Fixed or Self-Titrated Dosages of Sativex on Cannabis Users

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cannabis Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Sequence 1

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

Group Type OTHER

Sativex

Intervention Type DRUG

All participants received the same interventions (Fixed or Self-Titrated Sativex), just in different sequences.

Placebo

Intervention Type DRUG

All participants received the same interventions (Fixed or Self-Titrated Placebo), just in different sequences.

Sequence 2

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

Group Type OTHER

Sativex

Intervention Type DRUG

All participants received the same interventions (Fixed or Self-Titrated Sativex), just in different sequences.

Placebo

Intervention Type DRUG

All participants received the same interventions (Fixed or Self-Titrated Placebo), just in different sequences.

Sequence 3

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

Group Type OTHER

Sativex

Intervention Type DRUG

All participants received the same interventions (Fixed or Self-Titrated Sativex), just in different sequences.

Placebo

Intervention Type DRUG

All participants received the same interventions (Fixed or Self-Titrated Placebo), just in different sequences.

Sequence 4

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

Group Type OTHER

Sativex

Intervention Type DRUG

All participants received the same interventions (Fixed or Self-Titrated Sativex), just in different sequences.

Placebo

Intervention Type DRUG

All participants received the same interventions (Fixed or Self-Titrated Placebo), just in different sequences.

Sequence 5

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

Group Type OTHER

Sativex

Intervention Type DRUG

All participants received the same interventions (Fixed or Self-Titrated Sativex), just in different sequences.

Placebo

Intervention Type DRUG

All participants received the same interventions (Fixed or Self-Titrated Placebo), just in different sequences.

Sequence 6

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

Group Type OTHER

Sativex

Intervention Type DRUG

All participants received the same interventions (Fixed or Self-Titrated Sativex), just in different sequences.

Placebo

Intervention Type DRUG

All participants received the same interventions (Fixed or Self-Titrated Placebo), just in different sequences.

Sequence 7

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

Group Type OTHER

Sativex

Intervention Type DRUG

All participants received the same interventions (Fixed or Self-Titrated Sativex), just in different sequences.

Placebo

Intervention Type DRUG

All participants received the same interventions (Fixed or Self-Titrated Placebo), just in different sequences.

Sequence 8

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

Group Type OTHER

Sativex

Intervention Type DRUG

All participants received the same interventions (Fixed or Self-Titrated Sativex), just in different sequences.

Placebo

Intervention Type DRUG

All participants received the same interventions (Fixed or Self-Titrated Placebo), just in different sequences.

Interventions

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Sativex

All participants received the same interventions (Fixed or Self-Titrated Sativex), just in different sequences.

Intervention Type DRUG

Placebo

All participants received the same interventions (Fixed or Self-Titrated Placebo), just in different sequences.

Intervention Type DRUG

Other Intervention Names

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Delta-9-tetrahydrocannabinol and cannabidiol Ethanol, propylene glycol and peppermint oil with colors

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No