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Summary

for people ages 18–65 (full criteria)
at San Francisco, California
study started
estimated completion:

Description

Summary

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

Details

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.

Keywords

Traumatic Brain Injury (TBI) Hazardous and Harmful Alcohol Use TBI Veterans co-occurring disorders pharmacotherapy Brain Injuries Brain Injuries, Traumatic Alcohol Drinking Ethanol Acetylcysteine N-monoacetylcystine

Eligibility

You can join if…

Open to people ages 18–65

  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.

You CAN'T join if...

  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

Location

  • San Francisco VA Medical Center accepting new patients
    San Francisco, California, 94121, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT02791945
Phase
Phase 2
Study Type
Interventional
Last Updated
October 25, 2017
I’m interested in this study!