The Efficacy and Neurobehavioural Mechanism of N-acetyl Cysteine (NAC) for Alcohol Dependence

• Status: Unknown status
• Trial end date: 2020-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The study will explore the efficacy and tolerability of a regimen of NAC (2400 mg) versus placebo for the treatment of alcohol dependence.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: South West Sydney Local Health District
• Collaborators: National Health and Medical Research Council, Australia; University of Sydney
• Treatments: Acetylcysteine; N-monoacetylcystine

Criteria

Inclusion Criteria:

• Male and female patients between the ages of 18 and 65 meeting DSM-IV criteria for current alcohol use disorder (this is an exclusion for the healthy control sample)

• Able to understand and sign written informed consent

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

• Admitted for medical detoxification from alcohol (withdrawal study only)

• Blood alcohol concentration of 0.00 (if completing brain imaging session)

• Express a desire to achieve abstinence or to greatly reduce alcohol consumption (relapse prevention study only)

Exclusion Criteria:

• Clinically significant comorbidities or medical disease that might interfere with the evaluation of the study medication or present a safety concern.

• Pregnant women and women of childbearing potential who do not practice a medically acceptable form of birth control

• Women who are breastfeeding

• Dependence on any substance other than nicotine

• Court-mandated participation in alcohol treatment or pending incarceration (relapse prevention study only)

• Treatment/ingestion during the previous week of benzodiazepines or other sedative-hypnotic medications or history of recent chronic treatment with sedative-hypnotic medications (withdrawal study only)

• Dependence on any substance other than nicotine

The following exclusion criteria are only applicable to participants undergoing the brain imaging session:

• Extreme obesity

• Pregnant or have any reason to believe they are pregnant;

• Previous brain surgery;

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

• Epilepsy

• 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.