A phase III multisite randomised controlled trial to compare the efficacy of cannabidiol to placebo in the treatment of cannabis use disorder: the CBD-CUD study protocol
Open accessAbstract
Background: Cannabis use disorder (CUD) is increasingly common and contributes to a range of health and social problems. Cannabidiol (CBD) is a non-intoxicating cannabinoid recognised for its anticonvulsant, anxiolytic and antipsychotic effects with no habit-forming qualities. Results from a Phase IIa randomised clinical trial suggest that treatment with CBD for four weeks reduced non-prescribed cannabis use in people with CUD. This study examines the efficacy, safety and quality of life of longer-term CBD treatment for patients with moderate-to-severe CUD. Methods/Design: A phase III multi-site, randomised, double-blinded, placebo controlled parallel design of a 12-week course of CBD to placebo, with follow-up at 24 weeks after enrolment. Two hundred and fifty adults with moderate-to-severe CUD (target 20% Aboriginal), with no significant medical, psychiatric or other substance use disorders from seven drug and alcohol clinics across NSW and VIC, Australia will be enrolled. Participants will be administered a daily dose of either 4 mL (100 mg/mL) of CBD or a placebo dispensed every 3-weeks. All participants will receive four-sessions of Cognitive Behavioural Therapy (CBT) based counselling. Primary endpoints are self-reported cannabis use days and analysis of cannabis metabolites in urine. Secondary endpoints include severity of CUD, withdrawal severity, cravings, quantity of use, motivation to stop and abstinence, medication safety, quality of life, physical/mental health, cognitive functioning, and patient treatment satisfaction. Qualitative research interviews will be conducted with Aboriginal participants to explore their perspectives on treatment. Discussion: Current psychosocial and behavioural treatments for CUD indicate that over 80% of patients relapse within 1–6 months of treatment. Pharmacological treatments are highly effective with other substance use disorders but there are no approved pharmacological treatments for CUD. CBD is a promising candidate for CUD treatment due to its potential efficacy for this indication and excellent safety profile. The anxiolytic, antipsychotic and neuroprotective effects of CBD may have added benefits by reducing many of the mental health and cognitive impairments reported in people with regular cannabis use. Trial registration: Australian and New Zealand Clinical Trial Registry: ACTRN12623000526673 (Registered 19 May 2023).
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TGT is an effective option compared with conventional substance use treatments for young people in both the short and long term, reducing psychoactive substance use, improving quality of life and maintaining improvements during follow-up.
“The effects of TGT have been compared with other traditional therapies, such as CBT or group therapy, and have shown that TGT is an effective option compared with conventional substance use treatments for young people in both the short and long term, reducing psychoactive substance use, improving quality of life and maintaining improvements during follow-up [1,28,29,30,31,32].”
From Third-Generation Therapies for the Management of Psychoactive Substance Use in Young People: Scoping Review (2024) · cites this paper as [28]
The Introduction (‘Treatment for CUD’; page unavailable) discusses CBT and other cannabis-use-disorder treatments but does not address TGT. Searches for TGT, comparisons with CBT or group therapy in young people, and sustained quality-of-life improvements found no relevant finding. The Methods describe planned outcomes for a cannabidiol-versus-placebo trial, not results for TGT. (LLM, conf=0.77)
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Sequeda, G., Acosta-López, J. E., Diaz-Camargo, E., Torres-Santos, E.-A., López-Ramírez, V., & Rivera-Porras, D. (2024) · Behavioral Sciences · doi:10.3390/bs14121192 · Cited by 7 · see citing works
- Authors
- Bhardwaj, A. K., Mills, L., Doyle, M., Sahid, A., Montebello, M., Monds, L., Arunogiri, S., Haber, P., Lorenzetti, V., Lubman, D. I., Malouf, P., Harrod, M. E., Dunlop, A., Freeman, T., & Lintzeris, N.
- Affiliations
- The University of Sydney (AU)
- Australian Catholic University (AU)
- UNSW Sydney (AU)
- Hunter New England Local Health District (AU)
- University of Bath (GB)
- Corresponding author
- Bhardwaj, Anjali K.
- ORCID
- Venue
- BMC Psychiatry
- Published
- 2024-03-04
- Volume
- 24
- Issue
- 1
- Pages
- 175-175
- ISSN
- 1471-244X (ISSN-L)
- PMC
- PMC10910760
- OpenAlex
- W4392371995
- Cited by
- 10
- References
- 74
- Citations by year
- 2025: 6 · 2024: 4
- FWCI
- 2.84
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- BMC Psychiatry (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
- Funders
- Jazz Pharmaceuticals
- Medical Research Council
- National Health and Medical Research Council (2014980)
- Topics
- Health Sciences › Medicine › Pharmacology › Cannabis and Cannabinoid Research
- Health Sciences › Medicine › Epidemiology › Substance Abuse Treatment and Outcomes
- Health Sciences › Medicine › Physiology › Smoking Behavior and Cessation
- Keywords
- cannabis use disorder, cannabidiol, pharmacotherapy, cognitive behavioral therapy, cannabis metabolites, withdrawal, craving, abstinence, Aboriginal Australians, quality of life, treatment safety, relapse
- MeSH terms
- Adult, Australia, Cannabidiol, Cannabis, Marijuana Abuse, Hallucinogens, Humans, Quality of Life, Antipsychotic Agents, Anti-Anxiety Agents, Randomized Controlled Trials as Topic, Clinical Trials, Phase III as Topic, Substance-Related Disorders
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