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Purpose

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

Condition

Eligibility

Eligible Ages
Between 21 Years and 55 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Criteria


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 Design

Phase
Early Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Basic Science
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University of Kentucky
Lexington, Kentucky 40507
Contact:
William W Stoops, PhD
859-257-5388
william.stoops@uky.edu

More Details

NCT ID
NCT03216954
Status
Recruiting
Sponsor
William Stoops

Study Contact

William W Stoops, PhD
8592575388
william.stoops@uky.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.