N-acetylcysteine Plus Naltrexone for the Treatment of Alcohol Dependence

Completed · Phase 2

Conditions studied: Alcoholism

In brief

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.

Key facts

Study ID

NCT01214083

Run by

VA Office of Research and Development

People needed

111

Starts

2010-10-15

Expected to finish

2016-10-30

Last updated by the study team

2020-04-08

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• VA Connecticut Healthcare System West Haven Campus, West Haven, CT — West Haven, Connecticut, United States
• Minneapolis VA Health Care System, Minneapolis, MN — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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