Influence of n-Acetylcysteine Maintenance on Alcohol Effects
NCT ID: NCT03216954
Last Updated: 2021-01-26
Study Results
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View full resultsBasic Information
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COMPLETED
EARLY_PHASE1
14 participants
INTERVENTIONAL
2017-09-15
2020-04-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
TRIPLE
Study Groups
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Placebo
Subjects will receive oral placebo capsules two times daily.
Alcohol
During each arm, subjects will receive doses of alcohol, designed to raise BALs to 0.015 and 0.03 g/dl.
Placebos
Subjects will receive placebo capsules
Low Dose n-Acetylcysteine
Subjects will receive 0.6 g oral n-acetylcysteine two times daily.
Alcohol
During each arm, subjects will receive doses of alcohol, designed to raise BALs to 0.015 and 0.03 g/dl.
N-acetyl cysteine
Subjects will receive n-acetyl cysteine capsules
High Dose n-Acetylcysteine
Subjects will receive 1.2 g oral n-acetylcysteine two times daily.
Alcohol
During each arm, subjects will receive doses of alcohol, designed to raise BALs to 0.015 and 0.03 g/dl.
N-acetyl cysteine
Subjects will receive n-acetyl cysteine capsules
Interventions
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Alcohol
During each arm, subjects will receive doses of alcohol, designed to raise BALs to 0.015 and 0.03 g/dl.
Placebos
Subjects will receive placebo capsules
N-acetyl cysteine
Subjects will receive n-acetyl cysteine capsules
Eligibility Criteria
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Inclusion Criteria
* not seeking treatment at the time of the study
* one binge drinking episode (5+/4+ standard alcoholic drinks per drinking session for men and women, respectively) in the past 30 days
* recent alcohol use verified by ethyl glucuronide positive urine, as well as fulfillment of DSM-5 diagnostic criteria for alcohol use disorder
* ECG within normal limits
* otherwise healthy
* body mass index of 19-35
* females using an effective form of birth control and not pregnant or breast feeding
* judged by the medical staff to be psychiatrically and physically healthy
* able to abstain from alcohol for 12 hours prior to session
* no contraindications/allergies to n-acetylcysteine
21 Years
55 Years
ALL
Yes
Sponsors
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National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIH
William Stoops
OTHER
Responsible Party
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William Stoops
Professor
Principal Investigators
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William W Stoops, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Kentucky
Locations
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University of Kentucky
Lexington, Kentucky, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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BED IN 34
Identifier Type: -
Identifier Source: org_study_id
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