The study will explore the efficacy and tolerability of a regimen of NAC (2400 mg) versus placebo for the treatment of alcohol dependence.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
2400mg/day 2 x 600mg b.d
4 matched placebo tablets/day
Drug Health Services, Royal Prince Alfred Hospital
Sydney, New South Wales, Australia
RECRUITINGStudy 1: Alcohol consumption
as measured by the number of heavy drinking days per week and number of drinks per drinking day
Time frame: 4 weeks
Study 1: Alcohol consumption
as measured by the abstinence rate, time to relapse and time to lapse
Time frame: 4 weeks
Study 2: Amount of Benzodiazepines administered
as measured by the number of benzodiazepines administered in the NAC vs placebo groups
Time frame: 3 days
Study 2: Amount of Benzodiazepines administered
as measured by Alcohol Withdrawal Scale (AWS) score
Time frame: 3 days
Study 2: Amount of Benzodiazepines administered
as measured by Visual Analogue Scale (VAS) score
Time frame: 3 days
Study 2: Amount of Benzodiazepines administered
as measured by Alcohol Urge Questionaire (AUQ) Score
Time frame: 3 days
Study 3: Markers of neural inflammation and responses to alcohol cue
as measured by differences in cortical levels of glutathione
Time frame: 4 weeks
Study 3: Markers of neural inflammation and responses to alcohol cue
as measured by differences in cortical levels of N-acetylaspartate
Time frame: 4 weeks
Study 3: Markers of neural inflammation and responses to alcohol cue
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as measured by blood oxygen level dependent (BOLD) brain activation differences to alcohol cues (alcohol cue activation)
Time frame: 4 weeks
Alcohol craving
as measured by Penn Alcohol Craving Scale (PACS) score
Time frame: 4 weeks
Mood
as measured by Depression Anxiety Stress Scale (DASS) score
Time frame: 4 weeks