N-acetylcysteine Treatment of Alcohol Use Disorder In Veterans With TBI (NAC)

April 21, 2021 updated by: University of California, San Francisco
The goal of the project is to improve the care of Veterans with mild traumatic brain injury (mTBI) and unhealthy alcohol use.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a pilot controlled clinical trial that aims to assess the efficacy of N-acetylcysteine (NAC) to reduce alcohol use and improve brain injury symptoms in Veterans with mTBI who consume alcohol at hazardous or harmful levels.

Study Type

Interventional

Enrollment (Actual)

30

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.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94121
        • San Francisco VA Medical Center

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male and female veterans
  2. Ages 18-65 (inclusive)
  3. A history of mTBI as defined by American Congress of Rehabilitation Medicine (ACRM), in the chronic, stable phase of recovery (>6 months from injury).
  4. Current (past month [30 days]) Hazardous or Harmful Alcohol Use: Hazardous use is drinking that meets NIAAA criteria: Current (past 30 day) weekly drinking, consisting of an average of 15 standard drinks/week for men or 8 standard drinks/week for women. Harmful use is drinking behavior that meets DSM-5 criteria mild AUD.
  5. Participants must express a desire to reduce or stop alcohol use.
  6. Female subjects that must have a negative urine pregnancy test and must be either postmenopausal one year or practicing an effective birth control method.

Exclusion Criteria:

  1. Unstable psychotic or bipolar disorders, dementia, or other psychiatric disorders judged to be unstable in the clinical judgment of the PI or study physician.
  2. Clinically significant unstable medical conditions, in the clinical judgment of the PI or study physician.
  3. Female patients who are pregnant or nursing.
  4. Concurrent participation in another alcohol treatment study, or in any research study involving medications.
  5. Requiring acute medical detoxification from alcohol based on a score of 12 or more on the Clinical Institute Withdrawal Assessment of Alcohol Scale (CIWA-AD).
  6. NAC use in the past week prior to study entry.
  7. Use of AUD treatment medications (disulfiram, naltrexone, or acamprosate) within the past week.
  8. Participants who are legally mandated to participate in an alcohol treatment program.
  9. Participants who have had a suicide attempt in the past 3 months or suicidal ideation, with intent, in the 30 days prior to enrollment.
  10. Participants who in the opinion of the investigator should not be enrolled in the study because of the precautions, warnings or contraindications outlined in the NAC package insert.
  11. Participants with known hypersensitivity to acetylcysteine

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: N-acetylcysteine
N-acetylcysteine capsules daily - up to 3200 mg
Behavioral: Medical Management Counseling
Brief alcohol counseling
Drug: N-acetylcysteine
Experimental supplement
Other Names:
  • NAC
Placebo Comparator: Placebo
Placebo capsules daily - up to 3200 mg
Drug: Placebo
Placebo comparator
Behavioral: Medical Management Counseling
Brief alcohol counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Percent of Heavy Drinking Days Per Week as Assessed by the Timeline Followback (TFLB)
Time Frame: Baseline to Week 8
The TLFB interview, using a calendar, asks participants to report the prior week's frequency of alcohol use on each day of the week.
Baseline to Week 8
Change in TBI Symptoms as Assessed by the Neurobehavioral Symptom Inventory (NSI)
Time Frame: Baseline to Week 8
Participants indicate the extent to which each of the 22 symptoms has disturbed them in the previous 2 weeks on a 5-item scale (0-none to 4-severe). The NSI total score is the sum of severity ratings of the symptoms. The scores are summed to yield a total score ranging from 0 to 88, where the higher the point value, the greater (more severe) the symptoms
Baseline to Week 8

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Number of Standard Drinks Per Week as Assessed by the Timeline Followback (TLFB)
Time Frame: Baseline to Week 8
The TLFB interview, using a calendar, asks participants to report the prior week's frequency of alcohol use on each day of the week.
Baseline to Week 8

Collaborators and Investigators

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

Sponsor

University of California, San Francisco

Collaborators

United States Department of Defense
Northern California Institute of Research and Education
San Francisco Veterans Affairs Medical Center
Institute for Translational Neuroscience

Investigators

  • Principal Investigator: Steven L. Batki, MD, Unviersity of California, San Francisco

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

August 1, 2016

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

June 1, 2016

First Submitted That Met QC Criteria

June 1, 2016

First Posted (Estimate)

June 7, 2016

Study Record Updates

Last Update Posted (Actual)

May 11, 2021

Last Update Submitted That Met QC Criteria

April 21, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9236sc

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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