The Efficacy and Neurobehavioural Mechanism of N-acetyl Cysteine for Alcohol Dependence: An Exploratory Pilot Study
Overview
- Phase
- Phase 2
- Intervention
- NAC 2400mg/day
- Conditions
- Alcohol Dependence
- Sponsor
- South West Sydney Local Health District
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Study 3: Markers of neural inflammation and responses to alcohol cue
- Last Updated
- 7 years ago
Overview
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.
Investigators
Professor Paul Haber
Clinical Director
South West Sydney Local Health District
Eligibility 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;
Arms & Interventions
Arm 1
NAC - Relapse Prevention (4 wks)
Intervention: NAC 2400mg/day
Arm 2
NAC - Relapse Prevention (4 wks)
Intervention: Placebo
Outcomes
Primary Outcomes
Study 3: Markers of neural inflammation and responses to alcohol cue
Time Frame: 4 weeks
as measured by blood oxygen level dependent (BOLD) brain activation differences to alcohol cues (alcohol cue activation)
Study 1: Alcohol consumption
Time Frame: 4 weeks
as measured by the abstinence rate, time to relapse and time to lapse
Study 2: Amount of Benzodiazepines administered
Time Frame: 3 days
as measured by Alcohol Urge Questionaire (AUQ) Score
Secondary Outcomes
- Alcohol craving(4 weeks)
- Mood(4 weeks)