Clinical trial NCT01748799
Conditions: Cannabis Dependence
Keywords: Cannabis dependence Sativex
Sponsor: Centre for Addiction and Mental Health
Start date: 2013-02-01; Completion date: 2014-09-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
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.

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 condition 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.

Arms: arm 1: Self-titrated placebo - Self-titrated Sativex - Fixed dose Sativex - Fixed dose placebo arm 2: Fixed dose placebo - Fixed dose Sativex - Self-titrated Sativex - Self-titrated placebo arm 3: Fixed dose placebo - Fixed dose Sativex - Self-titrated placebo - Self-titrated Sativex arm 4: Fixed dose Sativex - Fixed dose placebo - Self-titrated placebo - Self-titrated Sativex arm 5: Self-titrated Sativex - Self-titrated placebo - Fixed dose Sativex - Fixed dose placebo arm 6: Self-titrated Sativex - Self-titrated placebo - Fixed dose placebo - Fixed dose Sativex arm 7: Self-titrated placebo - Self-titrated Sativex - Fixed dose placebo - Fixed dose Sativex arm 8: Fixed dose Sativex - Fixed dose placebo - Self-titrated Sativex - Self-titrated placebo
Interventions: intervention 1: Sativex intervention 2: Placebo
Intervention descriptions: intervention 1: All participants received the same interventions (Fixed or Self-Titrated Sativex), just in different sequences. intervention 2: All participants received the same interventions (Fixed or Self-Titrated Placebo), just in different sequences.

Protocol documents: