Influence of n-Acetylcysteine Maintenance on Alcohol Effects

NCT03216954 | Completed Early Phase 1 Results FDA Drug

• 2 other identifiers: BED IN 34R21AA026129
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Alcohol Use Disorder

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Subjects will receive oral placebo capsules two times daily.

Drug: Alcohol; Drug: Placebos

Low Dose n-Acetylcysteine

EXPERIMENTAL

Subjects will receive 0.6 g oral n-acetylcysteine two times daily.

Drug: Alcohol; Drug: N-acetyl cysteine

High Dose n-Acetylcysteine

EXPERIMENTAL

Subjects will receive 1.2 g oral n-acetylcysteine two times daily.

Drug: Alcohol; Drug: N-acetyl cysteine

Interventions

Alcohol DRUG

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

High Dose n-Acetylcysteine; Low Dose n-Acetylcysteine; Placebo

Placebos DRUG

Subjects will receive placebo capsules

Placebo

N-acetyl cysteine DRUG

Subjects will receive n-acetyl cysteine capsules

High Dose n-Acetylcysteine; Low Dose n-Acetylcysteine

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• William Stoops: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40507, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Ethanol; Acetylcysteine

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: William W. Stoops, PhD
• Organization: University of Kentucky

william.stoops@uky.edu

859-257-5388

Study Officials

• William W Stoops, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 7, 2017
• First Posted: July 13, 2017
• Study Start: September 15, 2017
• Primary Completion: April 23, 2020
• Study Completion: April 23, 2020
• Last Updated: January 26, 2021
• Results First Posted: January 26, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)