Clinical trial NCT01214083: N-acetylcysteine Plus Naltrexone for the Treatment of Alcohol Dependence
Official title: N-acetylcysteine Plus Naltrexone for the Treatment of Alcohol Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alcoholism
Keywords: N-acetylcysteine
naltrexone
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2010-10-04
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage of Heavy Drinking Days
timeFrame: week 1 and week 13
Secondary outcomes:
measure: Liver Function Tests (AST)
timeFrame: week 0 and week 13
measure: Penn Alcohol Craving Scale (PACS)
timeFrame: week 1 and week 13
measure: Obsessive Compulsive Drinking Scale (OCDS)
timeFrame: week 1 and week 13
measure: Clinical Global Impression (CGI)
timeFrame: week 1 and week 13
measure: Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
timeFrame: week 1 and week 13
measure: Percentage of Drinking Days
timeFrame: week 1 and week 13
measure: Drinks Per Drinking Days
timeFrame: week 1 and week 13
measure: Liver Function Tests (ALT)
timeFrame: week 0 and week 13
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healthcare System West Haven Campus, West Haven, CT
state: Connecticut
city: Minneapolis
country: United States
facility: Minneapolis VA Health Care System, Minneapolis, MN
state: Minnesota
Study officials:
affiliation: VA Connecticut Healthcare System West Haven Campus, West Haven, CT
name: Gihyun Yoon, MD
role: PRINCIPAL_INVESTIGATOR
References: