Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02791945
Recruitment Status : Completed
First Posted : June 7, 2016
Last Update Posted : October 16, 2018
Sponsor:
Collaborators:
United States Department of Defense
Northern California Institute of Research and Education
San Francisco Veterans Affairs Medical Center
Institute for Translational Neuroscience
Information provided by (Responsible Party):
University of California, San Francisco

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

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury (TBI) Hazardous and Harmful Alcohol Use Behavioral: Medical Management Counseling Drug: N-acetylcysteine Drug: Placebo Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: N-acetylcysteine Treatment of Alcohol Use Disorder In Veterans With TBI
Study Start Date : August 2016
Actual Primary Completion Date : May 2018
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arm Intervention/treatment
Experimental: N-acetylcysteine
N-acetylcysteine capsules daily - up to 3200 mg
Behavioral: Medical Management Counseling
Brief alcohol counseling

Drug: N-acetylcysteine
Experimental supplement
Other Name: NAC

Placebo Comparator: Placebo
Placebo capsules daily - up to 3200 mg
Behavioral: Medical Management Counseling
Brief alcohol counseling

Drug: Placebo
Placebo comparator




Primary Outcome Measures :
  1. Change in the number of heavy drinking days as assessed by the Timeline Followback (TFLB) [ Time Frame: Baseline to Week 8 ]
    Using a calendar, participants provide retrospective estimates of daily drinking over a specified period.

  2. Change in TBI symptoms as assessed by the Neurobehavioral Symptom Inventory (NSI) [ Time Frame: Baseline to Week 8 ]

    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.



Other Outcome Measures:
  1. Change in alcohol use as assessed by the Timeline Followback (TLFB) [ Time Frame: Baseline to Week 8 ]
    Using a calendar, participants provide retrospective estimates of daily drinking over a specified period.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02791945


Locations
Layout table for location information
United States, California
San Francisco VA Medical Center
San Francisco, California, United States, 94121
Sponsors and Collaborators
University of California, San Francisco
United States Department of Defense
Northern California Institute of Research and Education
San Francisco Veterans Affairs Medical Center
Institute for Translational Neuroscience
Investigators
Layout table for investigator information
Principal Investigator: Steven L. Batki, MD Unviersity of California, San Francisco

Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02791945     History of Changes
Other Study ID Numbers: 9236sc
First Posted: June 7, 2016    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Keywords provided by University of California, San Francisco:
TBI
hazardous and harmful alcohol use
Veterans
co-occurring disorders
pharmacotherapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Acetylcysteine
N-monoacetylcystine
Brain Injuries
Brain Injuries, Traumatic
Alcoholism
Alcohol Drinking
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Antiviral Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Antidotes