Influence of n-Acetylcysteine Maintenance on Alcohol Effects

Purpose

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

Condition

  • Alcohol Use Disorder

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

More Details

NCT ID
NCT03216954
Status
Completed
Sponsor
William Stoops