Sativex and Behavioral-relapse Prevention Strategy in Cannabis Dependence
Sativex Associated With Behavioral-relapse Prevention Strategy as Treatment for Cannabis Dependence
2 other identifiers
interventional
45
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 7, 2012
CompletedFirst Posted
Study publicly available on registry
December 12, 2012
CompletedStudy Start
First participant enrolled
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedResults Posted
Study results publicly available
October 2, 2017
CompletedOctober 2, 2017
July 1, 2017
2.7 years
December 7, 2012
January 18, 2017
August 14, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Tolerability
Assessment of tolerability will be determined by the number of subjects that withdrawal from the study due to SAEs.
six months
Secondary Outcomes (4)
Cannabis Use (in Days)
six months
Withdrawal
six months
Cannabis Craving
six months
Cannabis Use (Grams)
six months
Study Arms (3)
Sativex
EXPERIMENTALIntervention consist on Sativex Spray (Δ9-tetrahydrocannabinol/cannabidiol). Study subjects will be randomized in blocks of ten 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/Cognitive Behavioral Therapy.
Placebo spray
PLACEBO COMPARATORParticipants will receive a combination of Placebo spray associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy
Pilot Study
EXPERIMENTALThe first five subjects will be treatment-seekers that fit our inclusion/exclusion criteria and that will be treated open-label. These subjects will be instructed to use the Sativex Spray according to the induction schedule provided above. These first subjects will allow us to determine if our schedule for dosing is appropriate for the subsequent phase of the study.
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre for Addiction and Mental Health
Toronto, Ontario, M5S 2S1, Canada
Related Publications (1)
Wang R, Trigo JM, Le Foll B. Effects of sub-chronic nabiximols on biological markers of individuals undergoing a clinical trial for the treatment of cannabis use disorder. Am J Transl Res. 2023 Aug 15;15(8):5228-5238. eCollection 2023.
PMID: 37692969DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Jose Trigo
- Organization
- CAMH
Study Officials
- PRINCIPAL INVESTIGATOR
Bernard Le Foll, MD, PhD
Centre for Addiction and Mental Health
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head, Translational Addiction Research Laboratory
Study Record Dates
First Submitted
December 7, 2012
First Posted
December 12, 2012
Study Start
March 1, 2013
Primary Completion
November 1, 2015
Study Completion
November 1, 2015
Last Updated
October 2, 2017
Results First Posted
October 2, 2017
Record last verified: 2017-07
Data Sharing
- IPD Sharing
- Will not share