N-acetylcysteine Plus Naltrexone for the Treatment of Alcohol Dependence

Phase 2

Completed

• Conditions: Alcoholism
• Interventions: Drug: Low-dose naltrexone (50 mg) alone; Drug: N-acetylcysteine + high-dose naltrexone (150 mg); Drug: High-dose naltrexone (150 mg) alone

• Registration Number: NCT01214083
• Lead Sponsor: VA Office of Research and Development

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 drinking; and (2) high-dose naltrexone (150 mg) alone works better than low-dose naltrexone (50 mg) alone in reducing alcohol drinking.

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2010-09-30
• Study First Submitted QC: 2010-09-30
• Study First Posted: 2010-10-04
• Study Start: 2010-10-15
• Primary Completion: 2015-09-30
• Study Completion: 2016-10-30
• Results First Submitted: 2016-12-12
• Results First Submitted QC: 2017-02-07
• Results First Posted: 2017-03-28
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-31
• Last Update Posted: 2020-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 3	Low-dose naltrexone (50 mg) alone	Low-dose naltrexone (50 mg) alone
Arm 1	N-acetylcysteine + high-dose naltrexone (150 mg)	N-acetylcysteine + high-dose naltrexone (150 mg)
Arm 2	High-dose naltrexone (150 mg) alone	High-dose naltrexone (150 mg) alone

Primary Outcome Measures

Name	Time	Method
Percentage of Heavy Drinking Days	week 1 and week 13	"Percentage of heavy drinking days" was measured by the Time Line Follow Back (TLFB) Method. ('Heavy drinking' was defined as 5 or more standard drinks per day for men and 4 or more standard drinks for women.) The percentage has a total range of 0%-100%. Higher percentages represent a worse outcome (i.e., more heavy drinking).

Secondary Outcome Measures

Name	Time	Method
Liver Function Tests (ALT)	week 0 and week 13
Liver Function Tests (AST)	week 0 and week 13
Clinical Global Impression (CGI)	week 1 and week 13	The Clinical Global Impression is designed to assess overall severity of illness. The scale has a total score range of 1-7. Higher values represent a worse outcome (i.e., severe illness).
Percentage of Drinking Days	week 1 and week 13	"Percentage of drinking days" was measured by the Time Line Follow Back (TLFB) Method. The percentage has a total range of 0%-100%. Higher percentages represent a worse outcome (i.e., more drinking days).
Penn Alcohol Craving Scale (PACS)	week 1 and week 13	The Penn Alcohol Craving Scale is designed to assess alcohol craving severity. The scale has a total score range of 0-30. Higher values represent a worse outcome (i.e., higher craving).
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)	week 1 and week 13	The Quality of Life Enjoyment and Satisfaction Questionnaire is designed to assess a quality of life. The scale has a total score range of 16-80. Higher values represent a better outcome (i.e., better quality of life).
Drinks Per Drinking Days	week 1 and week 13
Obsessive Compulsive Drinking Scale (OCDS)	week 1 and week 13	The Obsessive Compulsive Drinking Scale is designed to assess obsessive and compulsive aspects of alcoholism. The scale has a total score range of 0-56. Higher values represent a worse outcome (i.e., more alcohol problems).

Trial Locations

Locations (2)

Minneapolis VA Health Care System, Minneapolis, MN; 🇺🇸 Minneapolis, Minnesota, United States

VA Connecticut Healthcare System West Haven Campus, West Haven, CT; 🇺🇸 West Haven, Connecticut, United States