Back to resultsN-acetylcysteine in Alcohol Dependence
Primary Purpose
Alcoholism
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
N-acetylcysteine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Alcoholism focused on measuring N-acetylcysteine, Alcoholism, Treatment
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
Sites / Locations
- Minneapolis VA Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
N-acetylcysteine
Placebo
Arm Description
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.
Patients will take oral placebo (identical matching placebo) during the study period.
Outcomes
Primary Outcome Measures
Alcohol Consumption (Percentage of Heavy Drinking Days)
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
The Penn Alcohol Craving Scale
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.
The Obsessive Compulsive Drinking Scale
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.
Liver Function Tests
Aspartate aminotransaminase (AST) plasma level
Full Information
NCT ID
NCT00568087
First Posted
December 4, 2007
Last Updated
March 13, 2020
Sponsor
Minneapolis Veterans Affairs Medical Center
Collaborators
Minnesota Veterans Medical Research and Education Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00568087
Brief Title
N-acetylcysteine in Alcohol Dependence
Official Title
N-acetylcysteine in Alcohol Dependence
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minneapolis Veterans Affairs Medical Center
Collaborators
Minnesota Veterans Medical Research and Education Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism
Keywords
N-acetylcysteine, Alcoholism, Treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
N-acetylcysteine
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients will take oral placebo (identical matching placebo) during the study period.
Intervention Type
Drug
Intervention Name(s)
N-acetylcysteine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patients will take oral placebo (identical matching placebo) during the study period.
Primary Outcome Measure Information:
Title
Alcohol Consumption (Percentage of Heavy Drinking Days)
Description
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.
Time Frame
The percentage of heavy drinking days (HDD) was measured at each weekly visit during the 8 weeks.
Secondary Outcome Measure Information:
Title
The Penn Alcohol Craving Scale
Description
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.
Time Frame
The Penn Alcohol Craving Scale was measured at each weekly visit during the 8 weeks.
Title
The Obsessive Compulsive Drinking Scale
Description
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.
Time Frame
The Obsessive Compulsive Drinking Scale was measured at each weekly visit during the 8 weeks.
Title
Liver Function Tests
Description
Aspartate aminotransaminase (AST) plasma level
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gihyun Yoon, MD
Organizational Affiliation
Minneapolis Veterans Affairs Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Minneapolis VA Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
12. IPD Sharing Statement
Learn more about this trial
N-acetylcysteine in Alcohol Dependence
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