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

Primary Purpose

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

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Medical Management Counseling

N-acetylcysteine

Placebo

About this trial

This is an interventional treatment trial for Traumatic Brain Injury (TBI) focused on measuring TBI, hazardous and harmful alcohol use, Veterans, co-occurring disorders, pharmacotherapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

San Francisco VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

N-acetylcysteine

Placebo

Arm Description

N-acetylcysteine capsules daily - up to 3200 mg

Placebo capsules daily - up to 3200 mg

Outcomes

Primary Outcome Measures

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.

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02791945

First Posted

June 1, 2016

Last Updated

April 21, 2021

Sponsor

University of California, San Francisco

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT02791945

Brief Title

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

Acronym

NAC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

August 2016 (undefined)

Primary Completion Date

May 2018 (Actual)

Study Completion Date

May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of California, San Francisco

Collaborators

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

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

TBI, hazardous and harmful alcohol use, Veterans, co-occurring disorders, pharmacotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

N-acetylcysteine

Arm Type

Experimental

Arm Description

N-acetylcysteine capsules daily - up to 3200 mg

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo capsules daily - up to 3200 mg

Intervention Type

Behavioral

Intervention Name(s)

Medical Management Counseling

Intervention Description

Brief alcohol counseling

Intervention Type

Drug

Intervention Name(s)

N-acetylcysteine

Other Intervention Name(s)

NAC

Intervention Description

Experimental supplement

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo comparator

Primary Outcome Measure Information:

Title

Change in Percent of Heavy Drinking Days Per Week as Assessed by the Timeline Followback (TFLB)

Description

The TLFB interview, using a calendar, asks participants to report the prior week's frequency of alcohol use on each day of the week.

Time Frame

Baseline to Week 8

Title

Change in TBI Symptoms as Assessed by the Neurobehavioral Symptom Inventory (NSI)

Description

Time Frame

Baseline to Week 8

Other Pre-specified Outcome Measures:

Title

Change in Number of Standard Drinks Per Week as Assessed by the Timeline Followback (TLFB)

Description

The TLFB interview, using a calendar, asks participants to report the prior week's frequency of alcohol use on each day of the week.

Time Frame

Baseline to Week 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Steven L. Batki, MD

Organizational Affiliation

Unviersity of California, San Francisco

Official's Role

Principal Investigator

Facility Information:

Facility Name

San Francisco VA Medical Center

City

San Francisco

State/Province

California

ZIP/Postal Code

94121

Country

United States

12. IPD Sharing Statement

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

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