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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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Bhardwaj, AK, Allsop, DJ, Copeland, J, McGregor, IS, Dunlop, A, Shanahan, M, Bruno, R ORCID: 0000-0001-6673-833X, 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 and Wijanto, M 2018 , 'Randomised Controlled Trial (RCT) of cannabinoid replacement therapy (Nabiximols) for the management of treatment-resistant cannabis dependent patients: A study protocol' , BMC Psychiatry, vol. 18, no. 1 , pp. 1-14 , doi: 10.1186/s12888-018-1682-2.

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Abstract

Background: The cannabis extract nabiximols (Sativex®) effectively supresses withdrawal symptoms and cravings intreatment resistant cannabis dependent individuals, who have high relapse rates following conventional withdrawaltreatments. This study examines the efficacy, safety and cost-effectiveness of longer-term nabiximols treatment for outpatientcannabis 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 othersubstance 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, dispensedweekly. 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 QualityAdjusted Life Years). Secondary outcomes include, improvement in physical and mental health parameters, substance useother than cannabis, cognitive functioning and patient satisfaction measures.Discussion: This is the first outpatient community-based randomised controlled study of nabiximols as an agonistreplacement medication for treating cannabis dependence, targeting individuals who have not previously responded toconventional treatment approaches. The study and treatment design is modelled upon an earlier study with this populationand more generally on other agonist replacement treatments (e.g. nicotine, opioids).

Item Type: Article
Authors/Creators:Bhardwaj, AK and Allsop, DJ and Copeland, J and McGregor, IS and Dunlop, A and Shanahan, M and Bruno, R and Phung, N and Montebello, M and Sadler, C and Gugusheff, J and Jackson, M and Luksza, J and Lintzeris, N and Hall, M and Hazelwood, S and Winmill, A and Chan, T and Dojcinovic, R and Jago, B and McKendrick, L and Rivas, C and Schwanz, R and Yang, A and Zavareh, Z and Barbaro, A and Black, K and Ho, T and Jefferies, M and Jule, JC and Nagubandi, S and Shahidi, M and Lisa Snell, CS and Wijanto, M
Journal or Publication Title: BMC Psychiatry
Publisher: BioMed Central Ltd.
ISSN: 1471-244X
DOI / ID Number: 10.1186/s12888-018-1682-2
Copyright Information:

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

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