Alcohol DependenceNCT01408641
Topiramate for Alcohol Use in Posttraumatic Stress Disorder
A study testing Topiramate in people with Alcohol Dependence and Alcoholism, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
Alcohol abuse and dependence (alcohol use disorders, AUDs) and posttraumatic stress disorder (PTSD) are both prevalent in Veterans. Treating AUDs in Veterans with PTSD may be more difficult than treating AUDs in the general population. Read more about this study
- Who is it for?
- Ages 21 to 64 years, men only
- Conditions the study is for
- Alcohol Dependence, Alcoholism, Alcohol Abuse
- What is being tested?
- Topiramate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Aug 2013
- Phase
- Interventional
- 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 21 to 64 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male
- Ages 21-64
- Diagnosis of PTSD via a score of 50 or higher on the Clinician Administered PTSD Scale (CAPS)
- Alcohol abuse or dependence per diagnosis in the medical record -or- by consuming more than 35 standard drinks per week over the previous 4 weeks as measured by the Timeline Follow-Back Interview
- A desire to reduce drinking behavior
- Any Race/Ethnicity
Who cannot join
- Currently taking a carbonic anhydrase inhibitor (e.g. zonisamide, acetazolamide, dichlorphenamide)
- Currently taking or have taken in the previous 3 months: acamprosate, naltrexone, disulfiram, topiramate
- Change in benzodiazepine dose within the previous 3 months
- Change in other (non-benzodiazepine) medication dose within the last 4 weeks
- Seizure disorder documented in the medical record
- Head trauma with loss of consciousness for greater than 30 minutes -or- a diagnosis of post-concussive syndrome documented in the medical record
Show all 15Show fewer
- Suicide attempt within the previous 3 months or suicidal ideation within the previous 4 weeks
- A history of kidney stones
- A history of glaucoma
- ALT or AST liver enzymes elevated more than twice the upper limit of normal
- More than 4 unsuccessful attempts at inpatient alcohol treatment
- Medically unstable (including significant hypertension despite adequate treatment)
- A history of delirium tremens ("DTs") or alcohol withdrawal seizure
- Compulsory treatment to avoid legal consequences (e.g. imprisonment)
- Currently in a setting without access to alcohol (e.g. locked inpatient unit)
Trial locations and contacts
1 site in 1 country.
United States1 site
Baltimore VA, VA Maryland Health Care System
Baltimore, Maryland, 21201
About this study
Official title: A 14-week Randomized, Placebo-controlled Study of Topiramate for Alcohol Use Disorders in Veterans With Posttraumatic Stress Disorder
Alcohol abuse and dependence (alcohol use disorders, AUDs) and posttraumatic stress disorder (PTSD) are both prevalent in Veterans. Treating AUDs in Veterans with PTSD may be more difficult than treating AUDs in the general population. The FDA-approved medication topiramate has been shown to improve drinking outcomes in people with AUDs. Topiramate has also improved symptoms in people with PTSD. This study is designed to investigate whether topiramate will improve drinking outcomes in Veterans with PTSD.
- Conditions
- Alcohol Dependence, Alcoholism, Alcohol Abuse, Alcohol Use Disorder, PTSD, Posttraumatic Stress Disorder
- Being tested
- Topiramate, Placebo
- Keywords
- topiramate, PTSD, drinking, alcohol
- Medical subject headings
- Alcoholism, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TopiramateDrug
Also called Topamax
Topiramate titrated over 6 weeks to 400mg or highest tolerated dose.
PlaceboDrug
Placebo capsules without topiramate
| Study group | Role | What they receive |
|---|---|---|
| Topiramate | Experimental | Topiramate arm will be titrated (dose will increase slowly) over 6 weeks to 400mg or highest tolerated dose. Receives: Drug: Topiramate |
| Placebo (Sugar Pill) | Placebo comparator | Placebo arm will receive matching capsules without topiramate. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Heavy Drinking Days
The Alcohol Timeline Follow Back (TLFB) interview was conducted to establish a baseline drinking pattern over the previous 90 days and confirm the presence of an alcohol use disorder (defined as consumption of greater than 35 standard drinks per week over the previous 4 weeks). The TLFB involves asking participants to retrospectively report their drinking days using a calendar.
Measured: 14 weeks
Secondary outcomes (1)
Amount of PTSD Symptoms
The Clinician Administered PTSD Scale (CAPS) contains 30 questions relating to PTSD symptoms. Each question asks about both the frequency and the severity of each symptom. These questions are split into categories. Each criterion has several questions, and scores for each criterion are added up at the end. To meet criteria for a symptom, a patient must meet criteria in both frequency and intensity score for each item. Frequency and intensity and then combined to form a single severity score. Severity scores range from 0-4, with 0 being absent to 4 being extreme/incapacitating.
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2011 (estimated)
- Study startSep 2012
- Primary completionJul 2013
- Study completionAug 2013
Why it stopped: Principal Investigator was deployed overseas
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 Alcohol DependenceStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- US Department of Veterans Affairs
- Responsible party
- Principal investigator, MPRC, University of Maryland, Baltimore
- Investigators
- Bernard A Fischer, M.D., Principal investigator, Department of Veterans Affairs, University of Maryland School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01408641
- Sponsor's protocol ID
- HP-00047672
- Status last verified
- Mar 2022
- First submitted
- 1 Aug 2011
- Last updated
- 3 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 14-week Randomized, Placebo-controlled Study of Topiramate for Alcohol Use Disorders in Veterans With Posttraumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT01408641
- Acronym / sponsor ID
- HP-00047672
- Conditions
- Alcohol Dependence, Alcoholism, Alcohol Abuse, Alcohol Use Disorder, PTSD, Posttraumatic Stress Disorder
- Keywords
- topiramate, PTSD, drinking, alcohol
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Principal Investigator was deployed overseas
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- US Department of Veterans Affairs
- Study start
- Sep 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 3 Aug 2011 (estimated)
- Results
- Posted 24 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Alcohol abuse and dependence (alcohol use disorders, AUDs) and posttraumatic stress disorder (PTSD) are both prevalent in Veterans. Treating AUDs in Veterans with PTSD may be more difficult than treating AUDs in the general population. The FDA-approved medication topiramate has been shown to improve drinking outcomes in people with AUDs. Topiramate has also improved symptoms in people with PTSD. This study is designed to investigate whether topiramate will improve drinking outcomes in Veterans with PTSD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topiramate | Experimental | Drug: TopiramateTopiramate arm will be titrated (dose will increase slowly) over 6 weeks to 400mg or highest tolerated dose. |
| Placebo (Sugar Pill) | Placebo comparator | Drug: PlaceboPlacebo arm will receive matching capsules without topiramate. |
Who may qualify
- Ages
- 21 to 64 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male
- Ages 21-64
- Diagnosis of PTSD via a score of 50 or higher on the Clinician Administered PTSD Scale (CAPS)
- Alcohol abuse or dependence per diagnosis in the medical record -or- by consuming more than 35 standard drinks per week over the previous 4 weeks as measured by the Timeline Follow-Back Interview
- A desire to reduce drinking behavior
Key exclusion criteria (15 listed)
- Currently taking a carbonic anhydrase inhibitor (e.g. zonisamide, acetazolamide, dichlorphenamide)
- Currently taking or have taken in the previous 3 months: acamprosate, naltrexone, disulfiram, topiramate
- Change in benzodiazepine dose within the previous 3 months
- Change in other (non-benzodiazepine) medication dose within the last 4 weeks
- Seizure disorder documented in the medical record
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 |
|---|---|---|
| TopiramateAlso: TopamaxTopiramate titrated over 6 weeks to 400mg or highest tolerated dose. | Drug | Topiramate |
| PlaceboPlacebo capsules without topiramate | Drug | Placebo (Sugar Pill) |
Primary outcome
Percentage of Heavy Drinking Days
Time frame: 14 weeks
The Alcohol Timeline Follow Back (TLFB) interview was conducted to establish a baseline drinking pattern over the previous 90 days and confirm the presence of an alcohol use disorder (defined as consumption of greater than 35 standard drinks per week over the previous 4 weeks). The TLFB involves asking participants to retrospectively report their drinking days using a calendar.
1 secondary outcome
Amount of PTSD Symptoms
Time frame: 14 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
- 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.
Bernard A Fischer, M.D. principal investigator
Department of Veterans Affairs, University of Maryland School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topiramate in people with Alcohol Dependence and Alcoholism, run by University of Maryland, Baltimore 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 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: stopped early, as of the sponsor's last update on 3 Mar 2022. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 May 2018). 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?
Percentage of Heavy Drinking Days (time frame: 14 weeks). 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 3 Mar 2022.