Alcohol DependencePhase 4TAP2NCT01749215
A Controlled Trial of Topiramate Treatment for Alcohol Dependence in Veterans With PTSD
A Phase 4 study testing Topiramate and Medical Management in people with Alcohol Dependence and Posttraumatic Stress Disorder (PTSD), run by University of California, San Francisco at 1 site in United States.
Trial summary
The goal of this project is to improve the treatment of veterans with co-occurring alcohol dependence and posttraumatic stress disorder (PTSD). The PI and co-investigators will conduct a 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
- Alcohol Dependence, Posttraumatic Stress Disorder (PTSD)
- What is being tested?
- Topiramate and Medical Management
- 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
- 151 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Jul 2019
- 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
- Ages18 to 69 (inclusive)
- Current DSM-IV diagnosis of PTSD
- Current (past month) DSM-IV diagnosis of an Alcohol Dependence
- Level of drinking must meet criteria for "at-risk " or "heavy" drinking by NIAAA threshold (NIAAA 2007): at least 15 standard drinks per week on average over the 4 weeks prior to study entry for men and at least 8 standard drinks per week on average for women.
- Subjects must express a desire to reduce alcohol consumption with the possible long-term goal of abstinence.
- Female subjects must have a negative urine pregnancy test and must be either postmenopausal for at least one year, or practicing an effective method of birth control (e.g., surgically sterile, spermicide with barrier, male partner sterilization; or abstinent and agrees to continue abstinence or to use an acceptable method of contraception, as listed above, should sexual activity commence)
- Subjects must have a Breath Alcohol Concentration (BAC) of < 0.02% when signing informed consent.
Who cannot join
- Psychotic disorders, bipolar disorder, 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 an increased serum bilirubin >2 times the upper limit of normal.
- Seizure disorders
- History of glaucoma.
Show all 18Show fewer
- History of kidney stones.
- Concurrent participation in another treatment study.
- Female patients who are pregnant or lactating.
- Current Topiramate use or use within the past 4 weeks.
- Current medications for alcohol dependence (disulfiram, naltrexone, or acamprosate) or use in 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 in the 90 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 that require anticonvulsant medications
- 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 this project is to improve the treatment of veterans with co-occurring alcohol dependence and posttraumatic stress disorder (PTSD). The PI and co-investigators will conduct a controlled clinical trial of topiramate for the treatment of these co-occurring disorders.
Read the detailed description
This project consists of a controlled clinical trial of topiramate treatment to reduce alcohol use and PTSD symptoms in veterans with these co-occurring disorders.
This is a prospective randomized double-blind controlled parallel groups clinical trial of topiramate or or placebo up to 300 mg per day, combined with weekly alcohol counseling, over a 12-week treatment period with a week 16 follow-up. The study population consists of 150 male and female veterans between the ages of 18-69 who have concurrent diagnoses of alcohol use disorder and PTSD. Subjects meet with research staff weekly to receive study medication, manualized alcohol counseling, and research assessments. The primary treatment outcome is the percent of days of drinking; the secondary outcome is PTSD symptom severity. Exploratory measures include assessments of impulsivity and decision-making.
- Being tested
- Topiramate, placebo, Medical Management
- Keywords
- pharmacotherapy, alcohol dependence, Veterans
- 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
Experimental study drug
placeboDrug
Placebo comparator
Medical ManagementBehavioural
Brief alcohol counseling
| Study group | Role | What they receive |
|---|---|---|
| Topiramate | Experimental | Topiramate capsules daily - up to 300 mg Receives: Drug: Topiramate; Behavioral: Medical Management |
| Placebo | Placebo comparator | Placebo capsules daily - up to 300 mg Receives: Drug: placebo; Behavioral: Medical Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Percentage of Heavy Drinking Days Over the 12 Weeks of Study Treatment as Assessed by the Timeline Followback (TFLB)
Timeline Followback (TLFB) data was recorded using a calendar, with participants providing retrospective reports of daily drinking over the past week(s). The percent of heavy drinking days per week was calculated from the calendar data. The change in percentage of heavy drinking days was calculated by subtracting Week 0 (baseline) data from Week 12. Negative scores indicate improvement.
