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: August 28, 2013
Last verified: August 2013
  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:


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

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Liver Function Tests [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Alcohol Craving (Penn Alcohol Craving Scale) [ Time Frame: Alcohol craving (Penn Alcohol Craving Scale) was measured at each weekly visit during the 8 weeks. ] [ Designated as safety issue: No ]

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


  • Alcohol Craving (Obsessive Compulsive Drinking Scale) [ Time Frame: Alcohol craving (Obsessive Compulsive Drinking Scale) was measured at each weekly visit during the 8 weeks. ] [ Designated as safety issue: No ]

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



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: N-acetylcysteine
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.
Drug: N-acetylcysteine
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.
Other Name: N-acetylcysteine
Placebo Comparator: Placebo
Patients will take oral placebo (identical matching placebo) during the study period.
Drug: Placebo
Patients will take oral placebo (identical matching placebo) during the study period.
Other Name: 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Results First Received: June 14, 2013
Last Updated: August 28, 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
Chemically-Induced 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 October 19, 2014