Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001011370
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
14/07/2026
Date registered
Help: Date registered
17/08/2026
Date last updated
Help: Date last updated
17/08/2026
Date data sharing statement initially provided
Help: Data sharing statement date
17/08/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Cannabidiol (CBD) for Alcohol Use Disorder (AUD) Management A Multisite, Double blind, Placebo controlled, Randomised Controlled Trial for reducing heavy drinking in adults.
Scientific title
Cannabidiol (CBD) for Alcohol Use Disorder (AUD) Management A Multisite, Double blind, Placebo controlled, Randomised Controlled Trial. A study in adults with AUD, to reduce heavy drinking.
Additional trial identifiers [1] 318043 0
Nil
Universal Trial Number (UTN)
Trial acronym
CBD-AUD
Related trial records

Health condition
Health condition(s) studied:
Alcohol Use Disorder 342848 0
Condition category
Condition code
Mental Health 338960 338960 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
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.
Intervention code [1] 334745 0
Lifestyle
Description of the comparator or control
A bottle (with a dropper) of liquid (made from sesame/coconut oil) that is matched in appearance and taste to Cannabidiol CBD.
Control group
Placebo

Outcomes
Primary outcome [1] 346202 0
Number of heavy drinking days (HDDs; >5 standard drinks for men, >4 for women) per week over the 12-week treatment period, measured at end of treatment (Week 12) compared to baseline.
Timepoint [1] 346202 0
PEth test performed once at baseline and end of treatment (12 weeks). Over 12-week treatment period, and 12-week follow-up period (total of 24 weeks), the Timeline Follow-back will be conducted at the following timepoints: Baseline, Weeks 1,3,6,12 & 24.
Secondary outcome [1] 464970 0
Anxiety
Timepoint [1] 464970 0
Baseline, Weeks 6 (mid treatment), 12 (end of treatment), 24 (12 weeks from end of treatment)
Secondary outcome [2] 465615 0
Depression
Timepoint [2] 465615 0
Baseline, Weeks 6 (mid treatment), 12 (end of treatment), 24 (12 weeks from end of treatment)
Secondary outcome [3] 465616 0
PTSD
Timepoint [3] 465616 0
Baseline, Weeks 6 (mid treatment), 12 (end of treatment), 24 (12 weeks from end of treatment)
Secondary outcome [4] 465617 0
Social phobia
Timepoint [4] 465617 0
Baseline, Weeks 6 (mid treatment), 12 (end of treatment), 24 (12 weeks from end of treatment)
Secondary outcome [5] 465618 0
Sleep disturbance
Timepoint [5] 465618 0
Baseline, Weeks 6 (mid treatment), 12 (end of treatment), 24 (12 weeks from end of treatment)
Secondary outcome [6] 465619 0
quality of life
Timepoint [6] 465619 0
Baseline, Weeks 6 (mid treatment), 12 (end of treatment), 24 (12 weeks from end of treatment)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Healthy volunteers
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/10/2026
Actual
Date of last participant enrolment
Anticipated
29/01/2029
Actual
Date of last data collection
Anticipated
31/07/2029
Actual
Sample size
Target
280
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 29833 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 29834 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [3] 29835 0
The Langton Centre - Surry Hills
Recruitment postcode(s) [1] 46185 0
2050 - Camperdown
Recruitment postcode(s) [2] 46186 0
2065 - St Leonards
Recruitment postcode(s) [3] 46187 0
2010 - Surry Hills

Funding & Sponsors
Funding source category [1] 322436 0
Government body
Name [1] 322436 0
National Health and Medical Research Council (NHMRC) CTS Grant
Country [1] 322436 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 325362 0
None
Name [1] 325362 0
Address [1] 325362 0
Country [1] 325362 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320929 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 320929 0
Ethics committee country [1] 320929 0
Australia
Date submitted for ethics approval [1] 320929 0
11/03/2026
Approval date [1] 320929 0
28/04/2026
Ethics approval number [1] 320929 0
X26-0055

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 152110 0
Prof Kirste Morley
Address 152110 0
University of Sydney King George V Building, Missenden Road Campedown NSW 2050
Country 152110 0
Australia
Phone 152110 0
+61400365131
Fax 152110 0
Email 152110 0
[email protected]
Contact person for public queries
Name 152111 0
Nathan Bradshaw
Address 152111 0
University of Sydney, King George V Building, Missenden Road Campedown NSW 2050
Country 152111 0
Australia
Phone 152111 0
+61408807332
Fax 152111 0
Email 152111 0
[email protected]
Contact person for scientific queries
Name 152112 0
Nathan Bradshaw
Address 152112 0
University of Sydney, King George V Building, Missenden Road Campedown NSW 2050
Country 152112 0
Australia
Phone 152112 0
+61408807332
Fax 152112 0
Email 152112 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.