Examining How a Novel Medication Modulates the Brain, Body and Alcohol Craving

Researchers at the Royal Prince Alfred Hospital are conducting a project to examine how an investigational study drug modulates the brain and body and how these effects might serve to regulate craving to alcohol.

Eligibility

 

INCLUSION CRITERIA:

  • Male and female patients between the ages of 18 and 65 meeting DSM-V 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 (eg 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. 

  • CIWA-Ar score of >10 (refer for treatment as appropriate and will not enter the study.)

How to participate

If you are interested in participating please follow this link and add your contact information

https://redcap.sydney.edu.au/surveys/?s=TR998REWJTMRPWLE