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Completed

NCT Number: NCT02791945

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

The goal of the project is to improve the care of Veterans with mild traumatic brain injury (mTBI) and unhealthy alcohol use.

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Key information

Conditions

Traumatic Brain Injury (TBI) Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Hazardous and Harmful Alcohol Use Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

San Francisco VA Medical Center

San Francisco, California, 94121, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female veterans
  • Ages 18-65 (inclusive)
  • A history of mTBI as defined by American Congress of Rehabilitation Medicine (ACRM), in the chronic, stable phase of recovery (>6 months from injury).
  • 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.
  • Participants must express a desire to reduce or stop alcohol use.
  • 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

  • Unstable psychotic or bipolar disorders, dementia, or other psychiatric disorders judged to be unstable in the clinical judgment of the PI or study physician.
  • Clinically significant unstable medical conditions, in the clinical judgment of the PI or study physician.
  • Female patients who are pregnant or nursing.
  • Concurrent participation in another alcohol treatment study, or in any research study involving medications.
  • 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).
  • NAC use in the past week prior to study entry.
  • Use of AUD treatment medications (disulfiram, naltrexone, or acamprosate) within the past week.
  • Participants who are legally mandated to participate in an alcohol treatment program.
  • Participants who have had a suicide attempt in the past 3 months or suicidal ideation, with intent, in the 30 days prior to enrollment.
  • 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.
  • Participants with known hypersensitivity to acetylcysteine

Treatment and study plan

Medical Management Counseling

Behavioral

Brief alcohol counseling

N-acetylcysteine

Drug

Experimental supplement

Other names: NAC

Placebo

Drug

Placebo comparator

Primary outcomes

  1. 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.

  2. 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

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

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

Registry information

Acronym: NAC

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 7, 2016
Registry last updated
May 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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