Vivitrol Treatment for Cannabis Use Disorder

Cannabis Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04139668
• Other study ID #: 048/2018
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: September 2020
• Est. completion date: February 2021

Study information

• Verified date: September 2020
• Source: Centre for Addiction and Mental Health
• Contact: Bernard Le Foll, MD,PhD,MCFP
• Phone: 4165358501
• Email: Bernard.LeFoll[@]camh.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: February 2021
• Est. primary completion date: February 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cannabis Use Disorder
• Marijuana Abuse

Intervention

Drug:
• Naltrexone 380 MG [Vivitrol]
Three 4ml intramuscular injections of naltrexone 380mg (Vivitrol) administered over 12 weeks (one injection every 4 weeks)

Behavioral:
• Motivational Enhancement Therapy and Cognitive Behavioral Therapy
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

Locations

Country	Name	City	State
Canada	Centre for Addiction and Mental Health	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Days cannabis use	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
Secondary	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	During 12 weeks of treatment and up to 3 month follow-up
Secondary	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	During 12 weeks of treatment and up to 3 month follow-up
Secondary	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	During 12 weeks of treatment and up to 3 month follow-up
Secondary	Urine cannabis screens	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