Sativex and Behavioral-relapse Prevention Strategy in Cannabis Dependence

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is assess Sativex as a treatment for Cannabis dependence. Initially a pilot study will be conducted in five subjects seeking treatment for cannabis dependence to ensure that our planned self-titration regimen is appropriate using Sativex. This phase will be open label, with no placebo control. Then, there will be a twelve-week, double-blind, placebo-controlled study in male and female subjects seeking treatment for cannabis dependence (n=40). All participants will receive a combination of pharmacotherapy (Sativex Spray or Placebo Spray) associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy (MET/CBT). The subjects will have to come daily to the centre to assess usage of medication. Following the medication phase, participants will have a follow-up weekly for another four weeks and then monthly until the 6 month follow up visit after the target quit date. The investigators are planning to enroll 45 subjects over the two-year period.

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

Details

• Lead Sponsor: Centre for Addiction and Mental Health
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Cannabidiol; Dronabinol; Ethanol; Nabiximols; Peppermint oil

Criteria

Inclusion Criteria:

• Adult 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-IV criteria for current marijuana dependence

• Report marijuana as primary drug of abuse

• Report using marijuana at least 5 days a week for at least one month

• Have marijuana positive urine drug screen

• Treatment seeking cannabis smoker

• Smoke less than or equal to the equivalent of 4 joints per day (or four grams per day if participants smokes cannabis in other forms)

Exclusion Criteria:

• Meets DSM-IV criteria for a current axis I disorder including substance use disorder other than cannabis, nicotine or caffeine dependence.

• First-degree relative with schizophrenia

• History of seizures

• History of cardiovascular disease

• History of pulmonary disease such as asthma, COPD

• Clinically significant pathology in oral cavity and poor oral hygiene

• Known sensitivity to dronabinol, cannabidiol, propylene glycole, ethanol or peppermint oil (used in SATIVEX® buccal spray)

• Unstable medical conditions

• Pregnant or breast-feeding

• Currently taking psychotropic medication with benefit for any other illness than treatment of insomnia,

• Holding a job that involves driving, operating heavy machines