intramuscular injection. Three injections will be administered to each participant; one injection every 4 weeks for 12 weeks of treatment. In addition, all participants will receive weekly Motivational Enhancement Therapy and Cognitive Behavioral Therapy for 12 weeks.\n\nNaltrexone 380 MG \\[Vivitrol\\]: Three 4ml intramuscular injections of naltrexone 380mg (Vivitrol) administered over 12 weeks (one injection every 4 weeks)\n\nMotivational Enhancement Therapy and Cognitive Behavioral Therapy: Weekly Motivational Enhancement Therapy and Cognitive Behavioral Therapy (MET/CBT), based upon the Brief Counselling for Marijuana Dependence Manual published by the Substance Abuse and Mental Health Services Administration (SAMHSA), for 12 weeks'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During 12 weeks of treatment and up to 3 month follow-up', 'description': 'Percentage of days of cannabis use. This will be calculated using a self-report timeline follow-back (TLFB) calendar method', 'unitOfMeasure': 'Percentage of days/week', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 1 participant was enrolled, and this participant withdrew prior to completion at 6 weeks; data are reported up to 6 weeks.'}, {'type': 'SECONDARY', 'title': 'Amount Cannabis Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vivitrol + MET/CBT', 'description': 'All participants will receive three 4ml doses of extended-release naltrexone 380mg (Vivitrol), administered by intramuscular injection. Three injections will be administered to each participant; one injection every 4 weeks for 12 weeks of treatment. In addition, all participants will receive weekly Motivational Enhancement Therapy and Cognitive Behavioral Therapy for 12 weeks.\n\nNaltrexone 380 MG \\[Vivitrol\\]: Three 4ml intramuscular injections of naltrexone 380mg (Vivitrol) administered over 12 weeks (one injection every 4 weeks)\n\nMotivational Enhancement Therapy and Cognitive Behavioral Therapy: Weekly Motivational Enhancement Therapy and Cognitive Behavioral Therapy (MET/CBT), based upon the Brief Counselling for Marijuana Dependence Manual published by the Substance Abuse and Mental Health Services Administration (SAMHSA), for 12 weeks'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During 12 weeks of treatment and up to 3 month follow-up', 'description': 'Amount of cannabis used (grams per week). The amount of cannabis consumed will be measured using a self-report timeline follow-back (TLFB) calendar method', 'unitOfMeasure': 'g/week of cannabis', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 1 participant was enrolled, and this participant withdrew prior to completion at 6 weeks; data are reported up to 6 weeks.'}, {'type': 'SECONDARY', 'title': 'Cannabis Withdrawal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vivitrol + MET/CBT', 'description': 'All participants will receive three 4ml doses of extended-release naltrexone 380mg (Vivitrol), administered by intramuscular injection. Three injections will be administered to each participant; one injection every 4 weeks for 12 weeks of treatment. In addition, all participants will receive weekly Motivational Enhancement Therapy and Cognitive Behavioral Therapy for 12 weeks.\n\nNaltrexone 380 MG \\[Vivitrol\\]: Three 4ml intramuscular injections of naltrexone 380mg (Vivitrol) administered over 12 weeks (one injection every 4 weeks)\n\nMotivational Enhancement Therapy and Cognitive Behavioral Therapy: Weekly Motivational Enhancement Therapy and Cognitive Behavioral Therapy (MET/CBT), based upon the Brief Counselling for Marijuana Dependence Manual published by the Substance Abuse and Mental Health Services Administration (SAMHSA), for 12 weeks'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Week 5', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During 12 weeks of treatment and up to 3 month follow-up', 'description': 'Withdrawal symptom scores. Cannabis withdrawal symptoms will be measured using the Marijuana Withdrawal Checklist (MWC). The 16 item MWC indicates severity of withdrawal in the previous 24 hours. Each item is scored 0-4 (where 4=severe) and the scale is summed. The outcome variable is the total score (the sum of each individual item score), which can vary from 0 to 64; higher scores indicate a worse outcome (i.e., more number/severity of withdrawal symptoms).', 'unitOfMeasure': 'score on a scale', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 1 participant was enrolled, and this participant withdrew prior to completion at 6 weeks; data are reported up to 6 weeks.'}, {'type': 'SECONDARY', 'title': 'Cannabis Craving', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vivitrol + MET/CBT', 'description': 'All participants will receive three 4ml doses of extended-release naltrexone 380mg (Vivitrol), administered by intramuscular injection. Three injections will be administered to each participant; one injection every 4 weeks for 12 weeks of treatment. In addition, all participants will receive weekly Motivational Enhancement Therapy and Cognitive Behavioral Therapy for 12 weeks.