Sativex and Behavioral-relapse Prevention Strategy in Cannabis Dependence
Condition: Cannabis Dependence
MeSH terms: Marijuana Abuse
Intervention: Motivational Enhancement/Cognitive Behavioral Therapy; Sativex; Placebo spray
Intervention description: 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).
Intervention MeSH terms: Ethanol; Nabiximols; Dronabinol; Cannabidiol; Peppermint oil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

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.
    

Eligibility 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