This trial is active, not recruiting.

Condition alcoholism
Treatments n-acetylcysteine + high-dose naltrexone (150 mg), high-dose naltrexone (150 mg) alone, low-dose naltrexone (50 mg) alone
Phase phase 2
Sponsor VA Office of Research and Development
Start date October 2010
End date September 2015
Trial size 150 participants
Trial identifier NCT01214083, CDA-2-014-09F


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
N-acetylcysteine + high-dose naltrexone (150 mg)
n-acetylcysteine + high-dose naltrexone (150 mg)
All subjects will be evaluated weekly for 12 weeks.
High-dose naltrexone (150 mg) alone
high-dose naltrexone (150 mg) alone
All subjects will be evaluated weekly for 12 weeks.
(Active Comparator)
Low-dose naltrexone (50 mg) alone
low-dose naltrexone (50 mg) alone
All subjects will be evaluated weekly for 12 weeks.

Primary Outcomes

Percentage of heavy drinking days
time frame: 12 weeks

Secondary Outcomes

Liver function tests
time frame: 12 weeks
Penn Alcohol Craving Scale (PACS)
time frame: 12 weeks
Obsessive Compulsive Drinking Scale (OCDS)
time frame: 12 weeks
Clinical Global Impression (CGI)
time frame: 12 weeks
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
time frame: 12 weeks
percentage of drinking days
time frame: 12 weeks
drinks per drinking days
time frame: 12 weeks

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title N-acetylcysteine Plus Naltrexone for the Treatment of Alcohol Dependence
Principal investigator Gihyun Yoon, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by VA Office of Research and Development.