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

Phase 2

Completed

• Conditions: Hazardous and Harmful Alcohol Use; Traumatic Brain Injury (TBI)
• Interventions: Behavioral: Medical Management Counseling; Drug: Placebo; Drug: N-acetylcysteine

• Registration Number: NCT02791945
• Lead Sponsor: University of California, San Francisco

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.

Study Timeline

• Study First Submitted: 2016-06-01
• Study First Submitted QC: 2016-06-01
• Study First Posted: 2016-06-07
• Study Start: 2016-08
• Primary Completion: 2018-05
• Study Completion: 2018-05
• Results First Submitted: 2020-06-10
• Results First Submitted QC: 2020-11-19
• Results First Posted: 2020-12-16
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-21
• Last Update Posted: 2021-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Medical Management Counseling	Placebo capsules daily - up to 3200 mg
Placebo	Placebo	Placebo capsules daily - up to 3200 mg
N-acetylcysteine	Medical Management Counseling	N-acetylcysteine capsules daily - up to 3200 mg
N-acetylcysteine	N-acetylcysteine	N-acetylcysteine capsules daily - up to 3200 mg

Primary Outcome Measures

Name	Time	Method
Change in Percent of Heavy Drinking Days Per Week as Assessed by the Timeline Followback (TFLB)	Baseline to Week 8	The TLFB interview, using a calendar, asks participants to report the prior week's frequency of alcohol use on each day of the week.
Change in TBI Symptoms as Assessed by the Neurobehavioral Symptom Inventory (NSI)	Baseline to Week 8	Participants indicate the extent to which each of the 22 symptoms has disturbed them in the previous 2 weeks on a 5-item scale (0-none to 4-severe). The NSI total score is the sum of severity ratings of the symptoms. The scores are summed to yield a total score ranging from 0 to 88, where the higher the point value, the greater (more severe) the symptoms

Trial Locations

Locations (1)

San Francisco VA Medical Center; 🇺🇸 San Francisco, California, United States