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

NCT02791945 | Completed Phase 2 Results DMC

• 1 other identifier: 9236sc
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

Other Outcomes (1)

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

  Baseline to Week 8

Study Arms (2)

N-acetylcysteine

EXPERIMENTAL

N-acetylcysteine capsules daily - up to 3200 mg

Behavioral: Medical Management Counseling; Drug: N-acetylcysteine

Placebo

PLACEBO COMPARATOR

Placebo capsules daily - up to 3200 mg

Behavioral: Medical Management Counseling; Drug: Placebo

Interventions

Medical Management Counseling BEHAVIORAL

Brief alcohol counseling

N-acetylcysteine; Placebo

N-acetylcysteine DRUG

Experimental supplement

Also known as: NAC

N-acetylcysteine

Placebo DRUG

Placebo comparator

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

San Francisco VA Medical Center

San Francisco, California, 94121, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. Steven L. Batki, MD
• Organization: University of California, San Francisco/San Francisco VA Healthcare System

steven.batki@ucsf.edu

415-221-4810

Study Officials

• Steven L. Batki, MD

  Unviersity of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2016
• First Posted: June 7, 2016
• Study Start: August 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: May 11, 2021
• Results First Posted: December 16, 2020

Record last verified: 2021-04

Locations

US (1)