\n\nNaltrexone 380 MG \\[Vivitrol\\]: Three 4ml intramuscular injections of naltrexone 380mg (Vivitrol) administered over 12 weeks (one injection every 4 weeks)\n\nMotivational Enhancement Therapy and Cognitive Behavioral Therapy: Weekly Motivational Enhancement Therapy and Cognitive Behavioral Therapy (MET/CBT), based upon the Brief Counselling for Marijuana Dependence Manual published by the Substance Abuse and Mental Health Services Administration (SAMHSA), for 12 weeks'}], 'classes': [{'title': 'Week 1 Compulsivity', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Week 1 Emotionality', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Week 1 Expectancy', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Week 1 Purposefulness', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Week 2 Compulsivity', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Week 2 Emotionality', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Week 2 Expectancy', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Week 2 Purposefulness', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Week 3 Compulsivity', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Week 3 Emotionality', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Week 3 Expectancy', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Week 3 Purposefulness', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 Compulsivity', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 Emotionality', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 Expectancy', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 Purposefulness', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Week 5 Compulsivity', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Week 5 Emotionality', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Week 5 Expectancy', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Week 5 Purposefulness', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Week 6 Compulsivity', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Week 6 Emotionality', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Week 6 Expectancy', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Week 6 Purposefulness', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During 12 weeks of treatment and up to 3 month follow-up', 'description': 'Craving symptom scores. Cannabis craving will be measured using the Marijuana Craving Questionnaire (MCQ). The 12-item MCQ assesses craving along 4 dimensions: compulsivity, emotionality, expectancy, and purposefulness. Each subscale is the sum of 3 items from the questionnaire. Each item is rated from 1 (strongly disagree) to 7 (strongly agree). Each subscale can thus vary from 3 to 21, where higher scores represent more craving (worse outcome).', 'unitOfMeasure': 'score on a scale', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 1 participant was enrolled, and this participant withdrew prior to completion at 6 weeks; data are reported up to 6 weeks.'}, {'type': 'SECONDARY', 'title': 'Urine Cannabis Screens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vivitrol + MET/CBT', 'description': 'All participants will receive three 4ml doses of extended-release naltrexone 380mg (Vivitrol), administered by intramuscular injection. Three injections will be administered to each participant; one injection every 4 weeks for 12 weeks of treatment. In addition, all participants will receive weekly Motivational Enhancement Therapy and Cognitive Behavioral Therapy for 12 weeks.\n\nNaltrexone 380 MG \\[Vivitrol\\]: Three 4ml intramuscular injections of naltrexone 380mg (Vivitrol) administered over 12 weeks (one injection every 4 weeks)\n\nMotivational Enhancement Therapy and Cognitive Behavioral Therapy: Weekly Motivational Enhancement Therapy and Cognitive Behavioral Therapy (MET/CBT), based upon the Brief Counselling for Marijuana Dependence Manual published by the Substance Abuse and Mental Health Services Administration (SAMHSA), for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During 12 weeks of treatment and up to 3 month follow-up', 'description': 'Number of urine samples positive for cannabis use. Urine samples will be collected to perform THC metabolite analysis', 'unitOfMeasure': 'Total number of positive urine samples', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 1 participant was enrolled, and this participant withdrew prior to completion at 6 weeks; data are reported up to 6 weeks.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Vivitrol + MET/CBT', 'description': 'All participants will receive three 4ml doses of extended-release naltrexone 380mg (Vivitrol), administered by intramuscular injection. Three injections will be administered to each participant; one injection every 4 weeks for 12 weeks of treatment. In addition, all participants will receive weekly Motivational Enhancement Therapy and Cognitive Behavioral Therapy for 12 weeks.