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OpenTrials
Completed

NCT Number: NCT03216954

Influence of n-Acetylcysteine Maintenance on Alcohol Effects

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

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Key information

Conditions

Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Kentucky

Lexington, Kentucky, 40507, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alcohol

Drug

During each arm, subjects will receive doses of alcohol, designed to raise BALs to 0.015 and 0.03 g/dl.

Placebos

Drug

Subjects will receive placebo capsules

N-acetyl cysteine

Drug

Subjects will receive n-acetyl cysteine capsules

Primary outcomes

  1. Number of Alcohol Drinks Chosen

    Time frame: After at least four days of placebo or n-acetylcysteine maintenance

    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.

Sponsors and collaborators

Lead sponsor

William Stoops

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jul 13, 2017
Registry last updated
Jan 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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