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N-acetylcysteine in Alcohol Dependence

This study has been completed.
Sponsor:
Collaborator:
Minnesota Veterans Research Institute
Information provided by (Responsible Party):
Gihyun Yoon, Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT00568087
First received: December 4, 2007
Last updated: April 22, 2013
Last verified: April 2013
History of Changes
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: N-acetylcysteine in Alcohol Dependence

Resource links provided by NLM:

MedlinePlus related topics: Alcohol Alcoholism
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 ]

Enrollment: 46
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
Active Comparator: 1 Drug: N-acetylcysteine
Oral N-acetylcysteine daily for 8 weeks
Placebo Comparator: 2 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: Gihyun Yoon, Psychiatrist, Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT00568087     History of Changes
Other Study ID Numbers: Protocol #3852-B
Study First Received: December 4, 2007
Last Updated: April 22, 2013
Health Authority: United States: Federal Government

Keywords provided by Minneapolis Veterans Affairs Medical Center:
N-acetylcysteine
Alcoholism
Treatment

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
 Pharmacologic Actions
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes

ClinicalTrials.gov processed this record on June 17, 2013