Status:
COMPLETED
N-acetylcysteine Treatment of Alcohol Use Disorder In Veterans With TBI
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
United States Department of Defense
Northern California Institute of Research and Education
Conditions:
Traumatic Brain Injury (TBI)
Hazardous and Harmful Alcohol Use
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The goal of the project is to improve the care of Veterans with mild traumatic brain injury (mTBI) and unhealthy alcohol use.
Detailed 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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2018
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02791945
Start Date
August 1 2016
End Date
May 1 2018
Last Update
May 11 2021
Active Locations (1)
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1
San Francisco VA Medical Center
San Francisco, California, United States, 94121