- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04139668
Vivitrol Treatment for Cannabis Use Disorder
Vivitrol Associated With Behavioural-Relapse Prevention Strategy as Treatment for Cannabis Use Disorder
Study Overview
Status
Conditions
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
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Bernard Le Foll, MD,PhD,MCFP
- Phone Number: 33111 4165358501
- Email: Bernard.LeFoll@camh.ca
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5S2S1
- Centre for Addiction and Mental Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
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
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 048/2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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
-
The University of Tennessee, KnoxvilleColorado State UniversityActive, not recruitingCannabis Use Disorder, Mild | Cannabis Use Disorder, Moderate | Cannabis Use Disorder, SevereUnited States
-
Medical University of South CarolinaNational Institute on Drug Abuse (NIDA)RecruitingCannabis Use Disorder, Mild | Cannabis Use Disorder, Moderate | Cannabis Use Disorder, SevereUnited States
-
Medical University of South CarolinaNational Institute on Drug Abuse (NIDA)RecruitingBipolar Disorder | Cannabis Use | Bipolar I Disorder | Cannabis Use Disorder, Mild | Cannabis Use Disorder, Moderate | Cannabis Use Disorder, Severe | Bipolar II Disorder | Schizoaffective Disorder, Bipolar TypeUnited States
-
Monash UniversityTurning PointCompletedCannabis Use Disorder, Moderate | Cannabis Use Disorder, SevereAustralia
-
Oregon Research InstituteCompletedCannabis Use Disorder, Mild | Cannabis Use Disorder, ModerateUnited States
-
McMaster UniversityCenter for Medicinal Cannabis ResearchNot yet recruitingCannabis Use Disorder, Moderate | Cannabis Use Disorder, Severe
-
Ellen HerbstTobacco Related Disease Research ProgramRecruitingTobacco Use Disorder | Cannabis Use | Drug Use DisorderUnited States
-
Elias DakwarRecruitingAddiction | Cannabis Dependence | Cannabis Use | Substance Abuse | Cannabis Abuse | Cannabis Use DisorderUnited States
-
Dartmouth-Hitchcock Medical CenterNational Institute on Drug Abuse (NIDA)Completed
-
The Scripps Research InstituteNational Institute on Drug Abuse (NIDA)CompletedAlcohol Dependence | Cannabis Dependence | Alcohol Use Disorder | Cannabis Use DisorderUnited States
Clinical Trials on Naltrexone 380 MG [Vivitrol]
-
Alkermes, Inc.Completed
-
Alkermes, Inc.Completed
-
Alkermes, Inc.Terminated
-
Alkermes, Inc.CompletedOpiate DependenceUnited States
-
Alkermes, Inc.Completed
-
Alkermes, Inc.Completed
-
Go Medical Industries Pty LtdNational Institute on Drug Abuse (NIDA); Columbia University; New York State... and other collaboratorsCompleted
-
University of PennsylvaniaCompletedPrescription Opiate/Medication DependenceUnited States
-
Alkermes, Inc.CompletedOpiate DependenceRussian Federation