Cannabis Use DisorderPhase 2NCT04139668

Vivitrol Treatment for Cannabis Use Disorder

A Phase 2 study testing Naltrexone 380 MG [Vivitrol] and Motivational Enhancement Therapy and Cognitive Behavioral Therapy in people with Cannabis Use Disorder, run by Centre for Addiction and Mental Health at 1 site in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 64 years
Conditions the study is for: Cannabis Use Disorder
What is being tested?: Naltrexone 380 MG [Vivitrol] and Motivational Enhancement Therapy and Cognitive Behavioral Therapy
Type of treatment: Injection or infusion, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1 participants
Where: 1 siteCanada
Study dates: 9 Jun 2021to 13 Jun 2022
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 64 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Adult (18-64) male or female (gender to be analyzed as a covariate)
Understand and willing to comply with study requirements and restrictions
Willing to use appropriate contraceptive method throughout the study
Otherwise healthy as judged by investigator based on medical history, physical exam, vitals, ECG and labs
DSM 5 criteria for current CUD
Report cannabis as primary drug of abuse
Have cannabis positive urine drug screen
Treatment seeking cannabis smoker

Who cannot join

Meets DSM 5 criteria for a current axis I disorder including substance use disorder other than cannabis, nicotine or caffeine dependence.
Unstable medical conditions
Pregnant or breast-feeding
Positive urine drug test for opioids (including methadone, morphine, buprenorphine) or benzodiazepines (unless prescribed) at baseline
Any IM gluteal administration 30 days prior to baseline
Participation in a clinical trial of a pharmacological agent within 30 days prior to baseline
Known intolerance and/or hypersensitivity to naltrexone, carboxymethylcellulose, or polylactide-coglycolide
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)

Trial locations and contacts

1 site in 1 country.

Canada1 site

Centre for Addiction and Mental Health
Toronto, Ontario, M5S2S1

Other trials in Canada

About this study

Official title: Vivitrol Associated With Behavioural-Relapse Prevention Strategy as Treatment for Cannabis Use Disorder

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.

Read the detailed description

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.

The 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.

Safety 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.

Conditions: Cannabis Use Disorder
Being tested: Naltrexone 380 MG [Vivitrol], Motivational Enhancement Therapy and Cognitive Behavioral Therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Naltrexone 380 MG [Vivitrol]Drug
Also called Extended release naltrexone, Injectable naltrexone, Vivitrol
Three 4ml intramuscular injections of naltrexone 380mg (Vivitrol) administered over 12 weeks (one injection every 4 weeks)
Motivational Enhancement Therapy and Cognitive Behavioral TherapyBehavioural
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

Study groups in NCT04139668
Study group	Role	What they receive
Vivitrol + MET/CBT	Experimental	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. Receives: Drug: Naltrexone 380 MG [Vivitrol]; Behavioral: Motivational Enhancement Therapy and Cognitive Behavioral Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Dropouts Due to Serious Adverse Events
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
Measured: At end of 12 weeks treatment
Dropouts Due to Serious Adverse Events
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
Measured: At 3 months follow-up
Cannabis Abstinence
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.
Measured: At end of 12 weeks treatment
Cannabis Abstinence
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.
Measured: At 3 month follow-up

Secondary outcomes (5)

Days Cannabis Use
Percentage of days of cannabis use. This will be calculated using a self-report timeline follow-back (TLFB) calendar method
Measured: During 12 weeks of treatment and up to 3 month follow-up
Amount Cannabis Use
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
Measured: During 12 weeks of treatment and up to 3 month follow-up
Cannabis Withdrawal
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).
Measured: During 12 weeks of treatment and up to 3 month follow-up
Cannabis Craving
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).
Measured: During 12 weeks of treatment and up to 3 month follow-up
Urine Cannabis Screens
Number of urine samples positive for cannabis use. Urine samples will be collected to perform THC metabolite analysis
Measured: During 12 weeks of treatment and up to 3 month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Jun 202113 Jun 2022

First posted25 Oct 2019
Study start9 Jun 2021
Primary completion28 Oct 2021
Study completion13 Jun 2022

