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

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

Detailed Description
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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.

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

Conditions
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Traumatic Brain Injury (TBI), Hazardous and Harmful Alcohol Use

Intervention / Treatment
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* Behavioral: Medical Management Counseling
* Drug: N-acetylcysteine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: N-acetylcysteine<br>N-acetylcysteine capsules daily - up to 3200 mg | Behavioral: Medical Management Counseling<br>* Brief alcohol counseling<br>Drug: N-acetylcysteine<br>* Experimental supplement<br>* Other names: NAC;|
| Placebo Comparator: Placebo<br>Placebo capsules daily - up to 3200 mg | Behavioral: Medical Management Counseling<br>* Brief alcohol counseling<br>Drug: Placebo<br>* Placebo comparator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TBI, hazardous and harmful alcohol use, Veterans, co-occurring disorders, pharmacotherapy