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BMC Psychiatry
Published in: BMC Psychiatry 1/2024

Open Access 01-12-2024 | Study Protocol

A phase III multisite randomised controlled trial to compare the efficacy of cannabidiol to placebo in the treatment of cannabis use disorder: the CBD-CUD study protocol

Authors: Anjali K. Bhardwaj, Llew Mills, Michael Doyle, Arshman Sahid, Mark Montebello, Lauren Monds, Shalini Arunogiri, Paul Haber, Valentina Lorenzetti, Dan I. Lubman, Peter Malouf, Mary E. Harrod, Adrian Dunlop, Tom Freeman, Nicholas Lintzeris

Published in: BMC Psychiatry | Issue 1/2024

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Abstract

Background

Cannabis use disorder (CUD) is increasingly common and contributes to a range of health and social problems. Cannabidiol (CBD) is a non-intoxicating cannabinoid recognised for its anticonvulsant, anxiolytic and antipsychotic effects with no habit-forming qualities. Results from a Phase IIa randomised clinical trial suggest that treatment with CBD for four weeks reduced non-prescribed cannabis use in people with CUD. This study examines the efficacy, safety and quality of life of longer-term CBD treatment for patients with moderate-to-severe CUD.

Methods/Design

A phase III multi-site, randomised, double-blinded, placebo controlled parallel design of a 12-week course of CBD to placebo, with follow-up at 24 weeks after enrolment.
Two hundred and fifty adults with moderate-to-severe CUD (target 20% Aboriginal), with no significant medical, psychiatric or other substance use disorders from seven drug and alcohol clinics across NSW and VIC, Australia will be enrolled.
Participants will be administered a daily dose of either 4 mL (100 mg/mL) of CBD or a placebo dispensed every 3-weeks. All participants will receive four-sessions of Cognitive Behavioural Therapy (CBT) based counselling. Primary endpoints are self-reported cannabis use days and analysis of cannabis metabolites in urine. Secondary endpoints include severity of CUD, withdrawal severity, cravings, quantity of use, motivation to stop and abstinence, medication safety, quality of life, physical/mental health, cognitive functioning, and patient treatment satisfaction. Qualitative research interviews will be conducted with Aboriginal participants to explore their perspectives on treatment.

Discussion

Current psychosocial and behavioural treatments for CUD indicate that over 80% of patients relapse within 1–6 months of treatment. Pharmacological treatments are highly effective with other substance use disorders but there are no approved pharmacological treatments for CUD. CBD is a promising candidate for CUD treatment due to its potential efficacy for this indication and excellent safety profile. The anxiolytic, antipsychotic and neuroprotective effects of CBD may have added benefits by reducing many of the mental health and cognitive impairments reported in people with regular cannabis use.

Trial registration

Australian and New Zealand Clinical Trial Registry: ACTRN12623000526673 (Registered 19 May 2023).
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Metadata
Title
A phase III multisite randomised controlled trial to compare the efficacy of cannabidiol to placebo in the treatment of cannabis use disorder: the CBD-CUD study protocol
Authors
Anjali K. Bhardwaj
Llew Mills
Michael Doyle
Arshman Sahid
Mark Montebello
Lauren Monds
Shalini Arunogiri
Paul Haber
Valentina Lorenzetti
Dan I. Lubman
Peter Malouf
Mary E. Harrod
Adrian Dunlop
Tom Freeman
Nicholas Lintzeris
Publication date
01-12-2024
Publisher
BioMed Central
Published in
BMC Psychiatry / Issue 1/2024
Electronic ISSN: 1471-244X
DOI
https://doi.org/10.1186/s12888-024-05616-3

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