Fixed or Self-Titrated Dosages of Sativex on Cannabis Users

Center for Addiction and Mental Health (CAMH)

Status: Completed

Conditions: Cannabis Dependence

Treatments: Drug: Placebo; Drug: Sativex

Study type: Interventional

Funder types: Other

Identifiers

NCT01748799

103/2011

243152 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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16 participants in 8 patient groups

Sequence 1

Other group

Description:

Self-titrated placebo - Self-titrated Sativex - Fixed dose Sativex - Fixed dose placebo

Treatment:

Drug: Sativex

Drug: Placebo

Sequence 2

Other group

Description:

Fixed dose placebo - Fixed dose Sativex - Self-titrated Sativex - Self-titrated placebo

Treatment:

Drug: Sativex

Drug: Placebo

Sequence 3

Other group

Description:

Fixed dose placebo - Fixed dose Sativex - Self-titrated placebo - Self-titrated Sativex

Treatment:

Drug: Sativex

Drug: Placebo

Sequence 4

Other group

Description:

Fixed dose Sativex - Fixed dose placebo - Self-titrated placebo - Self-titrated Sativex

Treatment:

Drug: Sativex

Drug: Placebo

Sequence 5

Other group

Description:

Self-titrated Sativex - Self-titrated placebo - Fixed dose Sativex - Fixed dose placebo

Treatment:

Drug: Sativex

Drug: Placebo

Sequence 6

Other group

Description:

Self-titrated Sativex - Self-titrated placebo - Fixed dose placebo - Fixed dose Sativex

Treatment:

Drug: Sativex

Drug: Placebo

Sequence 7

Other group

Description:

Self-titrated placebo - Self-titrated Sativex - Fixed dose placebo - Fixed dose Sativex

Treatment:

Drug: Sativex

Drug: Placebo

Sequence 8

Other group

Description:

Fixed dose Sativex - Fixed dose placebo - Self-titrated Sativex - Self-titrated placebo

Treatment:

Drug: Sativex

Drug: Placebo