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Topiramate for AUD and PTSD
Study Summary
This trial is testing whether the drug topiramate can help people who have both PTSD and AUD. It will be the first study to see if the rs2832407 genotype predicts how well someone does on topiramate.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2017 Phase 4 trial • 282 Patients • NCT02191579Trial Design
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- You are currently being treated for addiction to methadone or opioids.You are allergic or have a bad reaction to topiramate.My kidneys are not working well (creatinine clearance rate is below 70).You want to reduce or quit drinking alcohol.You have consumed at least four or more alcoholic drinks per day (for women) or five or more alcoholic drinks per day (for men) on at least four days within the past 30 days.I have been diagnosed with PTSD or subPTSD according to the DSM-5.I have not been hospitalized for psychiatric reasons in the past year, except for detox.My liver is not working well, shown by high enzyme levels and symptoms like fatigue or pain.I started psychotherapy for PTSD or another mental health condition within the last 3 months.I have been diagnosed with a serious mental health condition and have not had recent severe suicidal or homicidal behavior.I am not taking any medication that could badly interact with the study drugs.I am between 18 and 70 years old.I am not currently receiving new treatment for alcohol use disorder, except for AA/12-step or psychosocial treatments started over 2 months ago.You have had a serious head injury in the past, or a less severe head injury in the past year with certain symptoms that will be evaluated by the study team.You have experienced a traumatic event, such as a physical injury or being in the military or police, within the past 30 days.
- Group 1: Placebo
- Group 2: Topiramate
- 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
Is the eligibility threshold for this trial capped at seventy-five years?
"To be eligible for this medical experiment, potential participants must fall between 18 and 70 years of age. Clinicialtrials.gov indicates that there are 324 studies available to those younger than 18 and 1068 trials open to seniors beyond 65 years old."
Are more participants being solicited for this experiment?
"Affirmative. The information on clinicaltrials.gov reveals that this trial, first posted in October 16th 2019, is actively searching for participants. 150 volunteers need to be enrolled from a single site."
Who is eligible to become a participant in this medical experiment?
"This clinical trial requires 150 individuals with stress-induced traumatic histories that are 18 and 70 years of age. Most notably, applicants should have had at least 4 days (4 for women, 5 for men) where they drank heavily in the month prior to screening while also expressing a desire to decrease or end their consumption. Furthermore, two reliable contacts must be provided as reference points."
How many participants have been accepted into this medical study?
"Affirmative. According to medical records hosted on clinicaltrials.gov, this research initiative is currently recruiting participants with the initial post dating back to October 16th 2019 and most recent update being September 27th 2022. There are 1 sites looking for a total of 150 volunteers."
What indications is Topiramate typically prescribed for?
"Topiramate is a commonly prescribed medication used to treat hypertension, migraines and epilepsy. Additionally, this drug may be taken as countermeasure for obesity-related comorbidities."
Has Topiramate been certified by the Food and Drug Administration?
"Our medical researchers at Power have judged the safety of Topiramate to be a 2, as there is some evidence in Phase 2 trials that it is safe but no data demonstrating efficacy."
Have there been any other investigations involving the use of Topiramate?
"Currently, there are 18 active studies researching the effects of Topiramate with 3 trials in Phase 3. Despite most locations for these experiments being situated around Sherbrooke, Quebec; 30 sites are participating total."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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