Trial Outcomes & Findings for Vivitrol Treatment for Cannabis Use Disorder (NCT NCT04139668)
NCT ID: NCT04139668
Last Updated: 2025-02-07
Results Overview
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
TERMINATED
PHASE2
1 participants
At end of 12 weeks treatment
2025-02-07
Participant Flow
Participant milestones
| Measure |
Vivitrol + MET/CBT
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.
Naltrexone 380 MG \[Vivitrol\]: Three 4ml intramuscular injections of naltrexone 380mg (Vivitrol) administered over 12 weeks (one injection every 4 weeks)
Motivational 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
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|---|---|
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Overall Study
STARTED
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1
|
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Overall Study
COMPLETED
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0
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| Measure |
Vivitrol + MET/CBT
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.
Naltrexone 380 MG \[Vivitrol\]: Three 4ml intramuscular injections of naltrexone 380mg (Vivitrol) administered over 12 weeks (one injection every 4 weeks)
Motivational 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
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|---|---|
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Overall Study
Withdrawal by Subject
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1
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Baseline Characteristics
Vivitrol Treatment for Cannabis Use Disorder
Baseline characteristics by cohort
| Measure |
Vivitrol + MET/CBT
n=1 Participants
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.
Naltrexone 380 MG \[Vivitrol\]: Three 4ml intramuscular injections of naltrexone 380mg (Vivitrol) administered over 12 weeks (one injection every 4 weeks)
Motivational 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
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
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1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
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0 Participants
n=5 Participants
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Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: At end of 12 weeks treatmentPopulation: Only 1 participant was enrolled, and this participant withdrew prior to completion at 6 weeks; data are reported up to 6 weeks.
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
Outcome measures
| Measure |
Vivitrol + MET/CBT
n=1 Participants
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.
Naltrexone 380 MG \[Vivitrol\]: Three 4ml intramuscular injections of naltrexone 380mg (Vivitrol) administered over 12 weeks (one injection every 4 weeks)
Motivational 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
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|---|---|
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Dropouts Due to Serious Adverse Events
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0 Participants
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PRIMARY outcome
Timeframe: At 3 months follow-upPopulation: 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.
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
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: At end of 12 weeks treatmentPopulation: Only 1 participant was enrolled and this participant withdrew at 6 weeks, so data were not collected for this Outcome Measure.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: At 3 month follow-upPopulation: Only 1 participant was enrolled and this participant withdrew at 6 weeks, so data were not collected for this Outcome Measure.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: During 12 weeks of treatment and up to 3 month follow-upPopulation: Only 1 participant was enrolled, and this participant withdrew prior to completion at 6 weeks; data are reported up to 6 weeks.
Percentage of days of cannabis use. This will be calculated using a self-report timeline follow-back (TLFB) calendar method
Outcome measures
| Measure |
Vivitrol + MET/CBT
n=1 Participants
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.
Naltrexone 380 MG \[Vivitrol\]: Three 4ml intramuscular injections of naltrexone 380mg (Vivitrol) administered over 12 weeks (one injection every 4 weeks)
Motivational 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
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|---|---|
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Days Cannabis Use
Week 1
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100 Percentage of days/week
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Days Cannabis Use
Week 2
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28.6 Percentage of days/week
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Days Cannabis Use
Week 3
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0 Percentage of days/week
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Days Cannabis Use
Week 4
|
0 Percentage of days/week
|
|
Days Cannabis Use
Week 5
|
0 Percentage of days/week
|
|
Days Cannabis Use
Week 6
|
0 Percentage of days/week
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SECONDARY outcome
Timeframe: During 12 weeks of treatment and up to 3 month follow-upPopulation: Only 1 participant was enrolled, and this participant withdrew prior to completion at 6 weeks; data are reported up to 6 weeks.
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
Outcome measures
| Measure |
Vivitrol + MET/CBT
n=1 Participants
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.
Naltrexone 380 MG \[Vivitrol\]: Three 4ml intramuscular injections of naltrexone 380mg (Vivitrol) administered over 12 weeks (one injection every 4 weeks)
Motivational 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
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|---|---|
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Amount Cannabis Use
Week 1
|
14 g/week of cannabis
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Amount Cannabis Use
Week 2
|
6 g/week of cannabis
|
|
Amount Cannabis Use
Week 3
|
0 g/week of cannabis
|
|
Amount Cannabis Use
Week 4
|
0 g/week of cannabis
|
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Amount Cannabis Use
Week 5
|
0 g/week of cannabis
|
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Amount Cannabis Use
Week 6
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0 g/week of cannabis
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SECONDARY outcome
Timeframe: During 12 weeks of treatment and up to 3 month follow-upPopulation: Only 1 participant was enrolled, and this participant withdrew prior to completion at 6 weeks; data are reported up to 6 weeks.
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).
Outcome measures
| Measure |
Vivitrol + MET/CBT
n=1 Participants
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.
Naltrexone 380 MG \[Vivitrol\]: Three 4ml intramuscular injections of naltrexone 380mg (Vivitrol) administered over 12 weeks (one injection every 4 weeks)
Motivational 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
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|---|---|
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Cannabis Withdrawal
Week 1
|
4 score on a scale
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Cannabis Withdrawal
Week 2
|
4 score on a scale
|
|
Cannabis Withdrawal
Week 3
|
7 score on a scale
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Cannabis Withdrawal
Week 4
|
13 score on a scale
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Cannabis Withdrawal
Week 5
|
9 score on a scale
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Cannabis Withdrawal
Week 6
|
9 score on a scale
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SECONDARY outcome
Timeframe: During 12 weeks of treatment and up to 3 month follow-upPopulation: Only 1 participant was enrolled, and this participant withdrew prior to completion at 6 weeks; data are reported up to 6 weeks.
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).
Outcome measures
| Measure |
Vivitrol + MET/CBT
n=1 Participants
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.
Naltrexone 380 MG \[Vivitrol\]: Three 4ml intramuscular injections of naltrexone 380mg (Vivitrol) administered over 12 weeks (one injection every 4 weeks)
Motivational 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
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|---|---|
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Cannabis Craving
Week 1 Compulsivity
|
3 score on a scale
|
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Cannabis Craving
Week 1 Emotionality
|
3 score on a scale
|
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Cannabis Craving
Week 1 Expectancy
|
5 score on a scale
|
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Cannabis Craving
Week 1 Purposefulness
|
3 score on a scale
|
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Cannabis Craving
Week 2 Compulsivity
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3 score on a scale
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Cannabis Craving
Week 2 Emotionality
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3 score on a scale
|
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Cannabis Craving
Week 2 Expectancy
|
3 score on a scale
|
|
Cannabis Craving
Week 2 Purposefulness
|
3 score on a scale
|
|
Cannabis Craving
Week 3 Compulsivity
|
3 score on a scale
|
|
Cannabis Craving
Week 3 Emotionality
|
3 score on a scale
|
|
Cannabis Craving
Week 3 Expectancy
|
3 score on a scale
|
|
Cannabis Craving
Week 3 Purposefulness
|
3 score on a scale
|
|
Cannabis Craving
Week 4 Compulsivity
|
3 score on a scale
|
|
Cannabis Craving
Week 4 Emotionality
|
3 score on a scale
|
|
Cannabis Craving
Week 4 Expectancy
|
3 score on a scale
|
|
Cannabis Craving
Week 4 Purposefulness
|
3 score on a scale
|
|
Cannabis Craving
Week 5 Compulsivity
|
3 score on a scale
|
|
Cannabis Craving
Week 5 Emotionality
|
3 score on a scale
|
|
Cannabis Craving
Week 5 Expectancy
|
3 score on a scale
|
|
Cannabis Craving
Week 5 Purposefulness
|
3 score on a scale
|
|
Cannabis Craving
Week 6 Compulsivity
|
3 score on a scale
|
|
Cannabis Craving
Week 6 Emotionality
|
3 score on a scale
|
|
Cannabis Craving
Week 6 Expectancy
|
3 score on a scale
|
|
Cannabis Craving
Week 6 Purposefulness
|
3 score on a scale
|
SECONDARY outcome
Timeframe: During 12 weeks of treatment and up to 3 month follow-upPopulation: Only 1 participant was enrolled, and this participant withdrew prior to completion at 6 weeks; data are reported up to 6 weeks.
Number of urine samples positive for cannabis use. Urine samples will be collected to perform THC metabolite analysis
Outcome measures
| Measure |
Vivitrol + MET/CBT
n=1 Participants
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.
Naltrexone 380 MG \[Vivitrol\]: Three 4ml intramuscular injections of naltrexone 380mg (Vivitrol) administered over 12 weeks (one injection every 4 weeks)
Motivational 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
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|---|---|
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Urine Cannabis Screens
|
6 Total number of positive urine samples
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Adverse Events
Vivitrol + MET/CBT
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Vivitrol + MET/CBT
n=1 participants at risk
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.
Naltrexone 380 MG \[Vivitrol\]: Three 4ml intramuscular injections of naltrexone 380mg (Vivitrol) administered over 12 weeks (one injection every 4 weeks)
Motivational 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
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|---|---|
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Nervous system disorders
Nausea
|
100.0%
1/1 • Number of events 1 • 6 weeks
Use of SAFTEE guidelines to capture AEs at every visit following consent
|
|
Gastrointestinal disorders
Abdominal pain
|
100.0%
1/1 • Number of events 1 • 6 weeks
Use of SAFTEE guidelines to capture AEs at every visit following consent
|
|
Nervous system disorders
Insomnia
|
100.0%
1/1 • Number of events 1 • 6 weeks
Use of SAFTEE guidelines to capture AEs at every visit following consent
|
|
Nervous system disorders
Dizziness
|
100.0%
1/1 • Number of events 1 • 6 weeks
Use of SAFTEE guidelines to capture AEs at every visit following consent
|
|
Skin and subcutaneous tissue disorders
Hair loss
|
100.0%
1/1 • Number of events 1 • 6 weeks
Use of SAFTEE guidelines to capture AEs at every visit following consent
|
Additional Information
Dr. Bernard Le Foll
Centre for Addiction and Mental Health
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place