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Principal Investigator was deployed overseas
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| Name | Class |
|---|---|
| US Department of Veterans Affairs | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topiramate | Experimental | Topiramate arm will be titrated (dose will increase slowly) over 6 weeks to 400mg or highest tolerated dose. |
|
| Placebo (Sugar Pill) | Placebo Comparator | Placebo arm will receive matching capsules without topiramate. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topiramate | Drug | Topiramate titrated over 6 weeks to 400mg or highest tolerated dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bernard A Fischer, M.D. | Department of Veterans Affairs, University of Maryland School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baltimore VA, VA Maryland Health Care System | Baltimore | Maryland | 21201 | United States |
Three participants were withdrawn prior to assignment to a treatment group. Two did not return for study visits after signing consent and one did not meet eligibility criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | Topiramate | Topiramate arm will be titrated (dose will increase slowly) over 6 weeks to 400mg or highest tolerated dose. Topiramate: Topiramate titrated over 6 weeks to 400mg or highest tolerated dose. |
| FG001 | Placebo (Sugar Pill) | Placebo arm will receive matching capsules without topiramate. Placebo: Placebo capsules without topiramate |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Topiramate | Topiramate arm will be titrated (dose will increase slowly) over 6 weeks to 400mg or highest tolerated dose. Topiramate: Topiramate titrated over 6 weeks to 400mg or highest tolerated dose. |
| BG001 | Placebo (Sugar Pill) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | There were not enough interested, eligible participants available to continue the study. Additionally, the study drug expired and the pharmacy that had done the compounding was bought by a larger chain and was set to be closed. Therefore, the study was stopped and closed in April 2013. | Posted | 14 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Topiramate | Topiramate arm will be titrated (dose will increase slowly) over 6 weeks to 400mg or highest tolerated dose. Topiramate: Topiramate titrated over 6 weeks to 400mg or highest tolerated dose. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal ideation | Psychiatric disorders | Non-systematic Assessment | Subject evaluated by the PI and VA emergency department but was not admitted. Subject stopped taking study medication so determined not related to study drug or placebo. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bernard Fischer, M.D. | FDA | 240-402-4511 | Bernard.Fischer@fda.hhs.gov |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000077236 | Topiramate |
| ID | Term |
|---|---|
| D005632 | Fructose |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 |
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| Placebo | Drug | Placebo capsules without topiramate |
|
| 14 weeks |
Placebo arm will receive matching capsules without topiramate.
Placebo: Placebo capsules without topiramate
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Placebo (Sugar Pill) | Placebo arm will receive matching capsules without topiramate. Placebo: Placebo capsules without topiramate |
|
| Secondary | 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. | There were not enough interested, eligible participants available to continue the study. Additionally, the study drug expired and the pharmacy that had done the compounding was bought by a larger chain and was set to be closed. Therefore, the study was stopped and closed in April 2013. | Posted | 14 weeks |
|
|
| 0 |
| 1 |
| 1 |
| 1 |
| EG001 | Placebo (Sugar Pill) | Placebo arm will receive matching capsules without topiramate. Placebo: Placebo capsules without topiramate | 0 | 0 | 0 | 0 |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment | Severe nausea determined possibly related to study drug. |
|
| Dizziness | Ear and labyrinth disorders | Systematic Assessment | Moderate dizziness determined to be possibly related to study drug. |
|
| Stiffness | Musculoskeletal and connective tissue disorders | Systematic Assessment | Moderate stiffness determined to be possibly related to study drug. |
|
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| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| Carbohydrates |
| D007661 | Ketoses |