Traumatic Brain Injury (TBI)Phase 2NACNCT02791945
N-acetylcysteine Treatment of Alcohol Use Disorder In Veterans With TBI
A Phase 2 study testing Medical Management Counseling and N-acetylcysteine in people with Traumatic Brain Injury (TBI) and Hazardous and Harmful Alcohol Use, run by University of California, San Francisco at 1 site in United States.
Trial summary
The goal of the project is to improve the care of Veterans with mild traumatic brain injury (mTBI) and unhealthy alcohol use. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Traumatic Brain Injury (TBI), Hazardous and Harmful Alcohol Use
- What is being tested?
- Medical Management Counseling and N-acetylcysteine
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to May 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco VA Medical Center
San Francisco, California, 94121
About this study
The goal of the project is to improve the care of Veterans with mild traumatic brain injury (mTBI) and unhealthy alcohol use.
Read the 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.
- Being tested
- Medical Management Counseling, N-acetylcysteine, Placebo
- Keywords
- TBI, hazardous and harmful alcohol use, Veterans, co-occurring disorders, pharmacotherapy
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical Management CounselingBehavioural
Brief alcohol counseling
N-acetylcysteineDrug
Also called NAC
Experimental supplement
PlaceboDrug
Placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| N-acetylcysteine | Experimental | N-acetylcysteine capsules daily - up to 3200 mg Receives: Behavioral: Medical Management Counseling; Drug: N-acetylcysteine |
| Placebo | Placebo comparator | Placebo capsules daily - up to 3200 mg Receives: Behavioral: Medical Management Counseling; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Baseline to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2016 (estimated)
- Study startAug 2016
- Primary completionMay 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Traumatic Brain Injury (TBI)Studies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, Northern California Institute of Research and Education, San Francisco Veterans Affairs Medical Center, Institute for Translational Neuroscience
- Responsible party
- Sponsor
- Investigators
- Steven L. Batki, MD, Principal investigator, Unviersity of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02791945
- Sponsor's protocol ID
- 9236sc
- Acronym
- NAC
- Status last verified
- Apr 2021
- First submitted
- 1 Jun 2016
- Last updated
- 11 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- N-acetylcysteine Treatment of Alcohol Use Disorder In Veterans With TBI
- ClinicalTrials.gov ID
- NCT02791945
- Acronym / sponsor ID
- NAC / 9236sc
- Keywords
- TBI, hazardous and harmful alcohol use, Veterans, co-occurring disorders, pharmacotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- United States Department of Defense, Northern California Institute of Research and Education, San Francisco Veterans Affairs Medical Center, Institute for Translational Neuroscience
- Study start
- Aug 2016
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 7 Jun 2016 (estimated)
- Results
- Posted 16 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| N-acetylcysteine | Experimental | Behavioral: Medical Management Counseling, Drug: N-acetylcysteineN-acetylcysteine capsules daily - up to 3200 mg |
| Placebo | Placebo comparator | Behavioral: Medical Management Counseling, Drug: PlaceboPlacebo capsules daily - up to 3200 mg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical Management CounselingBrief alcohol counseling | Behavioural | N-acetylcysteine, Placebo |
| N-acetylcysteineAlso: NACExperimental supplement | Drug | N-acetylcysteine |
| PlaceboPlacebo comparator | Drug | Placebo |
Primary outcome
Change in Percent of Heavy Drinking Days Per Week as Assessed by the Timeline Followback (TFLB)
Time frame: Baseline to Week 8
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)
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. 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven L. Batki, MD principal investigator
Unviersity of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Medical Management Counseling and N-acetylcysteine in people with Traumatic Brain Injury (TBI) and Hazardous and Harmful Alcohol Use, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Percent of Heavy Drinking Days Per Week as Assessed by the Timeline Followback (TFLB) (time frame: Baseline to Week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2021.