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

Traumatic Brain Injury (TBI) Clinical Trial

— NAC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02791945
• Other study ID #: 9236sc
• Status: Completed
• Phase: Phase 2
• Start date: August 2016
• Est. completion date: May 2018

Study information

• Verified date: April 2021
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcoholism
• Brain Injuries
• Brain Injuries, Traumatic
• Hazardous and Harmful Alcohol Use
• Traumatic Brain Injury (TBI)

Intervention

Behavioral:
• Medical Management Counseling
Brief alcohol counseling

Drug:
• N-acetylcysteine
Experimental supplement
• Placebo
Placebo comparator

Locations

Country	Name	City	State
United States	San Francisco VA Medical Center	San Francisco	California

Sponsors (5)

Lead Sponsor	Collaborator
University of California, San Francisco	Institute for Translational Neuroscience, Northern California Institute of Research and Education, San Francisco Veterans Affairs Medical Center, United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Number of Standard Drinks Per Week as Assessed by the Timeline Followback (TLFB)	The TLFB interview, using a calendar, asks participants to report the prior week's frequency of alcohol use on each day of the week.	Baseline to Week 8
Primary	Change in Percent of Heavy Drinking Days Per Week as Assessed by the Timeline Followback (TFLB)	The TLFB interview, using a calendar, asks participants to report the prior week's frequency of alcohol use on each day of the week.	Baseline to Week 8
Primary	Change in TBI Symptoms as Assessed by the Neurobehavioral Symptom Inventory (NSI)	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	Baseline to Week 8