Cannabidiol (CBD) for Alcohol Use Disorder (AUD) Management A Multi_x0002_site, Double blind, Placebo controlled, Randomised Controlled Trial for reducing heavy drinking in adults.

Cannabidiol (CBD) for Alcohol Use Disorder (AUD) Management A Multi_x0002_site, Double blind, Placebo controlled, Randomised Controlled Trial. A study in adults with AUD, to reduce heavy drinking.

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12626001011370

Acronym

CBD-AUD

Enrollment

280

Registered

2026-08-17

Start date

2026-10-26

Completion date

2029-01-29

Last updated

2026-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This is a randomised, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy of cannabidiol (CBD) compared with placebo in reducing alcohol consumption among adults with alcohol use disorder (AUD). Participants who have an Alcohol Used Disorder will be given bottles of CBD (or placebo) to take the recommended dose each day (a few drops, applied orally) for 12 weeks. Participants will attend for regular checks and drug dispensing during the treatment period. At Week 12, participants will have various checks to confirm whether drinking has reduced, again 12 weeks later an appointment will be held to check how participants have managed in the absence of the study drug .

Interventions

Cannabidiol (CBD) dosed daily for 12 weeks, starting at 400mg, titrating up to 800mg if tolerated. At Week 3, if tolerated, dose will be titrated to 600mg daily. At West 6, this will be assessed again and participant will be titrated up to 800mg daily. If safety concerns arise, dose will be reduced. CBD administered by participants, throgh oral drops. Drug bottle to be returned and weighed to crosscheck against drug diary for purposes of drug accountability.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

Moderate to severe Alcohol Use Disorder (DSM-5) • Desire to reduce or stop drinking • Consumed >30 standard drinks/week or 3 heavy drinking days/week in the previous month o HDD: >5 standard drinks/day for men; >4 for women • Age 18–65 years • Adequate cognition to give valid consent and complete interviews • Stable housing • Willingness to give informed consent • History of >10 years of problem alcohol use, inpatient or rehabilitation treatment, and unsuccessful response to psychosocial or pharmacotherapy

Exclusion criteria

Active psychological disorder with psychosis or suicide risk • Pregnancy or lactation (confirmed by urine ß-hCG at screening) • Concurrent psychotropic medications (except antidepressants if stable for >2 months) • Substance dependence other than nicotine • Clinically unstable systemic medical disorder • Epilepsy and/or concurrent anti-epileptic medications • Moderate to severe liver disease (transaminase elevations >3× upper limit of normal; bilirubin >2× upper limit) • Concurrent medications with potential metabolic interactions with CBD via CYP3A4, CYP2C9, CYP2C19 • Alcohol pharmacotherapy within the past month • Previous sensitivity to medicinal cannabis products • Cannabis use (including medicinal cannabis) within the past month

Outcome results