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topiramate for Post-Traumatic Stress Disorder and Alcohol Use Disorder (TOP Trial)
Phase 2 & 3
Waitlist Available
Led By Sonya B. Norman, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to 16 weeks
Awards & highlights
TOP Trial Summary
This trial is testing whether a medication called topiramate, which is used to both reduce drinking and PTSD symptoms, is more effective than a placebo at improving treatment outcomes for Veterans with AUD and PTSD.
Eligible Conditions
- Post-Traumatic Stress Disorder and Alcohol Use Disorder
TOP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline to 16 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to 16 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
CAPS-5 Change
Timeline Followback Interview (TLFB)
Side effects data
From 2013 Phase 4 trial • 200 Patients • NCT0062692554%
Numbness/Tingling
37%
Change in taste
27%
Tireness/Sleepiness
24%
Difficulty with memory
24%
Loss of appetite
22%
Headache
21%
Diarrehea
19%
Weight loss
18%
Difficulty Concentrating
16%
Dry Mouth
10%
Nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Topiramate Group
Placebo Group
TOP Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: prolonged exposure + topiramateExperimental Treatment2 Interventions
psychotherapy plus active medication
Group II: prolonged exposure + placeboActive Control2 Interventions
psychotherapy plus placebo medication
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
topiramate
2008
Completed Phase 4
~2040
prolonged exposure
2017
Completed Phase 3
~100
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,503 Total Patients Enrolled
University of California, San DiegoOTHER
1,120 Previous Clinical Trials
1,521,535 Total Patients Enrolled
Sonya B. Norman, PhDPrincipal InvestigatorVA San Diego Healthcare System, San Diego, CA
3 Previous Clinical Trials
514 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have taken Topiramate before but had to stop because you had a bad allergic reaction to it.The doctor thinks you might be at risk of hurting yourself or others.You are not currently participating in therapy that focuses on addressing trauma.You are currently trying to drink less alcohol or stop drinking altogether.You have been drinking heavily (5 or more drinks per day for men, 4 or more drinks per day for women) for at least 20 days in the past 90 days, and have continued heavy drinking on at least 4 days in the past 30 days.You have a condition that causes seizures.You have experienced a really upsetting event that meets certain criteria, and it has been at least one month since it happened.You are willing to participate in therapy, take medication, and attend regular check-up appointments.
Research Study Groups:
This trial has the following groups:- Group 1: prolonged exposure + topiramate
- Group 2: prolonged exposure + placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
For what disorders is topiramate commonly prescribed?
"Topiramate is a medication that's used to manage hypertension. This drug can also help with other problems like preventing migraines, epilepsy, and obesity."
Answered by AI
Are people with the target condition able to sign up for this research study at this time?
"That is accurate. The information available on clinicaltrials.gov verifies that this study, which was first advertised on November 1st 2017, is currently looking for test subjects. In total, 120 individuals are needed at a single location."
Answered by AI
What else is topiramate being looked at for in other research projects?
"The current status of topiramate clinical trials is 19 live studies with 3 in Phase 3. The province of Quebec, Sherbrooke specifically, has the majority of these trials taking place. That being said, there are 31 locations for these studies in total."
Answered by AI
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