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BMC Psychiatry
Published in: BMC Psychiatry 1/2018

Open Access 01-12-2018 | Study protocol

Randomised Controlled Trial (RCT) of cannabinoid replacement therapy (Nabiximols) for the management of treatment-resistant cannabis dependent patients: a study protocol

Authors: Anjali K. Bhardwaj, David J. Allsop, Jan Copeland, Iain S. McGregor, Adrian Dunlop, Marian Shanahan, Raimondo Bruno, Nghi Phung, Mark Montebello, Craig Sadler, Jessica Gugusheff, Melissa Jackson, Jennifer Luksza, Nicholas Lintzeris, Agonist Replacement for Cannabis Dependence (ARCD) study group

Published in: BMC Psychiatry | Issue 1/2018

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Abstract

Background

The cannabis extract nabiximols (Sativex®) effectively supresses withdrawal symptoms and cravings in treatment resistant cannabis dependent individuals, who have high relapse rates following conventional withdrawal treatments. This study examines the efficacy, safety and cost-effectiveness of longer-term nabiximols treatment for outpatient cannabis dependent patients who have not responded to previous conventional treatment approaches.

Methods/Design

A phase III multi-site outpatient, randomised, double-blinded, placebo controlled parallel design, comparing a 12-week course of nabiximols to placebo, with follow up at 24 weeks after enrolment.
Four specialist drug and alcohol outpatient clinics in New South Wales, Australia.
One hundred forty-two treatment seeking cannabis dependent adults, with no significant medical, psychiatric or other substance use disorders.
Nabiximols is an oromucosal spray prescribed on a flexible dose regimen to a maximum daily dose of 32 sprays; 8 sprays (total 21.6 mg tetrahydrocannabinol (THC) and 20 mg cannabidiol (CBD)) four times a day, or matching placebo, dispensed weekly. All participants will receive six-sessions of individual cognitive behavioural therapy (CBT) and weekly clinical reviews.
Primary endpoints are use of non-prescribed cannabis (self-reported cannabis use days, urine toxicology), safety measures (adverse events and abuse liability), and cost effectiveness (incremental cost effectiveness in achieving additional Quality Adjusted Life Years). Secondary outcomes include, improvement in physical and mental health parameters, substance use other than cannabis, cognitive functioning and patient satisfaction measures.

Discussion

This is the first outpatient community-based randomised controlled study of nabiximols as an agonist replacement medication for treating cannabis dependence, targeting individuals who have not previously responded to conventional treatment approaches. The study and treatment design is modelled upon an earlier study with this population and more generally on other agonist replacement treatments (e.g. nicotine, opioids).

Trial registration

Australian and New Zealand Clinical Trial Registry: ACTRN12616000103​460 (Registered 1st February 2016).
Appendix
Available only for authorised users
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Metadata
Title
Randomised Controlled Trial (RCT) of cannabinoid replacement therapy (Nabiximols) for the management of treatment-resistant cannabis dependent patients: a study protocol
Authors
Anjali K. Bhardwaj
David J. Allsop
Jan Copeland
Iain S. McGregor
Adrian Dunlop
Marian Shanahan
Raimondo Bruno
Nghi Phung
Mark Montebello
Craig Sadler
Jessica Gugusheff
Melissa Jackson
Jennifer Luksza
Nicholas Lintzeris
Agonist Replacement for Cannabis Dependence (ARCD) study group
Publication date
01-12-2018
Publisher
BioMed Central
Published in
BMC Psychiatry / Issue 1/2018
Electronic ISSN: 1471-244X
DOI
https://doi.org/10.1186/s12888-018-1682-2

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