Early Phase 1
N=14
Influence of n-Acetylcysteine Maintenance on Alcohol Effects
Alcohol Use Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03216954 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Number of Alcohol Drinks Chosen — 3.1; 2.8; 3.8 Number of Alcohol Drinks Chosen
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Alcohol (Drug); Placebos (Drug); N-acetyl cysteine (Drug)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- William Stoops
- Primary completion
- Apr 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Alcohol Drinks Chosen |
3.1; 2.8; 3.8 | — |
Summary
This study will evaluate the behavioral effects of alcohol during placebo and n-acetylcysteine maintenance using sophisticated human laboratory methods.
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
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.