N-acetylcysteine in Alcohol Dependence
Overview
- Phase
- Phase 1
- Intervention
- N-acetylcysteine
- Conditions
- Alcoholism
- Sponsor
- Minneapolis Veterans Affairs Medical Center
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- Alcohol Consumption (Percentage of Heavy Drinking Days)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Gihyun Yoon
Psychiatrist
Minneapolis Veterans Affairs Medical Center
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
Arms & Interventions
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.
Intervention: N-acetylcysteine
Placebo
Patients will take oral placebo (identical matching placebo) during the study period.
Intervention: Placebo
Outcomes
Primary Outcomes
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.
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 Outcomes
- The Penn Alcohol Craving Scale(The Penn Alcohol Craving Scale was measured at each weekly visit during the 8 weeks.)
- The Obsessive Compulsive Drinking Scale(The Obsessive Compulsive Drinking Scale was measured at each weekly visit during the 8 weeks.)
- Liver Function Tests(8 weeks)