Evidence map›Paper›PMID 38433233›Full record

ArticleBMC psychiatry2024

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.

Anjali K Bhardwaj, Llew Mills, Michael Doyle, Arshman Sahid, Mark Montebello, Lauren Monds, Shalini Arunogiri, Paul Haber, Valentina Lorenzetti, Dan I Lubman and 5 more

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC psychiatry, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 2 pooled it
4.5field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 2 syntheses or guidelines pooled it, 10 citations in OpenAlex.

  1. Guideline
  2. Pharmacotherapies for cannabis use disorder.The Cochrane database of systematic reviews · 2025
    Pooled it
  3. Review
  4. Article
  5. Prevalence of cannabidiol use and correlates in U.S. adults.Drug and alcohol dependence reports · 2024
    Article
  6. The Pharmacology of Cannabinoids in Chronic Pain.Medical cannabis and cannabinoids
    Review
  7. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 7 institutions in 2 countries.

Anjali K BhardwajFaculty of Medicine, University of Sydney, Camperdown, NSW, Australia. Anjali.bhardwaj@sydney.edu.au.
Llew MillsFaculty of Medicine, University of Sydney, Camperdown, NSW, Australia.
Michael DoyleFaculty of Medicine, University of Sydney, Camperdown, NSW, Australia.
Arshman SahidFaculty of Medicine, University of Sydney, Camperdown, NSW, Australia.
Mark MontebelloFaculty of Medicine, University of Sydney, Camperdown, NSW, Australia.
Lauren MondsFaculty of Medicine, University of Sydney, Camperdown, NSW, Australia.
Shalini ArunogiriCentre for Addiction and Mental Health, Turning Point, Victoria, Australia.
Paul HaberFaculty of Medicine, University of Sydney, Camperdown, NSW, Australia.
Valentina LorenzettiFaculty of Health Science, Australian Catholic University, Victoria, Australia.
Dan I LubmanCentre for Addiction and Mental Health, Turning Point, Victoria, Australia.
Peter MaloufMedicine and Health, University of New South Wales, Sydney, NSW, Australia.
Mary E HarrodNSW Users and AIDS Association, Sydney, NSW, Australia.
Adrian DunlopDrug and Alcohol Clinical Services, Hunter New England Local Health District, Newcastle, NSW, Australia.
Tom FreemanAddiction and Mental Health Group, University of Bath, Bath, UK.
Nicholas LintzerisFaculty of Medicine, University of Sydney, Camperdown, NSW, Australia.
University of Sydney · AUSydney Local Health District · AUAustralian Catholic University · AUHunter New England Local Health District · AUNorthern Sydney Local Health District · AUUniversity of Bath · GBUNSW Sydney · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCannabis 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/

designA 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 registrationAustralian and New Zealand Clinical Trial Registry: ACTRN12623000526673 (Registered 19 May 2023).

Indexed as

Anti-Anxiety AgentsAntipsychotic AgentsCannabidiolCannabisHallucinogensMarijuana AbuseSubstance-Related DisordersAdultAustraliaClinical Trials, Phase III as TopicHumansQuality of LifeRandomized Controlled Trials as TopicAnti-Anxiety AgentsAntipsychotic AgentsCannabidiolHallucinogensCannabidiolCannabisCannabis use disorderCannabis withdrawalMarijuanaStudy protocol

Identifiers

PMID38433233
PMCPMC10910760
OpenAlexW4392371995

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.