Status:
UNKNOWN
The Efficacy and Neurobehavioural Mechanism of Cannabidiol (CBD) for Alcohol Dependence
Lead Sponsor:
South West Sydney Local Health District
Collaborating Sponsors:
University of Sydney
Lambert Initiative for Cannabinoid Therapeutics
Conditions:
Alcohol Use Disorder (AUD)
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The study will explore the psychophysiological and neurobiological and mechanisms of CBD in participants with alcohol use disorder
Detailed Description
New treatment strategies for treating symptoms of alcohol dependence are urgently needed. Although alcohol related disorders are a leading cause of preventable death in Australia, their treatment is g...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05387148
Start Date
June 1 2022
End Date
June 1 2024
Last Update
June 3 2022
Active Locations (1)
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1
Drug Health Services, Royal Prince Alfred Hospital
Sydney, New South Wales, Australia, 2050