The Efficacy and Neurobehavioural Mechanism of N-acetyl Cysteine (NAC) for Alcohol Dependence
- Registration Number
- NCT03879759
- Lead Sponsor
- South West Sydney Local Health District
- Brief Summary
The study will explore the efficacy and tolerability of a regimen of NAC (2400 mg) versus placebo for the treatment of alcohol dependence.
- Detailed Description
Study 1: Relapse prevention: This is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive oral NAC (2400 mg: 2x 600mg tablets twice per day) or matching placebo. Trial participants will receive either oral NAC ( dose stated above) or matching placebo for up to 4 weeks.
Study 2: Withdrawal: Trial participants will receive oral NAC (dose stated above) or matching placebo within the first 24 hours of their admission for up to 3 days.
Study 3: Participants from the relapse prevention substudy will also receive 30-minute non-invasive brain imaging session prior to and after completing the treatment regime in Study 1.
Both males and females will be recruited for the study.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
- 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)
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 2 Placebo NAC - Relapse Prevention (4 wks) Arm 1 NAC 2400mg/day NAC - Relapse Prevention (4 wks)
- Primary Outcome Measures
Name Time Method Study 3: Markers of neural inflammation and responses to alcohol cue 4 weeks as measured by blood oxygen level dependent (BOLD) brain activation differences to alcohol cues (alcohol cue activation)
Study 1: Alcohol consumption 4 weeks as measured by the abstinence rate, time to relapse and time to lapse
Study 2: Amount of Benzodiazepines administered 3 days as measured by Alcohol Urge Questionaire (AUQ) Score
- Secondary Outcome Measures
Name Time Method Alcohol craving 4 weeks as measured by Penn Alcohol Craving Scale (PACS) score
Mood 4 weeks as measured by Depression Anxiety Stress Scale (DASS) score
Trial Locations
- Locations (1)
Drug Health Services, Royal Prince Alfred Hospital
🇦🇺Sydney, New South Wales, Australia