Clinical trial NCT02791945: N-acetylcysteine Treatment of Alcohol Use Disorder In Veterans With TBI
Official title: N-acetylcysteine Treatment of Alcohol Use Disorder In Veterans With TBI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Traumatic Brain Injury (TBI)
Hazardous and Harmful Alcohol Use
Keywords: TBI
hazardous and harmful alcohol use
Veterans
co-occurring disorders
pharmacotherapy
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
name: Northern California Institute of Research and Education
name: San Francisco Veterans Affairs Medical Center
name: Institute for Translational Neuroscience
First posted: 2016-06-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 at hazardous or harmful levels.

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

Primary outcomes:
measure: Change in Percent of Heavy Drinking Days Per Week as Assessed by the Timeline Followback (TFLB)
timeFrame: Baseline to Week 8
measure: Change in TBI Symptoms as Assessed by the Neurobehavioral Symptom Inventory (NSI)
timeFrame: Baseline to Week 8
Secondary outcomes:
Other outcomes:
measure: Change in Number of Standard Drinks Per Week as Assessed by the Timeline Followback (TLFB)
timeFrame: Baseline to Week 8
Locations:
city: San Francisco
country: United States
facility: San Francisco VA Medical Center
state: California
Study officials:
affiliation: Unviersity of California, San Francisco
name: Steven L. Batki, MD
role: PRINCIPAL_INVESTIGATOR
References: