A Human Laboratory Study of n-Acetylcysteine for Alcohol Use Disorder
Overview
- Phase
- Early Phase 1
- Intervention
- Alcohol
- Conditions
- Alcohol Use Disorder
- Sponsor
- William Stoops
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Number of Alcohol Drinks Chosen
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
This study will evaluate the behavioral effects of alcohol during placebo and n-acetylcysteine maintenance using sophisticated human laboratory methods.
Investigators
William Stoops
Professor
University of Kentucky
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
Exclusion Criteria
- Not provided
Arms & Interventions
Placebo
Subjects will receive oral placebo capsules two times daily.
Intervention: Alcohol
Placebo
Subjects will receive oral placebo capsules two times daily.
Intervention: Placebos
Low Dose n-Acetylcysteine
Subjects will receive 0.6 g oral n-acetylcysteine two times daily.
Intervention: Alcohol
Low Dose n-Acetylcysteine
Subjects will receive 0.6 g oral n-acetylcysteine two times daily.
Intervention: N-acetyl cysteine
High Dose n-Acetylcysteine
Subjects will receive 1.2 g oral n-acetylcysteine two times daily.
Intervention: Alcohol
High Dose n-Acetylcysteine
Subjects will receive 1.2 g oral n-acetylcysteine two times daily.
Intervention: N-acetyl cysteine
Outcomes
Primary Outcomes
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.