An RCT of cannabinoid replacement therapy (Sativex®) for the management of treatment-resistant cannabis dependent patients

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Date Commenced:
Expected Date of Completion:
Project Supporters:

NHMRC Project Grant

Drug Type:
Project Members: 
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Professor Jan Copeland
Honorary Visiting Professor
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Dr Marian Shanahan
Conjoint Senior Lecturer
Project Main Description: 

This project will conduct the first-ever outpatient RCT to test the efficacy, safety and cost-effectiveness of the pharmaceutical cannabinoid nabiximols (Sativex®) for treating cannabis dependence. This study builds upon recent work by this team demonstrating the safety and efficacy of Sativex in treating inpatient cannabis withdrawal. However chronic addictive disorders are usually associated with high relapse rates following withdrawal, and longer term treatment models that integrate medication and counselling approaches are required.

Project Collaborators: External: 

This research is being led by Associate Professor Nicholas Lintzeris
University of Sydney

Dr David Allsop
University of Sydney

Professor Iain McGregor
University of Sydney

Associate Professor Adrian Dunlop
Hunter New England Local Health District

Associate Professor Raimondo Bruno
University of Tasmania


To examine the efficacy, safety and cost-effectiveness of Sativex for treating cannabis dependent patients in the community who have not previously responded to conventional treatment approaches.

Design and Method: 

This study is a random controlled trial of a double-blind placebo controlled parallel design conducted in multiple sites in Sydney and Newcastle.


Recruitment underway.


The main outcome of this study will be to attempt is to develop an effective agonist replacement therapy for treating severe cannabis dependent persons who have not responded to standard interventions. Current best practice in cannabis treatment involves psychotherapy, which leaves some 80% of people who seek help locked in a spiral of dependence and relapse.

Drug Type: 
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