Status:
COMPLETED
N-acetylcysteine Plus Naltrexone for the Treatment of Alcohol Dependence
Lead Sponsor:
VA Office of Research and Development
Conditions:
Alcoholism
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 dri...
Detailed 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 15 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2016
Estimated Enrollment :
111 Patients enrolled
Trial Details
Trial ID
NCT01214083
Start Date
October 15 2010
End Date
October 30 2016
Last Update
April 8 2020
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, United States, 06516
2
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, United States, 55417