N-acetylcysteine Plus Naltrexone for the Treatment of Alcohol Dependence

The 3 groups (N-acetylcysteine plus naltrexone 150 mg, naltrexone 150 mg, and naltrexone 50
mg) will be compared in a 12-week randomized, double-blind clinical trial.

Inclusion Criteria:

- age 18-65 years

- alcohol dependence by DSM-IV criteria

- heavy drinking at least 6 times within the past month ('heavy drinking' defined as 5
or more standard drinks per day for men and 4 or more standard drinks for women)

- able to provide informed consent

- a score of 6 or more on the Penn Alcohol Craving Scale (PACS)

- subject agrees not to take over-the-counter analgesics during the study

Exclusion Criteria:

- current drug abuse or dependence by DSM-IV criteria (except nicotine and marijuana)

- current psychotic disorders or bipolar disorders

- current suicidal or homicidal ideation

- positive illicit drug screen test (except marijuana)

- ongoing narcotic use or risks for narcotic use during the study

- increased risk for severe alcohol withdrawal by a score of 10 or more on the Clinical
Institute Withdrawal Assessment for Alcohol, Revised (CIWA-Ar)

- clinically significant cardiac, hepatic, renal, neurologic, or pulmonary disease

- baseline aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater
than 3 times normal

- current use of disulfiram, acamprosate or topiramate

- pregnant or nursing, or inadequate birth control methods in women of childbearing
potential

- alcohol breathalyzer level 0.08 or more at the screening visit

- severe alcohol withdrawal (delirium tremens or withdrawal seizures) within the past
year

- currently requiring inpatient treatment for treating alcohol dependence