Phase 2
N=45
Sativex and Behavioral-relapse Prevention Strategy in Cannabis Dependence
Cannabis Dependence
Bottom Line
View on ClinicalTrials.gov: NCT01747850 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Oct 2017
Primary outcome: Primary: Tolerability — 0; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Motivational Enhancement/Cognitive Behavioral Therapy (Behavioral); Sativex (Drug); Placebo spray (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Centre for Addiction and Mental Health
- Primary completion
- Nov 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tolerability |
0; 0; 0 | — |
| SECONDARY Cannabis Use (in Days) |
42.9; 47.1; 48.3 | — |
| SECONDARY Withdrawal |
5.0; 5.1; 2.7 | — |
| SECONDARY Cannabis Craving |
8.2; 9.6; 9.5 | — |
| SECONDARY Cannabis Use (Grams) |
2.3; 3.5; 1.6 | — |
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
Data sourced from ClinicalTrials.gov (NCT01747850). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.