N-acetylcysteine in Alcohol Dependence

This study has been completed.

First Received: December 4, 2007 Last Updated: September 24, 2009 History of Changes

Sponsor:	Minneapolis Veterans Affairs Medical Center
Collaborator:	Minnesota Veterans Research Institute
Information provided by:	Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:	NCT00568087

Purpose

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

Condition	Intervention	Phase
Alcoholism	Drug: N-acetylcysteine Drug: Placebo	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	N-acetylcysteine in Alcohol Dependence

Resource links provided by NLM:

MedlinePlus related topics: Alcohol Alcoholism

Drug Information available for: Acetylcysteine

U.S. FDA Resources

Further study details as provided by Minneapolis Veterans Affairs Medical Center:

Primary Outcome Measures:

Alcohol consumption [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Liver function tests [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	December 2007
Study Completion Date:	August 2009
Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: N-acetylcysteine Oral N-acetylcysteine daily for 8 weeks
2: Placebo Comparator	Drug: Placebo Placebo

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00568087

Locations

United States, Minnesota
Minneapolis VA Medical Center
Minneapolis, Minnesota, United States, 55417

Sponsors and Collaborators

Minneapolis Veterans Affairs Medical Center

Minnesota Veterans Research Institute

Investigators

Principal Investigator:

Gihyun Yoon, MD

Minneapolis Veterans Affairs Medical Center

More Information

No publications provided

Responsible Party:	Minneapolis VAMC ( Gihyun Yoon, MD )
Study ID Numbers:	Protocol #3852-B
Study First Received:	December 4, 2007
Last Updated:	September 24, 2009
ClinicalTrials.gov Identifier:	NCT00568087 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Minneapolis Veterans Affairs Medical Center:

N-acetylcysteine
Alcoholism
Treatment

Additional relevant MeSH terms:

Acetylcysteine
N-monoacetylcystine
Anti-Infective Agents
Respiratory System Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Disorders of Environmental Origin
Protective Agents
Antiviral Agents

Pharmacologic Actions
Mental Disorders
Expectorants
Therapeutic Uses
Alcoholism
Free Radical Scavengers
Substance-Related Disorders
Alcohol-Related Disorders
Antidotes

ClinicalTrials.gov processed this record on November 20, 2009