Randomised Controlled Trial (RCT) of cannabinoid replacement therapy (Nabiximols) for the management of treatment-resistant cannabis dependent patients: a study protocol
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
References
Nabiximols as an agonist replacement therapy during cannabis withdrawal: a randomized clinical trial
Citations
Validation of the Australian Treatment Outcomes Profile for use in clients with cannabis dependence.
Clinical Significance and Outcomes in Trial of Nabiximols for Treatment of Cannabis Dependence-Reply
Methods Mentioned
Software Mentioned
Related Concepts
Related Feeds
Cannabis & Cognition
The effect of cannabis on cognitive functioning is being explored for short and long-term effects. Recent studies have shown conflicting results, with some showing no significant effects and others showing neuropsychological impairment. Discover the latest research on cannabis and cognition here.