N-acetylcysteine Treatment of Alcohol Use Disorder In Veterans With TBI
Condition: Traumatic Brain Injury (TBI); Hazardous and Harmful Alcohol Use
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Alcoholism; Alcohol Drinking
Intervention: Medical Management Counseling; N-acetylcysteine; Placebo
Intervention description: Brief alcohol counseling; Experimental supplement; Placebo comparator
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: TBI; hazardous and harmful alcohol use; Veterans; co-occurring disorders; pharmacotherapy

Summary:

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

Eligibility criteria:

        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