Sativex and Behavioral-relapse Prevention Strategy in Cannabis Dependence
Condition: Cannabis Dependence
MeSH terms: Marijuana Abuse
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      In the pilot study subjects will be treated with SATIVEX® (THC/cannabidiol combination in a
      buccal spray) using the same approach as outlined below for the randomized controlled trial.
      In the twelve-week, double-blind, placebo-controlled study visits will occur weekly during
      the medication phase of the study. The medication will be self-titrated over three weeks and
      a target quit date will be set up at Day 21. There will be a total of 12 weeks of drug
      exposure. Throughout these 12-weeks, 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) in
      accordance with the intervention practices shown to be effective in treatment of cannabis
      dependence. The intervention will be adapted from the Brief Counselling for Marijuana
      Dependence manual published by the Substance Abuse and Mental Health Services Administration
      (SAMHSA). At each study visit, vital signs and self-report ratings will be collected. In
      addition, the subjects will have to come daily to the centre to assess medication usage and
      will be asked to provide urine sample (two times weekly) and blood sample weekly. As there
      may be compliance issues, a contingency management approach will be also implemented.
    

Intervention name(s): Motivational Enhancement/Cognitive Behavioral Therapy; Sativex; Placebo spray
Intervention type(s): Behavioral; Drug; Drug
Intervention description(s): All participants will receive a combination of pharmacotherapy (Sativex or Placebo) associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy.; Study subjects will gradually increase the maximal allowed dose of Sativex starting at five sprays per day for the first two days and increasing of five sprays per day until reaching the max number of 42 sprays maximal per day at end of week 2 (Day 11). The target quit date will be set at Day 21 (but subjects will be allowed to stop using cannabis before if they are willing and able to). The medication treatment phase will then be continued for an additional 9 weeks (the last week will be a reduction phase with the use of Spray that will be decreased by 50% to avoid abrupt withdrawal). Then exposure to medications will be stopped (so there will be a total of 12 weeks medication treatment exposure).; Study subjects will gradually increase the maximal allowed dose of Placebo starting at five sprays per day for the first two days and increasing of five sprays per day until reaching the max number of 42 sprays maximal per day at end of week 2 (Day 11). The target quit date will be set at Day 21 (but subjects will be allowed to stop using cannabis before if they are willing and able to). The Placebo treatment phase will then be continued for an additional 9 weeks (the last week will be a reduction phase with the use of Placebo Spray that will be decreased by 50%). Then exposure to Placebo will be stopped (so there will be a total of 12 weeks Placebo treatment exposure).
Other intervention name(s): delta-9-tetrahydrocannabinol and cannabidiol; Ethanol,propylene glycol,and peppermint oil with colors
Intervention MeSH terms: Ethanol; Nabiximols; Dronabinol; Cannabidiol; Peppermint oil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment