Sativex and Behavioral-relapse Prevention Strategy in Cannabis Dependence
Status:
Completed
Trial end date:
2015-11-01
Target enrollment:
Participant gender:
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.