Measured: Baseline to Week 12
Secondary outcomes (4)
Change in PTSD Symptom Severity as Assessed by the PTSD Checklist (PCL)
The PCL is a 17-item self-report measure reflecting DSM-IV symptoms of PTSD. A total symptom severity score (range = 17-85) can be obtained by summing the scores from each of the 17 items that have response options ranging from 1 "Not at all" to 5 "Extremely". It was calculated by subtracting the data collected at Week 0 (baseline) from data collected at Week 12. Negative scores indicate improvement.
Measured: Baseline to Week 12
Change in Impulsivity as Assessed by Delay Discounting (DD)
DD measures impulsivity by evaluating discount rates for delayed rewards. On a computer screen, the participant is shown hypothetical dollar amounts that could be received immediately, while a hypothetical $100 reward is displayed continuously. The "delay duration" is the waiting period for the $100 delayed reward. The computer randomly presents each immediate reward dollar amount, one at a time and participants are asked to choose between each immediate reward or the delayed $100. The same procedure will be repeated for each of the delay periods. Delay discounting quantifies the devaluation of rewards over time, which allows for an index of overall discounting rate (k). Higher k values indicate greater discounting and therefore greater impulsivity. DD score change was measured by subtracting Week 0 (baseline) scores from Week 12 scores, with negative scores representing improvement.
Measured: Baseline to Week 12
Change in Risk-taking Behavior as Assessed by the Balloon Analogue Risk Task (BART)
BART is a computerized measure of risk taking behavior that displays a computer-generated balloon on a computer monitor. Participants gradually pump (inflate) the balloon. Each pump adds 5 cents to a temporary bank. After each pump, participants have 2 options, 1) continue to pump the balloon and risk bursting it, losing all the money from that balloon, or 2) saving the accumulated money to a permanent bank. Whenever a balloon bursts or the participant chooses to bank money, they start with a new balloon. Participants respond to 30 balloons, each having a different bursting point. With each pump, participants weigh the potential gain of collecting more money against the risk of losing all money accumulated with that balloon.
Greater number of pumps indicates greater risk taking. Change was calculated by subtracting Week 12 scores from Week 0 (baseline), with negative scores representing improvement and positive scores representing worsening risk taking.
Measured: Baseline to Week 12
Change in Decision-making Behavior as Assessed by the Iowa Gambling Task (IGT)
The Iowa Gambling Task (IGT) is a computerized assessment that evaluates decision-making by tracking the selection of advantageous or disadvantageous electronic cards from four decks. Subjects are presented the 4 decks of cards on a computer screen and are told that they can win money by picking cards from the most advantageous deck. After each deck selection, subjects are provided feedback as to whether their selection resulted in a "win" or a "loss" and the dollar amount of the win/loss. Data indicate change from baseline in mean number of cards selected from advantageous decks minus number of cards selected from disadvantageous decks as a function of drug condition. Change measured by substracting Week 0 (baseline) scores from Week 12 scores. Higher numbers indicate better decision making regarding advantageous cards.
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 posted13 Dec 2012 (estimated)
- Study startFeb 2013
- Primary completionJul 2019
- Study completionJul 2019
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 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
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, San Francisco Veterans Affairs Medical Center, Northern California Institute of Research and Education
- Responsible party
- Sponsor
- Investigators
- Steven L. Batki, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01749215
- Sponsor's protocol ID
- PT110423
- Other IDs
- W81XWH-11-PHTBI-BAPHA
- Acronym
- TAP2
- Status last verified
- May 2021
- First submitted
- 9 Nov 2012
- Last updated
- 21 Jun 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 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled Trial of Topiramate Treatment for Alcohol Dependence in Veterans With PTSD
- ClinicalTrials.gov ID
- NCT01749215
- Acronym / sponsor ID
- TAP2 / PT110423
- Keywords
- pharmacotherapy, alcohol dependence, Veterans
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- United States Department of Defense, San Francisco Veterans Affairs Medical Center, Northern California Institute of Research and Education
- Study start
- Feb 2013 (actual)
- Primary completion
- Jul 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 13 Dec 2012 (estimated)
- Results
- Posted 21 Jun 2021
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 this project is to improve the treatment of veterans with co-occurring alcohol dependence and posttraumatic stress disorder (PTSD). The PI and co-investigators will conduct a controlled clinical trial of topiramate for the treatment of these co-occurring disorders.
