Early Phase 1 Completed N=14 Randomized Triple-blind Basic Science

Influence of n-Acetylcysteine Maintenance on Alcohol Effects

Alcohol Use Disorder

Source: ClinicalTrials.gov NCT03216954 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2021

Primary outcomePrimary: Number of Alcohol Drinks Chosen — 3.1; 2.8; 3.8 Number of Alcohol Drinks Chosen

Summary

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Alcohol Drinks Chosen	3.1; 2.8; 3.8	—

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03216954). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.