Influence of n-Acetylcysteine Maintenance on Alcohol Effects

Early Phase 1

Completed

• Conditions: Alcohol Use Disorder
• Interventions: Drug: Alcohol; Drug: Placebos; Drug: N-acetyl cysteine

• Registration Number: NCT03216954
• Lead Sponsor: William Stoops

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-07
• Study First Submitted QC: 2017-07-11
• Study First Posted: 2017-07-13
• Study Start: 2017-09-15
• Primary Completion: 2020-04-23
• Study Completion: 2020-04-23
• Results First Submitted: 2020-12-07
• Status Verified: 2021-01
• Results First Submitted QC: 2021-01-05
• Last Update Submitted: 2021-01-05
• Results First Posted: 2021-01-26
• Last Update Posted: 2021-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebos	Subjects will receive oral placebo capsules two times daily.
Low Dose n-Acetylcysteine	N-acetyl cysteine	Subjects will receive 0.6 g oral n-acetylcysteine two times daily.
High Dose n-Acetylcysteine	N-acetyl cysteine	Subjects will receive 1.2 g oral n-acetylcysteine two times daily.
Placebo	Alcohol	Subjects will receive oral placebo capsules two times daily.
Low Dose n-Acetylcysteine	Alcohol	Subjects will receive 0.6 g oral n-acetylcysteine two times daily.
High Dose n-Acetylcysteine	Alcohol	Subjects will receive 1.2 g oral n-acetylcysteine two times daily.

Primary Outcome Measures

Name	Time	Method
Number of Alcohol Drinks Chosen	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.

Trial Locations

Locations (1)

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States