Trial · NCT04139668
Vivitrol Treatment for Cannabis Use Disorder
NCT04139668, Phase 2, Terminated, Centre for Addiction and Mental Health; results first posted 2025-02-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Vivitrol Treatment for Cannabis Use Disorder. Trials, record NCT04139668. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04139668
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Vivitrol Treatment for Cannabis Use Disorder
- NCT number
- NCT04139668
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 1 participants, actual
- Lead sponsor
- Centre for Addiction and Mental Health
- Conditions
- Cannabis Use Disorder
- Interventions
- Naltrexone 380 MG [Vivitrol], Motivational Enhancement Therapy and Cognitive Behavioral Therapy
- First posted
- 2019-10-25
- Last updated
- 2025-02-07
- Results first posted
- 2025-02-07
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dropouts Due to Serious Adverse Events | At end of 12 weeks treatment | 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 |
| Primary | Dropouts Due to Serious Adverse Events | At 3 months follow-up | 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 |
| Primary | Cannabis Abstinence | At end of 12 weeks treatment | 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. |
| Primary | Cannabis Abstinence | At 3 month follow-up | 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. |
| Secondary | Days Cannabis Use | During 12 weeks of treatment and up to 3 month follow-up | Percentage of days of cannabis use. This will be calculated using a self-report timeline follow-back (TLFB) calendar method |
| Secondary | Amount Cannabis Use | During 12 weeks of treatment and up to 3 month follow-up | 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 |
| Secondary | Cannabis Withdrawal | During 12 weeks of treatment and up to 3 month follow-up | 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). |
| Secondary | Cannabis Craving | During 12 weeks of treatment and up to 3 month follow-up | 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). |
| Secondary | Urine Cannabis Screens | During 12 weeks of treatment and up to 3 month follow-up | Number of urine samples positive for cannabis use. Urine samples will be collected to perform THC metabolite analysis |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Dropouts Due to Serious Adverse Events | At end of 12 weeks treatment | Only 1 participant was enrolled, and this participant withdrew prior to completion at 6 weeks; data are reported up to 6 weeks. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Dropouts Due to Serious Adverse Events | At 3 months follow-up | 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. | ||
| PRIMARY | Cannabis Abstinence | At end of 12 weeks treatment | Only 1 participant was enrolled and this participant withdrew at 6 weeks, so data were not collected for this Outcome Measure. | ||
| PRIMARY | Cannabis Abstinence | At 3 month follow-up | Only 1 participant was enrolled and this participant withdrew at 6 weeks, so data were not collected for this Outcome Measure. | ||
| SECONDARY | Days Cannabis Use | During 12 weeks of treatment and up to 3 month follow-up | 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/week | NUMBER |
| SECONDARY | Amount Cannabis Use | During 12 weeks of treatment and up to 3 month follow-up | Only 1 participant was enrolled, and this participant withdrew prior to completion at 6 weeks; data are reported up to 6 weeks. | g/week of cannabis | NUMBER |
| SECONDARY | Cannabis Withdrawal | During 12 weeks of treatment and up to 3 month follow-up | Only 1 participant was enrolled, and this participant withdrew prior to completion at 6 weeks; data are reported up to 6 weeks. | score on a scale | NUMBER |
| SECONDARY | Cannabis Craving | During 12 weeks of treatment and up to 3 month follow-up | Only 1 participant was enrolled, and this participant withdrew prior to completion at 6 weeks; data are reported up to 6 weeks. | score on a scale | NUMBER |
| SECONDARY | Urine Cannabis Screens | During 12 weeks of treatment and up to 3 month follow-up | Only 1 participant was enrolled, and this participant withdrew prior to completion at 6 weeks; data are reported up to 6 weeks. | Total number of positive urine samples | NUMBER |
Source ClinicalTrials.gov
Results by group44
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Dropouts Due to Serious Adverse Events | Vivitrol + MET/CBT | 0 | Participants | ||
| Days Cannabis Use | Vivitrol + MET/CBT | Week 1 | 100 | Percentage of days/week | |
| Days Cannabis Use | Vivitrol + MET/CBT | Week 2 | 28.6 | Percentage of days/week | |
| Days Cannabis Use | Vivitrol + MET/CBT | Week 3 | 0 | Percentage of days/week | |
| Days Cannabis Use | Vivitrol + MET/CBT | Week 4 | 0 | Percentage of days/week | |
| Days Cannabis Use | Vivitrol + MET/CBT | Week 5 | 0 | Percentage of days/week | |
| Days Cannabis Use | Vivitrol + MET/CBT | Week 6 | 0 | Percentage of days/week | |
| Amount Cannabis Use | Vivitrol + MET/CBT | Week 1 | 14 | g/week of cannabis | |
| Amount Cannabis Use | Vivitrol + MET/CBT | Week 2 | 6 | g/week of cannabis | |
| Amount Cannabis Use | Vivitrol + MET/CBT | Week 3 | 0 | g/week of cannabis |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vivitrol + MET/CBT | 1 | |
| Overall Study | COMPLETED | Vivitrol + MET/CBT | 0 | |
| Overall Study | NOT COMPLETED | Vivitrol + MET/CBT | 1 |
Source ClinicalTrials.gov
Adverse events5
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Nervous system disorders | Vivitrol + MET/CBT | 1 | 1 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Vivitrol + MET/CBT | 1 | 1 | 1 |
| other | Insomnia | Nervous system disorders | Vivitrol + MET/CBT | 1 | 1 | 1 |
| other | Dizziness | Nervous system disorders | Vivitrol + MET/CBT | 1 | 1 | 1 |
| other | Hair loss | Skin and subcutaneous tissue disorders | Vivitrol + MET/CBT | 1 | 1 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vivitrol + MET/CBT | 0 | 1 |
| Total, other adverse events | Vivitrol + MET/CBT | 1 | 1 |
| Total, serious adverse events | Vivitrol + MET/CBT | 0 | 1 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04139668
GET https://conductscience.org/api/trials/v1/NCT04139668/results?page=2