N-acetylcysteine in Alcohol Dependence

Phase 1

Completed

Brief Summary: The present study is designed to find out if N-acetylcysteine works in reducing alcohol drinking and craving.

Detailed Description: The 2 groups (placebo and N-acetylcysteine) will be compared in a double-blind, placebo-controlled trial. The total study duration is 9 weeks which includes a 1-week screening period and an 8-week randomized study drug treatment period.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

current drug abuse or dependence by DSM-IV criteria (except nicotine or cannabis)
current psychotic disorders, bipolar disorders, or cognitive disorders
current suicidal or homicidal ideation
positive illicit drug screen (except cannabis)
Clinical Institute Withdrawal Assessment for Alcohol, Revised >15
initiation of individual therapy or counseling in the past 3 months
changes in doses of psychiatric medications in the past 3 months
clinically unstable cardiac, hepatic, renal, neurologic, or pulmonary disease
current use of naltrexone, disulfiram or acamprosate
pregnant or nursing women, or inadequate birth control methods in women of childbearing potential

Arm && Interventions

Group	Intervention	Description
N-acetylcysteine	N-acetylcysteine	Patients will take oral N-acetylcysteine 900 mg/day for 1 week, 1800 mg/day for 1 week, 2700 mg/day for 1 week, and then 3600 mg/day.
Placebo	Placebo	Patients will take oral placebo (identical matching placebo) during the study period.

Primary Outcome Measures

Name	Time	Method
Alcohol Consumption (Percentage of Heavy Drinking Days)	The percentage of heavy drinking days (HDD) was measured at each weekly visit during the 8 weeks.	The percentage of heavy drinking days was primary a priori outcome measure. Heavy drinking was defined as ≥ 5 standard drinks per day for men and ≥ 4 standard drinks for women. One standard drink is any drink containing about 0.6 fluid ounces or 14 grams of pure alcohol. The percentage of heavy drinking days (HDD) was measured at each weekly visit during the 8 weeks--from week 1 (before starting intervention) to week 9 (after completing intervention). At each week, the percentage of HDD was calculated during the period (usually 7 days) since the last previous visit.

Secondary Outcome Measures

Name	Time	Method
The Penn Alcohol Craving Scale	The Penn Alcohol Craving Scale was measured at each weekly visit during the 8 weeks.	Alcohol craving was secondary a priori outcome measure. Alcohol craving was measured at each weekly visit during the 8 weeks--from week 1 (before starting intervention) to week 9 (after completing intervention). The Penn Alcohol Craving Scale is a self-rated scale designed to assess alcohol craving. The score range of the Penn Alcohol Craving Scale is between 0 and 30, with 30 assigned to the highest (worst) alcohol craving.
The Obsessive Compulsive Drinking Scale	The Obsessive Compulsive Drinking Scale was measured at each weekly visit during the 8 weeks.	Alcohol craving was secondary a priori outcome measure. Alcohol craving was measured at each weekly visit during the 8 weeks--from week 1 (before starting intervention) to week 9 (after completing intervention). The Obsessive Compulsive Drinking Scale is a self-rated scale designed to assess alcohol craving. The score range of the Obsessive Compulsive Drinking Scale is between 0 and 56, with 56 assigned to the highest (worst) alcohol craving.
Liver Function Tests	8 weeks	Aspartate aminotransaminase (AST) plasma level