Vivitrol Treatment for Cannabis Use Disorder

Launched by CENTRE FOR ADDICTION AND MENTAL HEALTH · Oct 23, 2019

Keywords

ClinConnect Summary

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, ...

Gender

ALL

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)