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Vivitrol Treatment for Cannabis Use Disorder

Primary Purpose

Cannabis Use Disorder

Status
Unknown status
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Naltrexone 380 MG [Vivitrol]
Motivational Enhancement Therapy and Cognitive Behavioral Therapy
Sponsored by
Centre for Addiction and Mental Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cannabis Use Disorder

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Centre for Addiction and Mental Health

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vivitrol + MET/CBT

Arm Description

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.

Outcomes

Primary Outcome Measures

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
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
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.
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.

Secondary Outcome Measures

Days cannabis use
Percentage of days of cannabis use. This will be calculated using a self-report timeline follow-back (TLFB) calendar method
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
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
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
Urine cannabis screens
Number of urine samples positive for cannabis use. Urine samples will be collected to perform THC metabolite analysis

Full Information

First Posted
October 21, 2019
Last Updated
September 24, 2020
Sponsor
Centre for Addiction and Mental Health
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1. Study Identification

Unique Protocol Identification Number
NCT04139668
Brief Title
Vivitrol Treatment for Cannabis Use Disorder
Official Title
Vivitrol Associated With Behavioural-Relapse Prevention Strategy as Treatment for Cannabis Use Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 2020 (Anticipated)
Primary Completion Date
February 2021 (Anticipated)
Study Completion Date
February 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre for Addiction and Mental Health

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Use Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vivitrol + MET/CBT
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Naltrexone 380 MG [Vivitrol]
Other Intervention Name(s)
Extended release naltrexone, Injectable naltrexone, Vivitrol
Intervention Description
Three 4ml intramuscular injections of naltrexone 380mg (Vivitrol) administered over 12 weeks (one injection every 4 weeks)
Intervention Type
Behavioral
Intervention Name(s)
Motivational Enhancement Therapy and Cognitive Behavioral Therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Dropouts due to serious adverse events
Description
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
Time Frame
At end of 12 weeks treatment
Title
Dropouts due to serious adverse events
Description
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
Time Frame
At 3 months follow-up
Title
Cannabis abstinence
Description
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.
Time Frame
At end of 12 weeks treatment
Title
Cannabis abstinence
Description
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.
Time Frame
At 3 month follow-up
Secondary Outcome Measure Information:
Title
Days cannabis use
Description
Percentage of days of cannabis use. This will be calculated using a self-report timeline follow-back (TLFB) calendar method
Time Frame
During 12 weeks of treatment and up to 3 month follow-up
Title
Amount cannabis use
Description
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
Time Frame
During 12 weeks of treatment and up to 3 month follow-up
Title
Cannabis withdrawal
Description
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
Time Frame
During 12 weeks of treatment and up to 3 month follow-up
Title
Cannabis craving
Description
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
Time Frame
During 12 weeks of treatment and up to 3 month follow-up
Title
Urine cannabis screens
Description
Number of urine samples positive for cannabis use. Urine samples will be collected to perform THC metabolite analysis
Time Frame
During 12 weeks of treatment and up to 3 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bernard Le Foll, MD,PhD,MCFP
Phone
4165358501
Ext
33111
Email
Bernard.LeFoll@camh.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernard Le Foll, MD,PhD,MCFP
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S2S1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Vivitrol Treatment for Cannabis Use Disorder

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