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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.
BMC Psychiatry. 2018 05 18; 18(1):140.BP

Abstract

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).

TRIAL REGISTRATION

Australian and New Zealand Clinical Trial Registry: ACTRN12616000103460 (Registered 1st February 2016).

Authors+Show Affiliations

Discipline of Addiction Medicine, Central Clinical School, University of Sydney, Sydney, NSW, Australia. anjali.bhardwaj@sydney.edu.au. The Langton Centre, Drug and Alcohol Services, South Eastern Sydney Local Health District, Sydney, NSW, Australia. anjali.bhardwaj@sydney.edu.au. School of Psychology, University of Sydney, Sydney, NSW, Australia. anjali.bhardwaj@sydney.edu.au.School of Psychology, University of Sydney, Sydney, NSW, Australia.National Drug and Alcohol Research Centre, University of New South Wales, Sydney, NSW, Australia.School of Psychology, University of Sydney, Sydney, NSW, Australia.Drug and Alcohol Clinical Services, Hunter New England Local Health District, Newcastle, NSW, Australia.National Drug and Alcohol Research Centre, University of New South Wales, Sydney, NSW, Australia.National Drug and Alcohol Research Centre, University of New South Wales, Sydney, NSW, Australia. School of Medicine, University of Tasmania, Hobart, TAS, Australia.Centre for Addiction Medicine, Cumberland Hospital, Western Sydney Local Health District, Sydney, NSW, Australia.The Langton Centre, Drug and Alcohol Services, South Eastern Sydney Local Health District, Sydney, NSW, Australia.Drug and Alcohol Clinical Services, Hunter New England Local Health District, Newcastle, NSW, Australia.Discipline of Addiction Medicine, Central Clinical School, University of Sydney, Sydney, NSW, Australia. The Langton Centre, Drug and Alcohol Services, South Eastern Sydney Local Health District, Sydney, NSW, Australia.Drug and Alcohol Clinical Services, Hunter New England Local Health District, Newcastle, NSW, Australia.Centre for Addiction Medicine, Cumberland Hospital, Western Sydney Local Health District, Sydney, NSW, Australia.Discipline of Addiction Medicine, Central Clinical School, University of Sydney, Sydney, NSW, Australia. The Langton Centre, Drug and Alcohol Services, South Eastern Sydney Local Health District, Sydney, NSW, Australia.No affiliation info available

Pub Type(s)

Clinical Trial Protocol
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

29776349

Citation

Bhardwaj, Anjali K., et al. "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, 2018, p. 140.
Bhardwaj AK, Allsop DJ, Copeland J, et al. Randomised Controlled Trial (RCT) of cannabinoid replacement therapy (Nabiximols) for the management of treatment-resistant cannabis dependent patients: a study protocol. BMC Psychiatry. 2018;18(1):140.
Bhardwaj, A. K., Allsop, D. J., Copeland, J., McGregor, I. S., Dunlop, A., Shanahan, M., Bruno, R., Phung, N., Montebello, M., Sadler, C., Gugusheff, J., Jackson, M., Luksza, J., & Lintzeris, N. (2018). Randomised Controlled Trial (RCT) of cannabinoid replacement therapy (Nabiximols) for the management of treatment-resistant cannabis dependent patients: a study protocol. BMC Psychiatry, 18(1), 140. https://doi.org/10.1186/s12888-018-1682-2
Bhardwaj AK, et al. Randomised Controlled Trial (RCT) of Cannabinoid Replacement Therapy (Nabiximols) for the Management of Treatment-resistant Cannabis Dependent Patients: a Study Protocol. BMC Psychiatry. 2018 05 18;18(1):140. PubMed PMID: 29776349.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Randomised Controlled Trial (RCT) of cannabinoid replacement therapy (Nabiximols) for the management of treatment-resistant cannabis dependent patients: a study protocol. AU - Bhardwaj,Anjali K, AU - Allsop,David J, AU - Copeland,Jan, AU - McGregor,Iain S, AU - Dunlop,Adrian, AU - Shanahan,Marian, AU - Bruno,Raimondo, AU - Phung,Nghi, AU - Montebello,Mark, AU - Sadler,Craig, AU - Gugusheff,Jessica, AU - Jackson,Melissa, AU - Luksza,Jennifer, AU - Lintzeris,Nicholas, AU - ,, Y1 - 2018/05/18/ PY - 2017/08/31/received PY - 2018/03/28/accepted PY - 2018/5/20/entrez PY - 2018/5/20/pubmed PY - 2019/3/6/medline KW - Agonist replacement KW - Cannabis KW - Cannabis withdrawal KW - Marijuana KW - Nabiximols KW - Study protocol SP - 140 EP - 140 JF - BMC psychiatry JO - BMC Psychiatry VL - 18 IS - 1 N2 - 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). TRIAL REGISTRATION: Australian and New Zealand Clinical Trial Registry: ACTRN12616000103460 (Registered 1st February 2016). SN - 1471-244X UR - https://www.unboundmedicine.com/medline/citation/29776349/Randomised_Controlled_Trial__RCT__of_cannabinoid_replacement_therapy__Nabiximols__for_the_management_of_treatment_resistant_cannabis_dependent_patients:_a_study_protocol_ L2 - https://bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-018-1682-2 DB - PRIME DP - Unbound Medicine ER -