Phase 2
N=95
N-acetylcysteine Plus Naltrexone for the Treatment of Alcohol Dependence
Alcoholism
Bottom Line
View on ClinicalTrials.gov: NCT01214083 ↗Enrolled (actual)
95
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: Percentage of Heavy Drinking Days — 45.0; 50.6; 44.0; 5.2 percentage of heavy drinking days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- N-acetylcysteine + high-dose naltrexone (150 mg) (Drug); High-dose naltrexone (150 mg) alone (Drug); Low-dose naltrexone (50 mg) alone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Heavy Drinking Days |
45.0; 50.6; 44.0; 5.2; 3.4; 3.3 | — |
| SECONDARY Liver Function Tests (AST) |
34.7; 29.0; 30.0; 27.3; 32.1; 22.2 | — |
| SECONDARY Penn Alcohol Craving Scale (PACS) |
18.0; 18.4; 16.1; 7.2; 8.3; 6.3 | — |
| SECONDARY Obsessive Compulsive Drinking Scale (OCDS) |
28.2; 29.0; 24.5; 9.1; 14.0; 9.0 | — |
| SECONDARY Clinical Global Impression (CGI) |
3.7; 3.7; 3.6; 1.5; 1.7; 1.4 | — |
| SECONDARY Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) |
53.2; 53.8; 55.1; 61.6; 59.6; 63.9 | — |
| SECONDARY Percentage of Drinking Days |
64.6; 63.8; 55.3; 21.1; 24.5; 18.2 | — |
| SECONDARY Drinks Per Drinking Days |
7.3; 5.9; 7.3; 1.1; 1.2; 1.0 | — |
| SECONDARY Liver Function Tests (ALT) |
49.4; 36.5; 34.7; 27.6; 40.1; 31.3 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01214083). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.