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NCT03216954 Clinical Trial

Influence of n-Acetylcysteine Maintenance on Alcohol Effects

Alcohol Use Disorder Clinical Trial

Official title:
A Human Laboratory Study of n-Acetylcysteine for Alcohol Use Disorder

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03216954
Other study ID # BED IN 34
Secondary ID R21AA026129
Status Completed
Phase Early Phase 1
First received
Last updated
Start date September 15, 2017
Est. completion date April 23, 2020

Study information
Verified date January 2021
Source University of Kentucky
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will evaluate the behavioral effects of alcohol during placebo and n-acetylcysteine maintenance using sophisticated human laboratory methods.

Recruitment information / eligibility
Status Completed
Enrollment 14
Est. completion date April 23, 2020
Est. primary completion date April 23, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 55 Years
Eligibility Inclusion Criteria: - able to speak/read English - 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 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

Locations
Country Name City State
United States University of Kentucky Lexington Kentucky

Sponsors (2)
Lead Sponsor Collaborator
William Stoops National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Alcohol Drinks Chosen The reinforcing effects of alcohol were determined using a self-administration procedure in which subjects choose to take previously sampled doses. Reinforcing effects are measured during maintenance on placebo and n-acetylcysteine. After at least four days of placebo or n-acetylcysteine maintenance
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