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| ID | Type | Description | Link |
|---|---|---|---|
| W81XWH-11-PHTBI-BAPHA | Other Identifier | Department of Defense |
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
| San Francisco Veterans Affairs Medical Center | FED |
| Northern California Institute of Research and Education | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topiramate | Experimental | Topiramate capsules daily - up to 300 mg |
|
| Placebo | Placebo Comparator | Placebo capsules daily - up to 300 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topiramate | Drug | Experimental study drug |
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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.
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.
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| Name | Affiliation | Role |
|---|---|---|
| Steven L. Batki, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco VA Medical Center | San Francisco | California | 94121 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Topiramate | Topiramate capsules daily - up to 300 mg Topiramate: Experimental study drug Medical Management: Brief alcohol counseling |
| FG001 | Placebo | Placebo capsules daily - up to 300 mg placebo: Placebo comparator Medical Management: Brief alcohol counseling |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Topiramate | Topiramate capsules daily - up to 300 mg Topiramate: Experimental study drug Medical Management: Brief alcohol counseling |
| BG001 | Placebo | Placebo capsules daily - up to 300 mg placebo: Placebo comparator Medical Management: Brief alcohol counseling |
| 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 | 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. | Posted | Mean | Standard Deviation | percent heavy drinking days | Baseline to Week 12 |
|
Over 16 weeks.
We used the Adverse Event Symptom Checklist at every study visit (Visits 0 - 12 and 16), which assessed the most reported adverse events listed in the FDA Prescribing Information.
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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 capsules daily - up to 300 mg Topiramate: Experimental study drug Medical Management: Brief alcohol counseling |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inpatient hospitalization of less than 24 hours with diagnosis of Type 2 MI | Cardiac disorders | Systematic Assessment | This happened in the context of cocaine and methamphetamine use, with discharge within 24 hours. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Numbness or tingling | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Steven L. Batki | University of California, San Francisco/San Francisco VA Healthcare System | 415-221-4810 | 23671 | steven.batki@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 7, 2018 | Apr 16, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 29, 2019 | Apr 16, 2021 | ICF_001.pdf |
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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 |
| D011216 | Practice Management, Medical |
| ID | Term |
|---|---|
| D005632 | Fructose |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 |
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| Drug |
Placebo comparator |
|
| Medical Management | Behavioral | Brief alcohol counseling |
|
| 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. | 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. | 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. | Baseline to Week 12 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| 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 |
|
Placebo capsules daily - up to 300 mg placebo: Placebo comparator Medical Management: Brief alcohol counseling |
|
|
| Secondary | 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. | Data were only collected for N=42 for the Topiramate arm and N=49 for the Placebo arm, as reported here. | Posted | Mean | Standard Deviation | score on a scale | Baseline to Week 12 |
|
|
|
| Secondary | 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. | Data were only collected for N=22 for the Topiramate arm and N=16 for the Placebo arm, as reported here. | Posted | Mean | Standard Deviation | K-value | Baseline to Week 12 |
|
|
|
| Secondary | 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. | Data were only collected for N=43 for the Topiramate arm and N=46 for the Placebo arm, as reported here. | Posted | Mean | Standard Deviation | Total pumps | Baseline to Week 12 |
|
|
|
| Secondary | 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. | Data were only collected for N=31 for the Topiramate arm and N=34 for the Placebo arm, as reported here. | Posted | Mean | Standard Deviation | test cards | Baseline to Week 12 |
|
|
|
| 0 |
| 72 |
| 2 |
| 72 |
| 70 |
| 72 |
| EG001 | Placebo | Placebo capsules daily - up to 300 mg placebo: Placebo comparator Medical Management: Brief alcohol counseling | 1 | 79 | 9 | 79 | 79 | 79 |
|
| Inpatient medical hospitalization for alcohol withdrawal. | Nervous system disorders | Systematic Assessment |
|
| Inpatient psychiatric hospitalization | Psychiatric disorders | Systematic Assessment | Participant reported increased suicidal ideation and was willing to voluntarily go to psych emergency services (PES) at the SFVAMC. PES staff conducted their own assessment and concluded inpatient psychiatric hospitalization would be beneficial. |
|
| Inpatient psychiatric hospitalization | Psychiatric disorders | Systematic Assessment | The participant voluntarily presented at PES at SFVAMC looking for housing. During routine assessment, participant reported cocaine use, hopelessness and thoughts of self-harm without a specific plan. Determined that needed to be admitted to PICU. |
|
| Inpatient medical hospitalization due to abdominal pain | Gastrointestinal disorders | Systematic Assessment | The participant was brought by ambulance to the emergency department because of abdominal pain and vomiting. Participant has history of multiple bowel obstructions. |
|
| Death of research participant | General disorders | Systematic Assessment | Coroner's report on cause of death: cocaine toxicity |
|
| Inpatient hospitalization due to congestive heart failure | Cardiac disorders | Systematic Assessment | Thought to be secondary to hypertension and chronic alcohol use. |
|
| Inpatient hospitalization due to suicidal ideation and alcohol withdrawal | Psychiatric disorders | Systematic Assessment |
|
| Inpatient hospitalization due to shortness of breath in the setting of abdominal distension | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Participant was experiencing increased shortness of breath in the setting of abdominal distension and 20 pound weight gain over 3 months. Discharge diagnosis was COPD and lactose intolerance. |
|
| Inpatient hospitalization for lower quadrant pain, cough and chills | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | It was found that participant had a fever, increased white blood cells, and his lungs were filled with liquid. Veteran was prescribed amoxicillin and clavulonic acid for 7 days to treat aspiration pneumonia. |
|
| Inpatient hospitalization for pancreatitis | Gastrointestinal disorders | Systematic Assessment |
|
| Inpatient hospitalization for MRSA | Infections and infestations | Systematic Assessment |
|
| Change in sense of taste | Nervous system disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Loss of appetite | Gastrointestinal disorders | Systematic Assessment |
|
| Difficulty with concentration or attention | Nervous system disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Dizziness | Ear and labyrinth disorders | Systematic Assessment |
|
| Itching | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Sleepiness | General disorders | Systematic Assessment |
|
| Slow thinking | Nervous system disorders | Systematic Assessment |
|
| Abnormal vision | Eye disorders | Systematic Assessment |
|
| Eye pain | Eye disorders | Systematic Assessment |
|
| Confusion | Nervous system disorders | Systematic Assessment |
|
| Language problems (e.g., word searching) | Nervous system disorders | Systematic Assessment |
|
| Depression | Psychiatric disorders | Systematic Assessment |
|
| Suicidal thoughts or actions | Psychiatric disorders | Systematic Assessment |
|
| Nervousness | Psychiatric disorders | Systematic Assessment |
|
| Difficulty with memory | Nervous system disorders | Systematic Assessment |
|
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| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| Carbohydrates |
| D007661 | Ketoses |
| D020399 | Practice Management |
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |