N-acetylcysteine in Alcohol Dependence

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

Detailed Description
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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.

Official Title
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N-acetylcysteine in Alcohol Dependence

Conditions
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Alcoholism

Intervention / Treatment
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* Drug: N-acetylcysteine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: N-acetylcysteine<br>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<br>* 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.<br>|
| Placebo Comparator: Placebo<br>Patients will take oral placebo (identical matching placebo) during the study period. | Drug: Placebo<br>* Patients will take oral placebo (identical matching placebo) during the study period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | The percentage of heavy drinking days (HDD) was measured at each weekly visit during the 8 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Penn Alcohol Craving Scale was measured at each weekly visit during the 8 weeks. | 
| 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. | The Obsessive Compulsive Drinking Scale was measured at each weekly visit during the 8 weeks. | 
| Liver Function Tests | Aspartate aminotransaminase (AST) plasma level | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alcoholism, N-acetylcysteine, Treatment