Vivitrol Treatment for Cannabis Use Disorder

September 24, 2020 updated by: Centre for Addiction and Mental Health

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Ontario
      • Toronto, Ontario, Canada, M5S2S1
        • Centre for Addiction and Mental Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 62 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Three 4ml intramuscular injections of naltrexone 380mg (Vivitrol) administered over 12 weeks (one injection every 4 weeks)
Other Names:
  • Vivitrol
  • Extended release naltrexone
  • Injectable naltrexone
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At end of 12 weeks treatment
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
At 3 months follow-up
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.
At end of 12 weeks treatment
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.
At 3 month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Days cannabis use
Time Frame: 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
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
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
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
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
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
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
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
Number of urine samples positive for cannabis use. Urine samples will be collected to perform THC metabolite analysis
During 12 weeks of treatment and up to 3 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2020

Primary Completion (Anticipated)

February 1, 2021

Study Completion (Anticipated)

February 1, 2021

Study Registration Dates

First Submitted

October 21, 2019

First Submitted That Met QC Criteria

October 23, 2019

First Posted (Actual)

October 25, 2019

Study Record Updates

Last Update Posted (Actual)

September 25, 2020

Last Update Submitted That Met QC Criteria

September 24, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cannabis Use Disorder

Clinical Trials on Naltrexone 380 MG [Vivitrol]

3
Subscribe