N-acetylcysteine in Alcohol Dependence

Alcoholism Clinical Trial

Official title:

N-acetylcysteine in Alcohol Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00568087
• Other study ID #: Protocol #3852-B
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: December 2007
• Est. completion date: August 2009

Study information

• Verified date: March 2020
• Source: Minneapolis Veterans Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcoholism

Intervention

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.
• Placebo
Patients will take oral placebo (identical matching placebo) during the study period.

Locations

Country	Name	City	State
United States	Minneapolis VA Medical Center	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Minneapolis Veterans Affairs Medical Center	Minnesota Veterans Medical Research and Education Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	Liver Function Tests	Aspartate aminotransaminase (AST) plasma level	8 weeks