N-Acetylcysteine in Alcohol Dependence - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

December 4, 2007

Last Updated Date

January 14, 2009

Start Date ^†

December 2007

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00568087 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

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

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

N-Acetylcysteine in Alcohol Dependence

Official Title ^†

N-Acetylcysteine in Alcohol Dependence

Brief Summary

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

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.

Study Phase

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

Condition ^†

Alcoholism

Intervention ^†

Drug: N-acetylcysteine
Drug: Placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

Estimated Completion Date

June 2009

Estimated Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Eligibility 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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^††

Contact: Gihyun Yoon, MD

612-467-3996

gihyun.yoon@va.gov

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00568087

Responsible Party

Gihyun Yoon, MD, Minneapolis VAMC

Secondary IDs ^††

Study Sponsor ^†

Minneapolis Veterans Affairs Medical Center

Collaborators ^††

Minnesota Veterans Research Institute

Investigators ^†

Principal Investigator:

Gihyun Yoon, MD

Minneapolis Veterans Affairs Medical Center

Information Provided By

Minneapolis Veterans Affairs Medical Center

Verification Date

January 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.