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

University of California San Francisco (UCSF)

Status and phase: Completed; Phase 2

Conditions: Hazardous and Harmful Alcohol Use; Traumatic Brain Injury (TBI)

Treatments: Drug: Placebo; Drug: N-acetylcysteine; Behavioral: Medical Management Counseling

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02791945

9236sc

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

N-acetylcysteine

Experimental group

Description:

N-acetylcysteine capsules daily - up to 3200 mg

Treatment:

Drug: N-acetylcysteine

Behavioral: Medical Management Counseling

Placebo

Placebo Comparator group

Description:

Placebo capsules daily - up to 3200 mg

Treatment:

Drug: Placebo

Behavioral: Medical Management Counseling