Sativex and Behavioral-relapse Prevention Strategy in Cannabis Dependence
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cannabis Dependence |
Behavioral: Motivational Enhancement Therapy and Cognitive Beh. Therapy Drug: Sativex Drug: Placebo spray |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Sativex Associated With Behavioral-relapse Prevention Strategy as Treatment for Cannabis Dependence |
- Tolerability and efficacy of intervention [ Time Frame: six months ] [ Designated as safety issue: No ]Assessment of tolerability and efficacy will be assessed by determining number of subjects that withdrawal from the study due to SAEs and seven day point prevalence cannabis abstinence one week after medication phase and 6mo follow-up, respectively.
- Cannabis use [ Time Frame: six months ] [ Designated as safety issue: No ]Percentage of days cannabis use and amount of cannabis used over the study duration until 6mo follow-up and number of urine/blood samples screened as positive will be assessed.
- Withdrawal [ Time Frame: six months ] [ Designated as safety issue: No ]Effect of Sativex on withdrawal symptom scores will be assessed
- Cannabis Craving [ Time Frame: six months ] [ Designated as safety issue: No ]Effect of Sativex on cannabis craving will be assessed
| Estimated Enrollment: | 45 |
| Study Start Date: | March 2013 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Sativex
Intervention consist on Sativex Spray (Δ9-tetrahydrocannabinol/cannabidiol). Study subjects will be randomized in blocks of five to one of the two groups (Sativex vs. placebo) in a double blind manner. There will be a gradual increase of the maximal allowed dose 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 per day at the end of week 2. There will be a total of 12 weeks of drug exposure. 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.
|
Behavioral: Motivational Enhancement Therapy and Cognitive Beh. Therapy
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.
Drug: Sativex
|
|
Placebo Comparator: Placebo spray
Participants will receive a combination of pharmacotherapy (Sativex or Placebo) associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy
|
Behavioral: Motivational Enhancement Therapy and Cognitive Beh. Therapy
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.
Drug: Placebo spray
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Bernard Le Foll, MD PhD | 4165358501 | bernard_lefoll@camh.net |
| Canada, Ontario | |
| Centre for Addiction and Mental Health | Recruiting |
| Toronto, Ontario, Canada, M5S 2S1 | |
| Contact: Bernard Le Foll, MD PhD 4165358501 bernard_lefoll@camh.net | |
| Sub-Investigator: Peter Selby, MD | |
| Sub-Investigator: Jurgen Rehm, PhD | |
| Sub-Investigator: Marilyn Huestis, PhD | |
| Sub-Investigator: Benedikt Fischer, PhD | |
| Sub-Investigator: Lena Quilty, PhD | |
| Principal Investigator: Bernard Le Foll, MD, PhD | |
| Principal Investigator: | Bernard Le Foll, MD, PhD | Centre for Addiction and Mental Health |
More Information
Additional Information:
No publications provided
| Responsible Party: | Bernard Le Foll, Head, Translational Addiction Research Laboratory, Centre for Addiction and Mental Health |
| ClinicalTrials.gov Identifier: | NCT01747850 History of Changes |
| Other Study ID Numbers: | 144/2011, R21DA031906 |
| Study First Received: | December 7, 2012 |
| Last Updated: | March 5, 2013 |
| Health Authority: | Canada: Health Canada |
Additional relevant MeSH terms:
|
Marijuana Abuse Substance-Related Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 22, 2013