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Completed

NCT Number: NCT01214083

N-acetylcysteine Plus Naltrexone for the Treatment of Alcohol Dependence

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.

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Key information

Conditions

Alcoholism Alcohol-Related Disorders Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

VA Connecticut Healthcare System West Haven Campus, West Haven, CT, West Haven, Connecticut, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

All subjects will be evaluated weekly for 12 weeks.

High-dose naltrexone (150 mg) alone

Drug

All subjects will be evaluated weekly for 12 weeks.

Low-dose naltrexone (50 mg) alone

Drug

All subjects will be evaluated weekly for 12 weeks.

Primary outcomes

  1. Percentage of Heavy Drinking Days

    Time frame: 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 outcomes

  1. Liver Function Tests (AST)

    Time frame: week 0 and week 13

  2. Penn Alcohol Craving Scale (PACS)

    Time frame: 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).

  3. Obsessive Compulsive Drinking Scale (OCDS)

    Time frame: 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).

  4. Clinical Global Impression (CGI)

    Time frame: 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).

  5. Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)

    Time frame: 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).

  6. Percentage of Drinking Days

    Time frame: 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).

  7. Drinks Per Drinking Days

    Time frame: week 1 and week 13

  8. Liver Function Tests (ALT)

    Time frame: week 0 and week 13

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Important dates

Study start
2010
Primary completion
2015
Study completion
2016
First posted
Oct 4, 2010
Registry last updated
Apr 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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