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

INTERVENTION: 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. CONDITION: Alcohol Use Disorder; ; Alcohol Use Disorder Mental Health ‐ Addiction PRIMARY OUTCOME: 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.[Phosphatidylethanol (Peth) Test administed at baseline and end of treatment, Self‐report measure of drinking habits throughout study (Timeline Follow‐Back) used to measure number of heavy drinking days. Timeline Follow‐Back used primrily, PEth data used to confirm whether heavy drinking has occurred, according to biological data. 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: Anxiety ; [Overall Anxiety Severity and Impairment Scale (OASIS) test Baseline, Weeks 6 (mid treatment), 12 (end of treatment), 24 (12 weeks from end of treatment)] Depression [Montgomery‐Åsberg Depression Rating Scale (MADRS) Baseline, Weeks 6 (mid treatment), 12 (end of treatment), 24 (12 weeks from end of treatment)] PTSD [Programmable Logic Controllers 5 (PCL‐5) test for PTSD Baseline, Weeks 6 (mid treatment), 12 (end of treatment), 24 (12 weeks from end of treatment)] quality of life [Short Form Survey (SF‐36) ; Baseline, Weeks 6 (mid treatment), 12 (end of treatment), 24 (12 weeks from end of treatment)] Sleep disturbance [Pittsburgh Sleep Quality Inde X(PSQI) Baseline, Weeks 6 (mid treatment), 12 (end of treatment), 24 (12 weeks from end of treatment)] Social phobia [Social Phobia Scale (SPS) Baseline, Weeks 6 (mid treatment), 12 (end of treatment), 24 (12 weeks from end of treatment)] 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