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Completed

NCT Number: NCT00568087

N-acetylcysteine in Alcohol Dependence

The present study is designed to find out if N-acetylcysteine works in reducing alcohol drinking and craving.

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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 1 / Phase 2

Primary location

Minneapolis VA Medical Center

Minneapolis, Minnesota, 55417, United States

About this study

The 2 groups (placebo and N-acetylcysteine) will be compared in a double-blind, placebo-controlled trial. The total study duration is 9 weeks which includes a 1-week screening period and an 8-week randomized study drug treatment period.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age 18 - 65
  • alcohol dependence by DSM-IV
  • heavy drinking at least 4 times in the past month
  • able to provide informed consent

Exclusion criteria

  • current drug abuse or dependence by DSM-IV criteria (except nicotine or cannabis)
  • current psychotic disorders, bipolar disorders, or cognitive disorders
  • current suicidal or homicidal ideation
  • positive illicit drug screen (except cannabis)
  • Clinical Institute Withdrawal Assessment for Alcohol, Revised >15
  • initiation of individual therapy or counseling in the past 3 months
  • changes in doses of psychiatric medications in the past 3 months
  • clinically unstable cardiac, hepatic, renal, neurologic, or pulmonary disease
  • current use of naltrexone, disulfiram or acamprosate
  • pregnant or nursing women, or inadequate birth control methods in women of childbearing potential

Treatment and study plan

N-acetylcysteine

Drug

Patients will take oral N-acetylcysteine 900 mg/day for 1 week, 1800 mg/day for 1 week, 2700 mg/day for 1 week, and then 3600 mg/day.

Placebo

Drug

Patients will take oral placebo (identical matching placebo) during the study period.

Primary outcomes

  1. Alcohol Consumption (Percentage of Heavy Drinking Days)

    Time frame: The percentage of heavy drinking days (HDD) was measured at each weekly visit during the 8 weeks.

    The percentage of heavy drinking days was primary a priori outcome measure. Heavy drinking was defined as ≥ 5 standard drinks per day for men and ≥ 4 standard drinks for women. One standard drink is any drink containing about 0.6 fluid ounces or 14 grams of pure alcohol. The percentage of heavy drinking days (HDD) was measured at each weekly visit during the 8 weeks--from week 1 (before starting intervention) to week 9 (after completing intervention). At each week, the percentage of HDD was calculated during the period (usually 7 days) since the last previous visit.

Secondary outcomes

  1. The Penn Alcohol Craving Scale

    Time frame: The Penn Alcohol Craving Scale was measured at each weekly visit during the 8 weeks.

    Alcohol craving was secondary a priori outcome measure. Alcohol craving was measured at each weekly visit during the 8 weeks--from week 1 (before starting intervention) to week 9 (after completing intervention).

    The Penn Alcohol Craving Scale is a self-rated scale designed to assess alcohol craving. The score range of the Penn Alcohol Craving Scale is between 0 and 30, with 30 assigned to the highest (worst) alcohol craving.

  2. The Obsessive Compulsive Drinking Scale

    Time frame: The Obsessive Compulsive Drinking Scale was measured at each weekly visit during the 8 weeks.

    Alcohol craving was secondary a priori outcome measure. Alcohol craving was measured at each weekly visit during the 8 weeks--from week 1 (before starting intervention) to week 9 (after completing intervention).

    The Obsessive Compulsive Drinking Scale is a self-rated scale designed to assess alcohol craving. The score range of the Obsessive Compulsive Drinking Scale is between 0 and 56, with 56 assigned to the highest (worst) alcohol craving.

  3. Liver Function Tests

    Time frame: 8 weeks

    Aspartate aminotransaminase (AST) plasma level

Sponsors and collaborators

Lead sponsor

Minneapolis Veterans Affairs Medical Center

Fed

Collaborators

  • Minnesota Veterans Medical Research and Education Foundation

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Dec 5, 2007
Registry last updated
Mar 18, 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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