\n\nNaltrexone 380 MG \\[Vivitrol\\]: Three 4ml intramuscular injections of naltrexone 380mg (Vivitrol) administered over 12 weeks (one injection every 4 weeks)\n\nMotivational Enhancement Therapy and Cognitive Behavioral Therapy: Weekly Motivational Enhancement Therapy and Cognitive Behavioral Therapy (MET/CBT), based upon the Brief Counselling for Marijuana Dependence Manual published by the Substance Abuse and Mental Health Services Administration (SAMHSA), for 12 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Vivitrol + MET/CBT', 'description': 'All participants will receive three 4ml doses of extended-release naltrexone 380mg (Vivitrol), administered by intramuscular injection. Three injections will be administered to each participant; one injection every 4 weeks for 12 weeks of treatment. In addition, all participants will receive weekly Motivational Enhancement Therapy and Cognitive Behavioral Therapy for 12 weeks.\n\nNaltrexone 380 MG \\[Vivitrol\\]: Three 4ml intramuscular injections of naltrexone 380mg (Vivitrol) administered over 12 weeks (one injection every 4 weeks)\n\nMotivational Enhancement Therapy and Cognitive Behavioral Therapy: Weekly Motivational Enhancement Therapy and Cognitive Behavioral Therapy (MET/CBT), based upon the Brief Counselling for Marijuana Dependence Manual published by the Substance Abuse and Mental Health Services Administration (SAMHSA), for 12 weeks'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-04-20', 'size': 657044, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-10-18T11:15', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'Funder contract terminated', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-06-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2022-06-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-17', 'studyFirstSubmitDate': '2019-10-21', 'resultsFirstSubmitDate': '2022-10-19', 'studyFirstSubmitQcDate': '2019-10-23', 'lastUpdatePostDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-17', 'studyFirstPostDateStruct': {'date': '2019-10-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dropouts Due to Serious Adverse Events', 'timeFrame': 'At end of 12 weeks treatment', 'description': 'Tolerability will be measured by the number of participants that drop out of the study because of serious adverse events. Adverse events will be monitored weekly during the 12 week treatment phase of the study'}, {'measure': 'Dropouts Due to Serious Adverse Events', 'timeFrame': 'At 3 months follow-up', 'description': 'Tolerability will be measured by the number of participants that drop out of the study because of serious adverse events. After the treatment phase of the study adverse events will be monitored weekly for the first 4 weeks follow-up, and then monthly until the final follow-up at 3 months post-treatment'}, {'measure': 'Cannabis Abstinence', 'timeFrame': 'At end of 12 weeks treatment', 'description': 'Seven-day point prevalence of cannabis abstinence. Abstinence will be measured using a self-report timeline follow-back (TLFB) calendar method, and will be confirmed by urine drug screens.'}, {'measure': 'Cannabis Abstinence', 'timeFrame': 'At 3 month follow-up', 'description': 'Seven-day point prevalence of cannabis abstinence. Abstinence will be measured using a self-report timeline follow-back (TLFB) calendar method, and will be confirmed by urine drug screens.'}], 'secondaryOutcomes': [{'measure': 'Days Cannabis Use', 'timeFrame': 'During 12 weeks of treatment and up to 3 month follow-up', 'description': 'Percentage of days of cannabis use. This will be calculated using a self-report timeline follow-back (TLFB) calendar method'}, {'measure': 'Amount Cannabis Use', 'timeFrame': 'During 12 weeks of treatment and up to 3 month follow-up', 'description': 'Amount of cannabis used (grams per week). The amount of cannabis consumed will be measured using a self-report timeline follow-back (TLFB) calendar method'}, {'measure': 'Cannabis Withdrawal', 'timeFrame': 'During 12 weeks of treatment and up to 3 month follow-up', 'description': 'Withdrawal symptom scores. Cannabis withdrawal symptoms will be measured using the Marijuana Withdrawal Checklist (MWC). The 16 item MWC indicates severity of withdrawal in the previous 24 hours. Each item is scored 0-4 (where 4=severe) and the scale is summed. The outcome variable is the total score (the sum of each individual item score), which can vary from 0 to 64; higher scores indicate a worse outcome (i.e., more number/severity of withdrawal symptoms).'}, {'measure': 'Cannabis Craving', 'timeFrame': 'During 12 weeks of treatment and up to 3 month follow-up', 'description': 'Craving symptom scores. Cannabis craving will be measured using the Marijuana Craving Questionnaire (MCQ). The 12-item MCQ assesses craving along 4 dimensions: compulsivity, emotionality, expectancy, and purposefulness. Each subscale is the sum of 3 items from the questionnaire. Each item is rated from 1 (strongly disagree) to 7 (strongly agree). Each subscale can thus vary from 3 to 21, where higher scores represent more craving (worse outcome).'}, {'measure': 'Urine Cannabis Screens', 'timeFrame': 'During 12 weeks of treatment and up to 3 month follow-up', 'description': 'Number of urine samples positive for cannabis use. Urine samples will be collected to perform THC metabolite analysis'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cannabis Use Disorder']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the safety and effectiveness of 12 weeks treatment with an extended-release injectable form of naltrexone (Vivitrol) combined with a psychological intervention in 10 treatment-seeking adults with Cannabis Use Disorder. The hypotheses are that Vivitrol combined with a psychological intervention will be well tolerated, and will reduce cannabis use, improve abstinence rates, and reduce cannabis withdrawal and craving.', 'detailedDescription': 'This study will be an open-label trial, with no placebo control. Ten male or female treatment-seeking adults with Cannabis Use Disorder (CUD) will be recruited. All participants will receive 3 x 4ml intramuscular injections of Vivitrol (380mg naltrexone). Injections will be administered once every 4 weeks for 12 weeks. In addition, all participants will receive a weekly psychological intervention (Motivational Enhancement Therapy and Cognitive Behavioral Therapy; MET/CBT) for 12 weeks.\n\nThe aim of this study is to investigate if the proposed Vivitrol dosing schedule, combined with MET/CBT, is appropriate for subsequent randomized controlled trials in people with CUD. This will be achieved by assessing the safety and effectiveness of 12 weeks open-label treatment with Vivitrol (3 x 4 ml intramuscular injections, 380mg naltrexone) combined with weekly MET/CBT.\n\nSafety will be assessed by monitoring adverse events during the 12 week treatment period, and up to 3 months follow-up. Effectiveness will be assessed after 12 weeks of treatment and at 3 month follow-up using: (1) seven-day point prevalence cannabis abstinence, (2) percentage of days of cannabis use, (3) amount of cannabis use, and (4) effects on withdrawal symptom scores, craving scores and number of urine samples screened positive for cannabis use.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult (18-64) male or female (gender to be analyzed as a covariate)\n* Understand and willing to comply with study requirements and restrictions\n* Willing to use appropriate contraceptive method throughout the study\n* Otherwise healthy as judged by investigator based on medical history, physical exam, vitals, ECG and labs\n* DSM 5 criteria for current CUD\n* Report cannabis as primary drug of abuse\n* Have cannabis positive urine drug screen\n* Treatment seeking cannabis smoker\n\nExclusion Criteria:\n\n* Meets DSM 5 criteria for a current axis I disorder including substance use disorder other than cannabis, nicotine or caffeine dependence.\n* Unstable medical conditions\n* Pregnant or breast-feeding\n* Positive urine drug test for opioids (including methadone, morphine, buprenorphine) or benzodiazepines (unless prescribed) at baseline\n* Any IM gluteal administration 30 days prior to baseline\n* Participation in a clinical trial of a pharmacological agent within 30 days prior to baseline\n* Known intolerance and/or hypersensitivity to naltrexone, carboxymethylcellulose, or polylactide-coglycolide\n* Any finding that, in the view of the principal investigator, would compromise the subject's ability to fulfill the protocol visit schedule or visit requirement (e.g. unadjudicated charges and/or pending parole hearings)"}, 'identificationModule': {'nctId': 'NCT04139668', 'briefTitle': 'Vivitrol Treatment for Cannabis Use Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Centre for Addiction and Mental Health'}, 'officialTitle': 'Vivitrol Associated With Behavioural-Relapse Prevention Strategy as Treatment for Cannabis Use Disorder', 'orgStudyIdInfo': {'id': '048/2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vivitrol + MET/CBT', 'description': 'All participants will receive three 4ml doses of extended-release naltrexone 380mg (Vivitrol), administered by intramuscular injection. Three injections will be administered to each participant; one injection every 4 weeks for 12 weeks of treatment. In addition, all participants will receive weekly Motivational Enhancement Therapy and Cognitive Behavioral Therapy for 12 weeks.', 'interventionNames': ['Drug: Naltrexone 380 MG [Vivitrol]', 'Behavioral: Motivational Enhancement Therapy and Cognitive Behavioral Therapy']}], 'interventions': [{'name': 'Naltrexone 380 MG [Vivitrol]', 'type': 'DRUG', 'otherNames': ['Extended release naltrexone', 'Injectable naltrexone', 'Vivitrol'], 'description': 'Three 4ml intramuscular injections of naltrexone 380mg (Vivitrol) administered over 12 weeks (one injection every 4 weeks)', 'armGroupLabels': ['Vivitrol + MET/CBT']}, {'name': 'Motivational Enhancement Therapy and Cognitive Behavioral Therapy', 'type': 'BEHAVIORAL', 'description': 'Weekly Motivational Enhancement Therapy and Cognitive Behavioral Therapy (MET/CBT), based upon the Brief Counselling for Marijuana Dependence Manual published by the Substance Abuse and Mental Health Services Administration (SAMHSA), for 12 weeks', 'armGroupLabels': ['Vivitrol + MET/CBT']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5S2S1', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Centre for Addiction and Mental Health', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Bernard Le Foll, MD,PhD,MCFP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre for Addiction and Mental Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre for Addiction and Mental Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}