Fixed or Self-Titrated Dosages of Sativex on Cannabis Users
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Purpose
The purpose of this study is to to demonstrate the feasibility and tolerability of the use of Sativex in cannabis dependent individuals and to assess the effects of fixed or self titrated dosages of SATIVEX® (Δ9-tetrahydrocannabinol /cannabidiol combination in a buccal spray) on withdrawal symptoms, craving scores and cannabis consumption during the study period.
| Condition | Intervention |
|---|---|
|
Cannabis Dependence |
Drug: Sativex Drug: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Effects of Fixed or Self-Titrated Dosages of Sativex on Cannabis Users |
- Feasibility [ Time Frame: eight weeks ] [ Designated as safety issue: No ]Feasibility will be assessed by analysing how many participants can be recruited into the study with a period of one year.
- Tolerability of Sativex in cannabis dependent participants [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]To assess what percentage of the included subjects will complete the full experimental phase
| Estimated Enrollment: | 10 |
| Study Start Date: | February 2013 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Fixed dose Sativex
Participants will be requested to take a fixed dose of Sativex during this condition (40 sprays per day)
|
Drug: Sativex
Subjects will participate in each of 8 conditions, lasting 5 weekdays each (an ABACADAE study design); four smoke as usual conditions (SAU) and four cannabis abstinence conditions. During each abstinence condition (B, C, D, E conditions), subjects will be allocated to one conditions including self-titration of placebo, fixed dose of placebo, self-titration of SATIVEX (up to a max of 40 sprays per day, equal to 108mg THC) or fixed dose of SATIVEX (40 sprays per day). Each medication phase will be followed by a washout period where individuals will be requested to smoke cannabis as usual (A condition). The experimental conditions will be: type of SATIVEX® spray used (active vs placebo), and titration regimen (fixed or self-titrated).
|
|
Experimental: Self-titrated Sativex
Participants will be requested to self-titrate dosages of Sativex (up to 40 sprays per day)
|
Drug: Sativex
Subjects will participate in each of 8 conditions, lasting 5 weekdays each (an ABACADAE study design); four smoke as usual conditions (SAU) and four cannabis abstinence conditions. During each abstinence condition (B, C, D, E conditions), subjects will be allocated to one conditions including self-titration of placebo, fixed dose of placebo, self-titration of SATIVEX (up to a max of 40 sprays per day, equal to 108mg THC) or fixed dose of SATIVEX (40 sprays per day). Each medication phase will be followed by a washout period where individuals will be requested to smoke cannabis as usual (A condition). The experimental conditions will be: type of SATIVEX® spray used (active vs placebo), and titration regimen (fixed or self-titrated).
|
|
Placebo Comparator: Fixed dose placebo
Participants will be requested to administer a fixed dose of placebo daily (40 sprays per day)
|
Drug: Placebo |
|
Placebo Comparator: Self-titrated placebo
Participants will be requested to self-titrate dosages of placebo spray (up to 40 sprays per day)
|
Drug: Placebo |
Detailed Description:
This will be a one year pilot/feasibility study, assessing the effects of fixed or self titrated dosages of SATIVEX® (Δ9-tetrahydrocannabinol /cannabidiol combination in a buccal spray) on withdrawal from cannabis and craving among cannabis dependent subjects. Subjects in this study will undergo an 8-week double-blind, placebo-controlled trial. Subjects will be regular cannabis-users who are not currently seeking treatment for cannabis dependence. Subjects will participate in each of 8 conditions, lasting 5 weekdays each (an ABACADAE study design); four smoke as usual conditions (SAU) and four cannabis abstinence conditions. During each abstinence condition (B, C, D, E conditions), subjects will be allocated to one conditions including self-titration of placebo, fixed dose of placebo, self-titration of SATIVEX (up to a max of 40 sprays per day, equal to 108mg THC) or fixed dose of SATIVEX (40 sprays per day). Each medication phase will be followed by a washout period where individuals will be requested to smoke cannabis as usual (A condition). The experimental conditions will be: type of SATIVEX® spray used (active vs placebo), and titration regimen (fixed or self-titrated). This pilot study will allow us to demonstrate the feasibility of our approach and to determine the sample size to use secondarily for a larger study. Our ultimate goal is to determine optimal conditions to use for a subsequent randomized controlled trial assessing the efficacy of SATIVEX® in treatment of Cannabis dependence among treatment-seeking subjects.
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- age 18-50
- current cannabis dependence
- cannabis as primary drug of abuse
- frequent cannabis use (i.e., at least 5 days per week)
- have experienced at least 2 withdrawal symptoms during previous cessation periods
- cannabis use not for medical purposes (i.e., not a government-licensed medical cannabis user)
- not seeking treatment for cannabis dependence
- willingness to participate in study protocol
Exclusion Criteria:
- meet criteria for any psychiatric disorder requiring psychiatric intervention
- have a history of seizures; c)have known sensitivity to Dronabinol, Cannabidiol, Propylene glycole, Ethanol or peppermint oil (used in Sativex buccal spray
- suffer from an unstable medical condition
- currently have physical dependence on any other drugs (excluding nicotine) that would require medical detoxification
- currently taking psychotropic medication with benefit for any other illness than treatment of insomnia
- pregnant or breast-feeding
- hold a job that involves operating heavy machinery
- currently seeking treatment for cannabis-related problems
- family history of psychotic symptoms
Contacts and Locations| Contact: Bernard Le Foll, MD PhD | 4165358501 ext 4772 | bernard.lefoll@camh.ca |
| Canada, Ontario | |
| Centre for Addiction and Mental Health | Recruiting |
| Toronto, Ontario, Canada, M5S 2S1 | |
| Contact: Bernard Le Foll, MD, PhD 416-535-8501 ext 4772 bernard.lefoll@camh.ca | |
| Contact: Islam Gamaleddin, MD, PhD 416-535-8501 ext 6724 islam.gamaleddin@camh.ca | |
| Sub-Investigator: Benedikt Fischer, PhD | |
| Sub-Investigator: Peter Selby, MD | |
| Sub-Investigator: Jurgen Rehm, PhD | |
| Principal Investigator: Bernard Le Foll, MD, PhD | |
| Principal Investigator: | Bernard Le Foll | 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: | NCT01748799 History of Changes |
| Other Study ID Numbers: | 103/2011, 243152 |
| Study First Received: | December 8, 2012 |
| Last Updated: | February 28, 2013 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Centre for Addiction and Mental Health:
|
Cannabis dependence Sativex |
Additional relevant MeSH terms:
|
Marijuana Abuse Substance-Related Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 16, 2013