Clinical trial NCT01748799: Fixed or Self-Titrated Dosages of Sativex on Cannabis Users
Official title: Effects of Fixed or Self-Titrated Dosages of Sativex on Cannabis Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cannabis Dependence
Keywords: Cannabis dependence
Sativex
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2012-12-13
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility
timeFrame: 12 months
Secondary outcomes:
measure: Tolerability of Sativex in Persons That Are Cannabis Dependent
timeFrame: 8 weeks
measure: Cannabis Withdrawal
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Centre for Addiction and Mental Health
name: Bernard Le Foll
role: PRINCIPAL_INVESTIGATOR
References: