N-acetylcysteine in Alcohol Dependence

Minneapolis Veterans Affairs Health Care System (VAHCS)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Alcoholism

Treatments: Drug: N-acetylcysteine; Drug: Placebo

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT00568087

Protocol #3852-B

Details and patient eligibility

About

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

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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46 participants in 2 patient groups, including a placebo group

N-acetylcysteine

Active Comparator group

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.

Treatment:

Drug: N-acetylcysteine

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo