Traumatic Brain Injury (TBI)Phase 4VATNCT01750268
Topiramate Treatment of Hazardous and Harmful Alcohol Use in Veterans With TBI
A Phase 4 study testing Medical Management Counseling and Topiramate 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 proposed project is to improve the treatment of veterans with co-occurring traumatic brain injury (TBI) and hazardous or harmful alcohol use. The PI and coinvestigators will conduct a pilot controlled clinical trial of topiramate for the treatment of these co-occurring disorders. 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 Topiramate
- 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
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Oct 2015
- Phase
- Phase 4
- 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 to 65 (inclusive).
- TBI: a history of mild traumatic brain injury, as defined by American Congress of Rehabilitation Medicine (ACRM) and VA, in the chronic, stable phase of recovery (>6 months from injury). The ACRM defines mild TBI as a traumatically-induced physiological disruption of brain function as demonstrated by at least one of the following:
- 3.a. loss of consciousness of up to 30 minutes;
- 3.b. any loss of memory for events immediately before or after the event;
- 3.c. any alteration in mental state at the time of the event, for example feeling dazed, disoriented, or confused; and
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- 3.d. a focal neurological deficit or deficits that may or may not have been transient, for example loss of coordination, speech difficulties, or double vision. ACRM's definition further specifies that a person may be designated as having a mild TBI only if the severity of the injury does not include a loss of consciousness that lasted longer than 30 minutes, and post-traumatic amnesia lasting longer than 24 hours.
- Rationale:
- This is the most common description of patients currently served by our VA facilities.
- Studies at this stable phase will facilitate detection of otherwise subtle changes as findings are less likely to be confounded by 'spontaneous' recovery.
- 4. Current (past month) hazardous alcohol use or harmful alcohol use.
- 4.a. Hazardous use is drinking that must meet criteria for "at-risk" or "heavy" drinking by National Institute on Alcohol Abuse and Alcoholism (NIAAA) criteria: Subjects must report current (past 30 day) "at-risk" or "heavy" drinking on an average weekly basis, consisting of an average of 15 or more standard drinks per week for men and 8 or more standard drinks per week for women during the 30 days prior to Screening Visit 1 as measured by the Alcohol Timeline Followback (TLFB) method.
- 4.b. Harmful use is drinking behavior that meets Diagnostic and Statistical Manual (DSM)-IV diagnostic criteria for an Alcohol Use Disorder (Alcohol Dependence or Alcohol Abuse).
- 5. Subjects must express a desire to reduce or stop alcohol use.
- 6. Female subjects must have a negative urine pregnancy test and must be either postmenopausal for at least 1 year or practicing an effective method of birth control (e.g., surgically sterile, spermicide with barrier, male partner sterilization; or absent and agrees to continue abstinence or to use an acceptable method of contraception, as listed above, should sexual activity commence).
- 7. Subjects must have a Breath Alcohol Concentration (BAC) of less than 0.02% when signing the informed consent form.
Who cannot join
- Psychotic disorders, bipolar disorders, dementia, or other psychiatric disorders judged to be unstable.
- Subjects known to have clinically significant unstable medical conditions, including but not limited to: Clinically significant renal disease and/or impaired renal function as defined by clinically significant elevation of blood urea nitrogen (BUN) or creatinine or an estimated creatinine clearance of < 60 mL/min; AST and/or ALT > 5 times the upper limit of the normal range and/or a serum bilirubin > 2 times the upper limit of normal.
- History of glaucoma.
- History of kidney stones.
- Concurrent participation in another alcohol treatment study or any study involving medications.
- Female patients who are pregnant or lactating.
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- Topiramate use in the past week prior to study entry.
- Use of medications for alcohol dependence (disulfiram, naltrexone, or acamprosate) within the past week.
- Needing acute medical detoxification from alcohol based on a score of 12 or more on the Clinical Institute Withdrawal Assessment of Alcohol Scale (CIWA-AD).
- Subjects who are legally mandated to participate in an alcohol treatment program.
- Subjects who have had a suicide attempt in the past 6 months or suicidal ideation, with intent, in the 30 days prior to enrollment.
- Subjects who have previously been treated with topiramate for any reason and discontinued treatment due to an adverse event or due to a hypersensitivity reaction to topiramate.
- Subjects with seizure disorders.
- Subjects currently being treated with another anticonvulsant.
- Subjects who in the opinion of the investigator should not be enrolled in the study because of the precautions, warnings or contraindications outlined in the topiramate package insert.
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 proposed project is to improve the treatment of veterans with co-occurring traumatic brain injury (TBI) and hazardous or harmful alcohol use. The PI and coinvestigators will conduct a pilot controlled clinical trial of topiramate for the treatment of these co-occurring disorders.
- Being tested
- Medical Management Counseling, Topiramate, 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 and medication counseling
TopiramateDrug
Also called Topamax
Experimental medication
PlaceboDrug
Placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| Topiramate | Experimental | Topiramate capsules daily - up to 300 mg Receives: Behavioral: Medical Management Counseling; Drug: Topiramate |
| Placebo | Placebo comparator | Placebo capsules daily - up 300 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 the Number of Drinking Days Per Week as Assessed by the Timeline Followback (TLFB)
Using a calendar, participants provide retrospective estimates of daily drinking over a specified period.
Measured: Baseline to Week 12
Secondary outcomes (1)
Change in TBI Symptom Severity 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 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionOct 2015
- Study completionOct 2015
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 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
- Responsible party
- Sponsor
- Investigators
- Steven L. Batki, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01750268
- Sponsor's protocol ID
- W81XWH-11-2-0145
- Acronym
- VAT
- Status last verified
- Sep 2020
- First submitted
- 28 Nov 2012
- Last updated
- 14 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Pennington DL, Bielenberg J, Lasher B, Herbst E, Abrams G, Novakovic-Agopian T, Batki SL. A randomized pilot trial of topiramate for alcohol use disorder in veterans with traumatic brain injury: Effects on alcohol use, cognition, and post-concussive symptoms. Drug Alcohol Depend. 2020 Sep 1;214:108149. doi: 10.1016/j.drugalcdep.2020.108149. Epub 2020 Jul 2.
PubMed 32712569
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topiramate Treatment of Hazardous and Harmful Alcohol Use in Veterans With TBI
- ClinicalTrials.gov ID
- NCT01750268
- Acronym / sponsor ID
- VAT / W81XWH-11-2-0145
- Keywords
- TBI, hazardous and harmful alcohol use, veterans, co-occurring disorders, pharmacotherapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 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
- Study start
- Nov 2012
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 17 Dec 2012 (estimated)
- Results
- Posted 14 Oct 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 proposed project is to improve the treatment of veterans with co-occurring traumatic brain injury (TBI) and hazardous or harmful alcohol use. The PI and coinvestigators will conduct a pilot controlled clinical trial of topiramate for the treatment of these co-occurring disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topiramate | Experimental | Behavioral: Medical Management Counseling, Drug: TopiramateTopiramate capsules daily - up to 300 mg |
| Placebo | Placebo comparator | Behavioral: Medical Management Counseling, Drug: PlaceboPlacebo capsules daily - up 300 mg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Male and female veterans.
- Ages 18 to 65 (inclusive).
- TBI: a history of mild traumatic brain injury, as defined by American Congress of Rehabilitation Medicine (ACRM) and VA, in the chronic, stable phase of recovery (>6 months from injury). The ACRM defines mild TBI as a traumatically-induced physiological disruption of brain function as demonstrated by at least one of the following:
- 3.a. loss of consciousness of up to 30 minutes;
- 3.b. any loss of memory for events immediately before or after the event;
Key exclusion criteria (15 listed)
- Psychotic disorders, bipolar disorders, dementia, or other psychiatric disorders judged to be unstable.
- Subjects known to have clinically significant unstable medical conditions, including but not limited to: Clinically significant renal disease and/or impaired renal function as defined by clinically significant elevation of blood urea nitrogen (BUN) or creatinine or an estimated creatinine clearance of < 60 mL/min; AST and/or ALT > 5 times the upper limit of the normal range and/or a serum bilirubin > 2 times the upper limit of normal.
- History of glaucoma.
- History of kidney stones.
- Concurrent participation in another alcohol treatment study or any study involving medications.
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 and medication counseling | Behavioural | Placebo, Topiramate |
| TopiramateAlso: TopamaxExperimental medication | Drug | Topiramate |
| PlaceboPlacebo comparator | Drug | Placebo |
Primary outcome
Change in the Number of Drinking Days Per Week as Assessed by the Timeline Followback (TLFB)
Time frame: Baseline to Week 12
Using a calendar, participants provide retrospective estimates of daily drinking over a specified period.
1 secondary outcome
Change in TBI Symptom Severity as Assessed by the Neurobehavioral Symptom Inventory (NSI)
Time frame: Baseline to Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 32712569Pennington DL, Bielenberg J, Lasher B, Herbst E, Abrams G, Novakovic-Agopian T, Batki SL. A randomized pilot trial of topiramate for alcohol use disorder in veterans with traumatic brain injury: Effects on alcohol use, cognition, and post-concussive symptoms. Drug Alcohol Depend. 2020 Sep 1;214:108149. doi: 10.1016/j.drugalcdep.2020.108149. Epub 2020 Jul 2.
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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
University 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 4 study testing Medical Management Counseling and Topiramate 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 16 inclusion and 15 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 14 Oct 2020. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 14 Oct 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 the Number of Drinking Days Per Week as Assessed by the Timeline Followback (TLFB) (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01750268, which also lists 1 linked publication.
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 14 Oct 2020.