Why it stopped: Funder contract terminated

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Cannabis Use DisorderStudies of the same condition, open and under way.
More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 1 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04139668
Sponsor's protocol ID: 048/2018
Status last verified: Oct 2024
First submitted: 21 Oct 2019
Last updated: 7 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cannabis Use Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Vivitrol Associated With Behavioural-Relapse Prevention Strategy as Treatment for Cannabis Use Disorder
ClinicalTrials.gov ID: NCT04139668
Acronym / sponsor ID: 048/2018
Conditions: Cannabis Use Disorder
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Funder contract terminated
Enrolment: 1 participants (actual)
Lead sponsor: Centre for Addiction and Mental HealthUniversity, hospital or other
Study start: 9 Jun 2021 (actual)
Primary completion: 28 Oct 2021 (actual)
Study completion: 13 Jun 2022 (actual)
First posted: 25 Oct 2019 (actual)
Results: Posted 7 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Vivitrol + MET/CBT	Experimental	Drug: Naltrexone 380 MG [Vivitrol], Behavioral: Motivational Enhancement Therapy and Cognitive Behavioral TherapyAll 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.

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Adult (18-64) male or female (gender to be analyzed as a covariate)
Understand and willing to comply with study requirements and restrictions
Willing to use appropriate contraceptive method throughout the study
Otherwise healthy as judged by investigator based on medical history, physical exam, vitals, ECG and labs
DSM 5 criteria for current CUD

Key exclusion criteria (8 listed)

Meets DSM 5 criteria for a current axis I disorder including substance use disorder other than cannabis, nicotine or caffeine dependence.
Unstable medical conditions
Pregnant or breast-feeding
Positive urine drug test for opioids (including methadone, morphine, buprenorphine) or benzodiazepines (unless prescribed) at baseline
Any IM gluteal administration 30 days prior to baseline

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Naltrexone 380 MG [Vivitrol]Also: Extended release naltrexone, Injectable naltrexone, VivitrolThree 4ml intramuscular injections of naltrexone 380mg (Vivitrol) administered over 12 weeks (one injection every 4 weeks)	Drug	Vivitrol + MET/CBT
Motivational Enhancement Therapy and Cognitive Behavioral TherapyWeekly 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	Behavioural	Vivitrol + MET/CBT

Primary outcome

Dropouts Due to Serious Adverse Events
Time frame: 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
Dropouts Due to Serious Adverse Events
Time frame: 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
Cannabis Abstinence
Time frame: 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.
Cannabis Abstinence
Time frame: 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.

5 secondary outcomes

Days Cannabis Use
Time frame: During 12 weeks of treatment and up to 3 month follow-up
Amount Cannabis Use
Time frame: During 12 weeks of treatment and up to 3 month follow-up
Cannabis Withdrawal
Time frame: During 12 weeks of treatment and up to 3 month follow-up
Cannabis Craving
Time frame: During 12 weeks of treatment and up to 3 month follow-up
Urine Cannabis Screens
Time frame: During 12 weeks of treatment and up to 3 month follow-up

Results and safety

Results posted to the registry on 7 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vivitrol + MET/CBT	1	0

Primary outcome: Dropouts Due to Serious Adverse Events

Time frame: At end of 12 weeks treatment. Count of participants. Unit: Participants

Measure	Vivitrol + MET/CBT n = 1
Value	0

Population analysed: Only 1 participant was enrolled, and this participant withdrew prior to completion at 6 weeks; data are reported up to 6 weeks.

Primary outcome: Dropouts Due to Serious Adverse Events

Time frame: At 3 months follow-up

Population analysed: 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 outcome: Cannabis Abstinence

Time frame: At end of 12 weeks treatment

Population analysed: Only 1 participant was enrolled and this participant withdrew at 6 weeks, so data were not collected for this Outcome Measure.

Primary outcome: Cannabis Abstinence

Time frame: At 3 month follow-up

Population analysed: Only 1 participant was enrolled and this participant withdrew at 6 weeks, so data were not collected for this Outcome Measure.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vivitrol + MET/CBT	0 of 1 (0%)	1 of 1 (100%)	0 of 1

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bernard Le Foll, MD,PhD,MCFP principal investigator

Centre for Addiction and Mental Health

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dropouts Due to Serious Adverse Events (time frame: At end of 12 weeks treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04139668.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.