A Study of NAC for AUD (NAC)

July 18, 2023 updated by: Uniformed Services University of the Health Sciences

A Pilot Study of N-acetylcysteine for Alcohol Use Disorder

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Alcohol abuse is responsible for 1 in 10 deaths among working age adults in the U.S. and costs ~$249 billion annually. Currently approved medications for alcohol use disorder (AUD) exert only small to medium effects on drinking, with estimates indicating 12 to 20 drinkers need to be treated for one of them to benefit from the two leading medications, acamprosate and naltrexone. Thus, many patients do not benefit from current pharmacotherapies for AUD.

N-acetylcysteine (NAC) is one promising pharmacotherapy that is well-tolerated, safe, and exhibits preliminary evidence across a number of psychiatric and neurological disorders. NAC is available over the counter, has been used all over the world for a variety of conditions, most notably for its 1985 FDA approved use as an antidote for acetaminophen overdose.

The NAC dosage was selected as most prior studies in addiction have used 2400-3000mg and even studies up to 3600mg have found it was well-tolerated. Many studies using doses in this range achieved clinically significant improvements, including a study of NAC for smoking cessation which used 3000mg. 7 weeks was selected rather than 12 weeks or longer duration because this within the range of prior clinical trials of NAC (most are 8-12 weeks) and is fitting for the goals of this pilot trial seeking to establish feasibility and sample size for a larger clinical trial. It is beyond the primary aims of this study and the resources of the team to seek longer term outcomes (e.g., drinking at 6 months; https://www.fda.gov/media/91222/download).

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: N-acetylcysteine
25 participants randomly selected to receive 1500 milligrams of oral n-acetylcysteine twice daily for 7 weeks.
Drug: N-acetylcysteine
N-acetylcysteine is an FDA approved medication that is used to treat acetaminophen overdose.
Placebo Comparator: Placebo
25 participants randomly selected to receive placebo twice daily for 7 weeks.
Drug: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in total drinking days
Time Frame: 7 weeks
Change in total drinking days will be assessed with the Timeline Follow Back alcohol use assessment
7 weeks
Change in drinks per drinking day
Time Frame: 7 weeks
Change in drinks per drinking day will be assessed with the Timeline Follow Back alcohol use assessment
7 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in alcohol cue-reactivity
Time Frame: 7 weeks
Change in alcohol cue-reactivity will be assessed with a task in which participants are exposed to stimuli associated with alcohol
7 weeks
Change in alcohol demand
Time Frame: 7 weeks
Change in alcohol demand will be assessed with the alcohol purchase task
7 weeks
Change in alcohol craving
Time Frame: 7 weeks
Change in alcohol craving will be assessed with the Penn Alcohol Craving Scale, a 5-item measure of craving for alcohol over the past week. Scores range from 0 to 30, higher scores indicate more alcohol craving.
7 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in response inhibition
Time Frame: 7 weeks
Change in response inhibition will be assessed with the Stop Signal Task.
7 weeks
Change in working memory
Time Frame: 7 weeks
Change in working memory will be assessed with the N-back task (2 back and 3 back)
7 weeks
Change in executive functioning
Time Frame: 7 weeks
Change in executive functioning will be assessed with the Trail Making Task
7 weeks
Change in depression symptoms
Time Frame: 7 weeks
Change in depression symptoms will be assessed with the Montgomery-Åsberg Depression Rating Scale (MADRS), a 10-item questionnaire assessing depression symptoms. Scores range from 0-60, higher scores indicate more depression symptoms
7 weeks
Change in anxiety symptoms
Time Frame: 7 weeks
Change in anxiety symptoms will be assessed with the Generalized Anxiety Disorder Screener (GAD-7), a 7-item self-report measure assessing symptoms of generalized anxiety. Scores range from 0-21, higher scores indicate more anxiety symptoms.
7 weeks
Change in anxiety symptoms
Time Frame: 7 weeks
Change in anxiety symptoms will be assessed with the Social Interaction Anxiety Scale (SIAS-6), a 6-item measure of social interaction anxiety. Scores range from 0-24 where higher scores indicate higher anxiety.
7 weeks
Change in anxiety symptoms
Time Frame: 7 weeks
Change in anxiety symptoms will be assessed with the Social Phobia Scale (SPS-6), a 6-item measure of social phobia anxiety. Scores range from 0-24 where higher scores indicate higher anxiety.
7 weeks
Change in total marijuana use days
Time Frame: 7 weeks
Change in total marijuana use days will be assessed with the Timeline Follow Back marijuana use assessment in the subset of individuals who use marijuana.
7 weeks
Change in total cigarette use days
Time Frame: 7 weeks
Change in total cigarette use days will be assessed with the Timeline Follow Back cigarette use assessment in the subset of individuals who use cigarettes.
7 weeks
Change in cigarettes per day
Time Frame: 7 weeks
Change in cigarettes per day will be assessed with the Timeline Follow Back cigarette use assessment in the subset of individuals who use cigarettes.
7 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uniformed Services University of the Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2023

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

June 17, 2021

First Submitted That Met QC Criteria

July 13, 2021

First Posted (Actual)

July 16, 2021

Study Record Updates

Last Update Posted (Actual)

July 21, 2023

Last Update Submitted That Met QC Criteria

July 18, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0000 (Centre for care Science, KI, Norrbacka Eugeniastiftelsen)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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