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
• 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
• 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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism

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