Vivitrol Treatment for Cannabis Use Disorder

NCT04139668 | Terminated Phase 2 Results

• 1 other identifier: 048/2018
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Cannabis Use Disorder

Outcome Measures

Primary Outcomes (4)

• 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

  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

  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.

  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.

  At 3 month follow-up

Secondary Outcomes (5)

• Days Cannabis Use

  During 12 weeks of treatment and up to 3 month follow-up

• Amount Cannabis Use

  During 12 weeks of treatment and up to 3 month follow-up

• Cannabis Withdrawal

  During 12 weeks of treatment and up to 3 month follow-up

• Cannabis Craving

  During 12 weeks of treatment and up to 3 month follow-up

• Urine Cannabis Screens

  During 12 weeks of treatment and up to 3 month follow-up

Study Arms (1)

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.

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

Interventions

Naltrexone 380 MG [Vivitrol] DRUG

Three 4ml intramuscular injections of naltrexone 380mg (Vivitrol) administered over 12 weeks (one injection every 4 weeks)

Also known as: Extended release naltrexone, Injectable naltrexone, Vivitrol

Vivitrol + MET/CBT

Motivational Enhancement Therapy and Cognitive Behavioral Therapy BEHAVIORAL

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

Vivitrol + MET/CBT

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5S2S1, Canada

Location

MeSH Terms

Interventions

Naltrexone; vivitrol; Motivational Interviewing; Cognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services; Behavior Therapy; Psychotherapy

Results Point of Contact

• Title: Dr. Bernard Le Foll
• Organization: Centre for Addiction and Mental Health

bernard.lefoll@camh.ca

416-535-8501

Study Officials

• Bernard Le Foll, MD,PhD,MCFP

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2019
• First Posted: October 25, 2019
• Study Start: June 9, 2021
• Primary Completion: October 28, 2021
• Study Completion: June 13, 2022
• Last Updated: February 7, 2025
• Results First Posted: February 7, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)