Phase 2 N=46 Randomized Quadruple-blind Treatment

N-acetylcysteine in Alcohol Dependence

Alcoholism

Bottom Line

View on ClinicalTrials.gov: NCT00568087 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2013

Primary outcome: Primary: Alcohol Consumption (Percentage of Heavy Drinking Days) — 70.2; 58.4; 20.2; 14.7 percentage of heavy drinking days

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: N-acetylcysteine (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Minneapolis Veterans Affairs Medical Center
Primary completion: Aug 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Alcohol Consumption (Percentage of Heavy Drinking Days)	70.2; 58.4; 20.2; 14.7	—
SECONDARY The Penn Alcohol Craving Scale	18.1; 18.0; 7.2; 11.5	—
SECONDARY The Obsessive Compulsive Drinking Scale	29.0; 27.6; 13.8; 17.0	—
SECONDARY Liver Function Tests	40.89; 35.85; 26.13; 31.53	—

Summary

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

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00568087). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.