Influence of n-Acetylcysteine Maintenance on Alcohol Effects

January 5, 2021 updated by: William Stoops

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40507
        • University Of Kentucky

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Subjects will receive oral placebo capsules two times daily.
Drug: Alcohol
During each arm, subjects will receive doses of alcohol, designed to raise BALs to 0.015 and 0.03 g/dl.
Drug: Placebos
Subjects will receive placebo capsules
EXPERIMENTAL: Low Dose n-Acetylcysteine
Subjects will receive 0.6 g oral n-acetylcysteine two times daily.
Drug: Alcohol
During each arm, subjects will receive doses of alcohol, designed to raise BALs to 0.015 and 0.03 g/dl.
Drug: N-acetyl cysteine
Subjects will receive n-acetyl cysteine capsules
EXPERIMENTAL: High Dose n-Acetylcysteine
Subjects will receive 1.2 g oral n-acetylcysteine two times daily.
Drug: Alcohol
During each arm, subjects will receive doses of alcohol, designed to raise BALs to 0.015 and 0.03 g/dl.
Drug: N-acetyl cysteine
Subjects will receive n-acetyl cysteine capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
After at least four days of placebo or n-acetylcysteine maintenance

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

William Stoops

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 15, 2017

Primary Completion (ACTUAL)

April 23, 2020

Study Completion (ACTUAL)

April 23, 2020

Study Registration Dates

First Submitted

July 7, 2017

First Submitted That Met QC Criteria

July 11, 2017

First Posted (ACTUAL)

July 13, 2017

Study Record Updates

Last Update Posted (ACTUAL)

January 26, 2021

Last Update Submitted That Met QC Criteria

January 5, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BED IN 34
  • R21AA026129 (NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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