The Efficacy and Neurobehavioural Mechanism of Cannabidiol (CBD) for Alcohol Dependence

• Status: Recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The study will explore the psychophysiological and neurobiological and mechanisms of CBD in participants with alcohol use disorder

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: South West Sydney Local Health District
• Collaborators: Lambert Initiative for Cannabinoid Therapeutics; University of Sydney
• Treatments: Cannabidiol

Criteria

Inclusion Criteria:

• Male and female patients between ages of 18 and 65 meeting DSM-5 criteria for current alcohol use disorder

• Adequate cognition and English language skills to give valid consent and complete research interviews;

• A BrAC reading of 0.00

• Must have a stable residence and be able to identify an individual who could locate subject if needed

• Provision of informed consent

Exclusion Criteria:

• Active major psychological disorder associated with psychosis, significant suicide risk

• Pregnancy or lactation - women shall be advised to use reliable contraception for the duration of drug therapy and a urine pregnancy test will be performed where necessary;

• Dependence on any substance other than nicotine (eg methadone)

• Diagnosis of epilepsy, and/or current use of anti-epileptic drugs (AED)

• Liver failure with jaundice or prolonged INR above 1.3

• Medical complications such as liver failure, cardiac ischemia or conduction abnormalities, renal impairment or unstable elevated vital signs (systolic blood pressure > 180, diastolic blood pressure > 120 or heart rate > 150)

• Severe cognitive impairment or insufficient English or literacy to complete study processes

• Concurrent use of drugs potentially exacerbated by CBD via CYP3A5 including cardiac medication (e.g. betablockers, calcium channel blockers and statins), macrolides and recent antihistamine use.

• Claustrophobia;

• Extreme obesity;

• Previous brain surgery;

• Ever employed as a machinist, a welder or a metal worker;

• Metal items such as pacemakers; aneurysm clips in the brain; metal dental implants; metallic fragments in the eye or anywhere else; insulin pump; metal implants; hearing aid or a prosthetic device.