Phase 2
N=30
N-acetylcysteine Treatment of Alcohol Use Disorder In Veterans With TBI
Traumatic Brain Injury (TBI) · Hazardous and Harmful Alcohol Use
Bottom Line
View on ClinicalTrials.gov: NCT02791945 ↗Enrolled (actual)
30
Serious AEs
6.7%
Results posted
Dec 2020
Primary outcome: Primary: Change in Percent of Heavy Drinking Days Per Week as Assessed by the Timeline Followback (TFLB) — 26.2; 26.5 change in percent heavy drinking days/wk
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Medical Management Counseling (Behavioral); N-acetylcysteine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- May 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Percent of Heavy Drinking Days Per Week as Assessed by the Timeline Followback (TFLB) |
26.2; 26.5 | — |
| PRIMARY Change in TBI Symptoms as Assessed by the Neurobehavioral Symptom Inventory (NSI) |
11.44; 10 | — |
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
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02791945). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.