Influence of n-Acetylcysteine Maintenance on Alcohol Effects

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

Official Title
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A Human Laboratory Study of n-Acetylcysteine for Alcohol Use Disorder

Conditions
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Alcohol Use Disorder

Intervention / Treatment
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* Drug: Alcohol
* Drug: Placebos
* Drug: N-acetyl cysteine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Subjects will receive oral placebo capsules two times daily. | Drug: Alcohol<br>* During each arm, subjects will receive doses of alcohol, designed to raise BALs to 0.015 and 0.03 g/dl.<br>Drug: Placebos<br>* Subjects will receive placebo capsules<br>|
| Experimental: Low Dose n-Acetylcysteine<br>Subjects will receive 0.6 g oral n-acetylcysteine two times daily. | Drug: Alcohol<br>* During each arm, subjects will receive doses of alcohol, designed to raise BALs to 0.015 and 0.03 g/dl.<br>Drug: N-acetyl cysteine<br>* Subjects will receive n-acetyl cysteine capsules<br>|
| Experimental: High Dose n-Acetylcysteine<br>Subjects will receive 1.2 g oral n-acetylcysteine two times daily. | Drug: Alcohol<br>* During each arm, subjects will receive doses of alcohol, designed to raise BALs to 0.015 and 0.03 g/dl.<br>Drug: N-acetyl cysteine<br>* Subjects will receive n-acetyl cysteine capsules<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Alcohol Drinks Chosen | 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. | After at least four days of placebo or n-acetylcysteine maintenance |