A double-blind, randomised, placebo controlled trial of SATIVEX® for the management of cannabis withdrawal

Tags: cannabis
Date Commenced:
03/2010
Expected Date of Completion:
03/2013
Project Supporters:
NHMRC
Drug Type:
Project Members
Lecturer
Ph +61 2 9385 0448
Senior Lecturer
Ph 02 9385 0260
Project Collaborators: External
A/Pofessor Nicholas Lintzeris (Director, Drug & Alcohol Services, South East Sydney Local Health Network, & Faculty of Medicine, University of Sydney)
Professor Iain McGregor (Professor, School of Psychology, University of Sydney)
A/Professor Adrian Dunlop (Area Director, Senior Staff Specialist, Drug and Alcohol Clinical Services, Hunter New England Local Health Network, Belmont Hospital)
Dr Mark Montebello (Conjoint Lecturer, School of Psychiatry, University of New South Wales & Senior Staff Specialist in Psychiatry at The Langton Centre)
Dr Craig Sadler (Staff Specialist Addiction Medicine, Director ADU, Calvary Mater Hospital, Director Withdrawal Services, Drug and Alcohol Clinical Services HNEAH, Conjoint Senior Lecturer University of Newcastle)
Project Main Description

Treatment admissions for cannabis use disorders have risen considerably over the last few years, globally and within Australia. There is currently no effective pharmacotherapy for cannabis dependence, and very low abstinence rates reported from psychotherapy alone. A defined cannabis withdrawal syndrome has been identified, and while it is not life threatening, the discomfort it causes is reported to contribute to the high incidence of relapse amongst the cannabis using population. As such cannabis withdrawal may be an important intervention target for dependence on the drug. This study represents the world’s first safety and efficacy trial of a novel agonist medication (Sativex®) for alleviating the symptoms of cannabis withdrawal.

Aims
  1. To assess the effectiveness of Sativex® compared to a placebo control for alleviating the number, severity and duration of cannabis withdrawal symptoms, as well as the overall withdrawal score measured using the Cannabis Withdrawal Scale.
  2. To assess the effect of Sativex® on detoxification completion rates and length of stay in treatment compared with placebo.
  3. To compare reports of adverse events during detoxification treatment between the two groups.
Design and Method

This study is a phase II, multi-site, double-blind, randomised, placebo-controlled inpatient trial. The trial will involve 50 treatment-seeking, cannabis dependent adults.

Progress/Update

Recruitment of 51 DSM-IV dependent cannabis smokers who were seeking treatment for their cannabis use was completed in October 2012 and data collection completed the following month. The data are currently being cleaned and analysed ready for publication in 2013.

Output

Oral presentation to the Cannabis Withdrawal workshop at the November 2012 APSAD meeting in Melbourne.

Benefits

The project may pave the way for the development of the first medication of its type used to alleviate cannabis withdrawal symptoms.

Project Research Area
Project Supporters
NHMRC
Project Status
Current
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