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

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posted on 2023-05-20, 01:43 authored by Bhardwaj, AK, Allsop, DJ, Copeland, J, McGregor, IS, Dunlop, A, Shanahan, M, Raimondo BrunoRaimondo Bruno, Phung, N, Montebello, M, Sadler, C, Gugusheff, J, Jackson, M, Luksza, J, Lintzeris, N, Hall, M, Hazelwood, S, Winmill, A, Chan, T, Dojcinovic, R, Jago, B, McKendrick, L, Rivas, C, Schwanz, R, Yang, A, Zavareh, Z, Barbaro, A, Black, K, Ho, T, Jefferies, M, Jule, JC, Nagubandi, S, Shahidi, M, Lisa Snell, CS, Wijanto, M

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).

History

Publication title

BMC Psychiatry

Volume

18

Article number

140

Number

140

Pagination

1-14

ISSN

1471-244X

Department/School

School of Psychological Sciences

Publisher

BioMed Central Ltd.

Place of publication

United Kingdom

Rights statement

Copyright 2018 The Author(s) Licensed under Creative Commons Attribution 4.0 International (CC BY 4.0) https://creativecommons.org/licenses/by/4.0/

Repository Status

  • Open

Socio-economic Objectives

Expanding knowledge in psychology

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