A Study of NAC for AUD

• Status: Not yet recruiting
• Trial end date: 2025-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This proposed pilot study aims to assess the effects of N-acetylcysteine (NAC) on alcohol use disorder (AUD). Despite promising preliminary research, no investigations to date have focused on NAC with alcohol use as the primary aim or on individuals specifically seeking treatment for AUD. The present proposal is an 7-week randomized, double-blind, placebo-controlled study of 3000mg of NAC in up to 50 participants (25 NAC, 25 placebo).

The primary aim of the current study is to establish feasibility, dropout rate, and estimate the standard deviation of the outcome measures in order to estimate the required sample for a fully powered clinical trial and to refine the final measures for use in the fully powered clinical trial. Additionally, this study will explore preliminary efficacy signal of NAC.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Uniformed Services University of the Health Sciences
• Treatments: Acetylcysteine; N-monoacetylcystine

Criteria

Inclusion criteria:

1. Greater than or equal to 18 years of age

2. Meets DSM-V criteria for alcohol use disorder on the SCID-5

3. MHS Healthcare Beneficiary

NOTE. While we are recruiting explicitly from the Addiction Treatment Services (ATS) patient population, we do not require that they are currently receiving treatment at ATS. For participants that are not currently in care we will provide them with resources to pursue psychotherapy while engaged in our study as outlined in the interview treatment questions and physical and mental health resource document.

Exclusion criteria:

1. Lifetime clinical diagnosis of schizophrenia or bipolar disorder

2. Currently receiving medication for the treatment of alcohol use disorder including oral or injectable naltrexone (ReVia, Vivitrol), disulfiram (Antabuse), and acamprosate (Campral).

3. Pregnancy

4. Lack of English fluency sufficient to complete study measures.

5. Trying to get pregnant in the next 4 months.

6. Hospitalized because of alcohol use in the past 12 months.

7. History of seizures or delirium tremens.

8. History of liver disease

9. Diagnosis of a neurocognitive disorder (e.g., dementia, alzheimer's, mental retardation).

10. Individuals who were never enrolled into Addiction Treatment Services