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

NCT ID: NCT02791945

Last Updated: 2021-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2018-05-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

N-acetylcysteine

N-acetylcysteine capsules daily - up to 3200 mg

Group Type: EXPERIMENTAL

Medical Management Counseling

Intervention Type: BEHAVIORAL

Brief alcohol counseling

N-acetylcysteine

Intervention Type: DRUG

Experimental supplement

Placebo

Placebo capsules daily - up to 3200 mg

Group Type: PLACEBO_COMPARATOR

Medical Management Counseling

Intervention Type: BEHAVIORAL

Brief alcohol counseling

Placebo

Intervention Type: DRUG

Placebo comparator

Interventions

Medical Management Counseling

Brief alcohol counseling

Intervention Type: BEHAVIORAL

N-acetylcysteine

Experimental supplement

Intervention Type: DRUG

Placebo

Placebo comparator

Intervention Type: DRUG

Other Intervention Names

NAC

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

Northern California Institute of Research and Education

OTHER

Sponsor Role: collaborator

San Francisco Veterans Affairs Medical Center

FED

Sponsor Role: collaborator

Institute for Translational Neuroscience

UNKNOWN

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven L. Batki, MD

Role: PRINCIPAL_INVESTIGATOR

Unviersity of California, San Francisco

Locations

San Francisco VA Medical Center

San Francisco, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

9236sc

Identifier Type: -

Identifier Source: org_study_id