Vivitrol Treatment for Cannabis Use Disorder

• Status: Not yet recruiting
• Trial end date: 2021-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre for Addiction and Mental Health
• Treatments: Naltrexone

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)