N-acetylcysteine Plus Naltrexone for the Treatment of Alcohol Dependence

• Status: Completed
• Trial end date: 2016-10-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether: (1) the combination of N-acetylcysteine + high-dose naltrexone (150 mg) works better than high-dose naltrexone (150 mg) alone in reducing alcohol drinking; and (2) high-dose naltrexone (150 mg) alone works better than low-dose naltrexone (50 mg) alone in reducing alcohol drinking.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Office of Research and Development
• Treatments: Acetylcysteine; N-monoacetylcystine; Naltrexone

Criteria

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