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

Completed · Phase 2 · Has a placebo group

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

In brief

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

Key facts

Study ID

NCT02791945

Run by

University of California, San Francisco

People needed

30

Starts

2016-08-01

Expected to finish

2018-05-01

Last updated by the study team

2021-05-11

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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