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

BMC Psychiatry
Anjali K BhardwajAgonist Replacement for Cannabis Dependence (ARCD) study group

Abstract

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. 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...Continue Reading

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Citations

Jan 29, 2019·The Cochrane Database of Systematic Reviews·Suzanne NielsenBernard Le Foll
May 29, 2019·The American Journal of Drug and Alcohol Abuse·Mallory J E LoflinMarcel O Bonn-Miller
Jul 16, 2019·JAMA Internal Medicine·Nicholas LintzerisUNKNOWN Agonist Replacement for Cannabis Dependence (ARCD) study group
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Jan 7, 2020·JAMA Internal Medicine·Nicholas LintzerisRaimondo Bruno
Aug 15, 2019·Neurotoxicology·Stefania BonaccorsoFabrizio Schifano
Jun 8, 2021·Frontiers in Pharmacology·Francisco NavarreteJorge Manzanares

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Methods Mentioned

BETA
pharmacotherapies
cognitive behavioural therapy
contraception
urine collection

Software Mentioned

Penscreen
ORBIT

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