Vivitrol Treatment for Cannabis Use Disorder

Phase 2

Terminated

Conditions: Cannabis Use Disorder

Interventions: Drug: Naltrexone 380 MG [Vivitrol]
Behavioral: Motivational Enhancement Therapy and Cognitive Behavioral Therapy

Registration Number: NCT04139668

Lead Sponsor: Centre for Addiction and Mental Health

Brief Summary: 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.

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 1

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vivitrol + MET/CBT	Motivational Enhancement Therapy and Cognitive Behavioral Therapy	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.
Vivitrol + MET/CBT	Naltrexone 380 MG [Vivitrol]	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.

Primary Outcome Measures

Name	Time	Method
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
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 Outcome Measures

Name	Time	Method
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
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
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).
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).
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

Trial Locations

Locations (1): Centre for Addiction and Mental Health
🇨🇦
Toronto, Ontario, Canada
Centre for Addiction and Mental Health
🇨🇦Toronto, Ontario, Canada