N-acetylcysteine Plus Naltrexone for the Treatment of Alcohol Dependence

VA Office of Research and Development

Status and phase: Completed; Phase 2

Conditions: Alcoholism

Treatments: Drug: Low-dose naltrexone (50 mg) alone; Drug: N-acetylcysteine + high-dose naltrexone (150 mg); Drug: High-dose naltrexone (150 mg) alone

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01214083

CDA-2-014-09F

Details and patient eligibility

About

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.

Full 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.

Enrollment: 111 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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111 participants in 3 patient groups

Arm 1

Experimental group

Description:

N-acetylcysteine + high-dose naltrexone (150 mg)

Treatment:

Drug: N-acetylcysteine + high-dose naltrexone (150 mg)

Arm 2

Experimental group

Description:

High-dose naltrexone (150 mg) alone

Treatment:

Drug: High-dose naltrexone (150 mg) alone

Arm 3

Active Comparator group

Description:

Low-dose naltrexone (50 mg) alone

Treatment:

Drug: Low-dose naltrexone (50 mg) alone