Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
46 participants
INTERVENTIONAL
2007-12-31
2009-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
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.
Placebo
Patients will take oral placebo (identical matching placebo) during the study period.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* alcohol dependence by DSM-IV
* heavy drinking at least 4 times in the past month
* able to provide informed consent
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Minnesota Veterans Medical Research and Education Foundation
OTHER
Minneapolis Veterans Affairs Medical Center
FED
Responsible Party
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Gihyun Yoon
Psychiatrist
Principal Investigators
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Gihyun Yoon, MD
Role: PRINCIPAL_INVESTIGATOR
Minneapolis Veterans Affairs Medical Center
Locations
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Minneapolis VA Medical Center
Minneapolis, Minnesota, United States
Countries
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Other Identifiers
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Protocol #3852-B
Identifier Type: -
Identifier Source: org_study_id
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