Influence of n-Acetylcysteine Maintenance on Alcohol Effects

William Stoops

Status and phase: Completed; Early Phase 1

Conditions: Alcohol Use Disorder

Treatments: Drug: Alcohol; Drug: Placebos; Drug: N-acetyl cysteine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03216954

BED IN 34

R21AA026129 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Enrollment: 14 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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14 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Subjects will receive oral placebo capsules two times daily.

Treatment:

Drug: Placebos

Drug: Alcohol

Low Dose n-Acetylcysteine

Experimental group

Description:

Subjects will receive 0.6 g oral n-acetylcysteine two times daily.

Treatment:

Drug: Alcohol

Drug: N-acetyl cysteine

High Dose n-Acetylcysteine

Experimental group

Description:

Subjects will receive 1.2 g oral n-acetylcysteine two times daily.

Treatment:

Drug: Alcohol

Drug: N-acetyl cysteine