Fixed or Self-Titrated Dosages of Sativex on Cannabis Users

Not Applicable

Completed

Conditions: Cannabis Dependence

Interventions: Drug: Sativex
Drug: Placebo

Registration Number: NCT01748799

Lead Sponsor: Centre for Addiction and Mental Health

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 16

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 2	Placebo	Fixed dose placebo - Fixed dose Sativex - Self-titrated Sativex - Self-titrated placebo
Sequence 1	Placebo	Self-titrated placebo - Self-titrated Sativex - Fixed dose Sativex - Fixed dose placebo
Sequence 4	Placebo	Fixed dose Sativex - Fixed dose placebo - Self-titrated placebo - Self-titrated Sativex
Sequence 6	Placebo	Self-titrated Sativex - Self-titrated placebo - Fixed dose placebo - Fixed dose Sativex
Sequence 8	Placebo	Fixed dose Sativex - Fixed dose placebo - Self-titrated Sativex - Self-titrated placebo
Sequence 5	Placebo	Self-titrated Sativex - Self-titrated placebo - Fixed dose Sativex - Fixed dose placebo
Sequence 3	Placebo	Fixed dose placebo - Fixed dose Sativex - Self-titrated placebo - Self-titrated Sativex
Sequence 7	Placebo	Self-titrated placebo - Self-titrated Sativex - Fixed dose placebo - Fixed dose Sativex
Sequence 1	Sativex	Self-titrated placebo - Self-titrated Sativex - Fixed dose Sativex - Fixed dose placebo
Sequence 2	Sativex	Fixed dose placebo - Fixed dose Sativex - Self-titrated Sativex - Self-titrated placebo
Sequence 3	Sativex	Fixed dose placebo - Fixed dose Sativex - Self-titrated placebo - Self-titrated Sativex
Sequence 4	Sativex	Fixed dose Sativex - Fixed dose placebo - Self-titrated placebo - Self-titrated Sativex
Sequence 5	Sativex	Self-titrated Sativex - Self-titrated placebo - Fixed dose Sativex - Fixed dose placebo
Sequence 6	Sativex	Self-titrated Sativex - Self-titrated placebo - Fixed dose placebo - Fixed dose Sativex
Sequence 7	Sativex	Self-titrated placebo - Self-titrated Sativex - Fixed dose placebo - Fixed dose Sativex
Sequence 8	Sativex	Fixed dose Sativex - Fixed dose placebo - Self-titrated Sativex - Self-titrated placebo

Primary Outcome Measures

Name	Time	Method
Feasibility	12 months	Feasibility will be assessed by analysing how many participants can be recruited/complete the whole (randomly assigned) experimental sequence with a period of one year.

Secondary Outcome Measures

Name	Time	Method
Tolerability of Sativex in Persons That Are Cannabis Dependent	8 weeks	To assess what number of participants might withdrew due non-tolerability of Sativex
Cannabis Withdrawal	8 weeks	Withdrawal symptoms were assessed using the Cannabis Withdrawal Scale (CWS) (Minimum-Maximum Scores 0-190, high scores represent more withdrawal) and Cannabis Withdrawal Checklist (CWC) (Minimum-Maximum Scores 0-48, high scores represent more withdrawal) by establishing comparisons between Sativex/Placebo and Smoke as usual conditions (4 interventions: Fixed Sativex, Fixed Placebo, Self-titrated Sativex, Self-titrated Placebo and 4 corresponding Smoke as usual conditions).