Detailed description
This project consists of a controlled clinical trial of topiramate treatment to reduce alcohol use and PTSD symptoms in veterans with these co-occurring disorders.
This is a prospective randomized double-blind controlled parallel groups clinical trial of topiramate or or placebo up to 300 mg per day, combined with weekly alcohol counseling, over a 12-week treatment period with a week 16 follow-up. The study population consists of 150 male and female veterans between the ages of 18-69 who have concurrent diagnoses of alcohol use disorder and PTSD. Subjects meet with research staff weekly to receive study medication, manualized alcohol counseling, and research assessments. The primary treatment outcome is the percent of days of drinking; the secondary outcome is PTSD symptom severity. Exploratory measures include assessments of impulsivity and decision-making.
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 | Drug: Topiramate, Behavioral: Medical ManagementTopiramate capsules daily - up to 300 mg |
| Placebo | Placebo comparator | Drug: placebo, Behavioral: Medical ManagementPlacebo capsules daily - up to 300 mg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male and female veterans
- Ages18 to 69 (inclusive)
- Current DSM-IV diagnosis of PTSD
- Current (past month) DSM-IV diagnosis of an Alcohol Dependence
- Level of drinking must meet criteria for "at-risk " or "heavy" drinking by NIAAA threshold (NIAAA 2007): at least 15 standard drinks per week on average over the 4 weeks prior to study entry for men and at least 8 standard drinks per week on average for women.
Key exclusion criteria (18 listed)
- Psychotic disorders, bipolar disorder, dementia, or other psychiatric disorders judged to be unstable.
- Subjects known to have clinically significant unstable medical conditions, including but not limited to:
- History of glaucoma.
- History of kidney stones.
- Concurrent participation in another treatment study.
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 |
|---|---|---|
| TopiramateExperimental study drug | Drug | Topiramate |
| placeboPlacebo comparator | Drug | Placebo |
| Medical ManagementBrief alcohol counseling | Behavioural | Placebo, Topiramate |
Primary outcome
Change in Percentage of Heavy Drinking Days Over the 12 Weeks of Study Treatment as Assessed by the Timeline Followback (TFLB)
Time frame: Baseline to Week 12
Timeline Followback (TLFB) data was recorded using a calendar, with participants providing retrospective reports of daily drinking over the past week(s). The percent of heavy drinking days per week was calculated from the calendar data. The change in percentage of heavy drinking days was calculated by subtracting Week 0 (baseline) data from Week 12. Negative scores indicate improvement.
4 secondary outcomes
Change in PTSD Symptom Severity as Assessed by the PTSD Checklist (PCL)
Time frame: Baseline to Week 12
Change in Impulsivity as Assessed by Delay Discounting (DD)
Time frame: Baseline to Week 12
Change in Risk-taking Behavior as Assessed by the Balloon Analogue Risk Task (BART)
Time frame: Baseline to Week 12
Change in Decision-making Behavior as Assessed by the Iowa Gambling Task (IGT)
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 21 Jun 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
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 Topiramate and Medical Management in people with Alcohol Dependence and Posttraumatic Stress Disorder (PTSD), 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 8 inclusion and 18 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 21 Jun 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 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 21 Jun 2021). 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 Percentage of Heavy Drinking Days Over the 12 Weeks of Study Treatment as Assessed by the Timeline Followback (TFLB) (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?
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 21 Jun 2021.