Topiramate for AUD and PTSD
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: NYU Langone Health
Prior Safety Data
Approved in 5 jurisdictions
Trial Summary
What is the purpose of this trial?This is a double-blind, 2-group randomized controlled trial evaluating the effects of topiramate versus placebo in patients with comorbid PTSD and moderate-to-severe AUD. This trial will provide one of the first rigorous tests of whether the effects of topiramate in AUD generalize to patients with co-occurring PTSD, and one of the first rigorous tests of whether topiramate has beneficial effects on PTSD symptoms in this population. It will be the first study to test whether the rs2832407 genotype predicts clinical response to topiramate for AUD and PTSD in patients with both disorders. Further, it will contribute to the understanding of topiramate's mechanisms of action in the co-morbid AUD/PTSD population, and to the discovery of predictors of treatment response.
Will I have to stop taking my current medications?
The trial requires stopping certain medications that could interact negatively, such as specific anticonvulsants, metformin, and treatments for addictions. Antidepressants are allowed if the dose is stable for at least 4 weeks before the trial and remains unchanged during the study. If you're on any of these medications, you may need to stop or adjust them before participating.
What data supports the effectiveness of the drug Topiramate for treating PTSD?
Research suggests that Topiramate may help treat PTSD by reducing symptoms like nightmares and re-experiencing traumatic events. Some studies have shown it to be effective and well-tolerated in both civilian and combat-related PTSD cases.
12345Is topiramate safe for humans?
Topiramate, including its extended-release forms like Trokendi XR and Qudexy XR, has been studied for safety and tolerability in various conditions. Some studies have reported treatment-emergent adverse events (side effects that occur during treatment), but it is generally considered safe for use in humans when monitored by a healthcare provider.
13467How is the drug topiramate unique for treating AUD and PTSD?
Topiramate is unique because it may help reduce symptoms of both alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD) by affecting brain chemicals involved in these conditions. It is an anticonvulsant that works on both inhibitory and excitatory neurotransmitters, which might make it effective for PTSD, and it is being studied for its potential to reduce alcohol use in people with both disorders.
45678Eligibility Criteria
Adults aged 18-70 with both PTSD and moderate-to-severe alcohol use disorder (AUD) who want to reduce or stop drinking can join. They must be willing to use contraception if applicable, have a stable living situation, and have had several heavy drinking days recently. Excluded are those with significant health issues like liver or kidney problems, certain severe mental health conditions, recent inpatient psychiatric treatment (except for detox), current severe substance abuse other than alcohol/nicotine, or on conflicting medications.Inclusion Criteria
I am between 18 and 70 years old.
I have been diagnosed with PTSD or subPTSD according to the DSM-5.
Exclusion Criteria
I have been diagnosed with a serious mental health condition and have not had recent severe suicidal or homicidal behavior.
My liver is not working well, shown by high enzyme levels and symptoms like fatigue or pain.
My kidneys are not working well (creatinine clearance rate is below 70).
Participant Groups
The trial is testing the effectiveness of topiramate compared to a placebo in treating people who suffer from both PTSD and AUD. It's double-blind meaning neither participants nor researchers know who gets the real drug versus placebo. The study also explores whether genetic factors influence how well topiramate works for these conditions.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TopiramateExperimental Treatment1 Intervention
Week 0-1: 25 mg qhs Week 1-2: 25 mg qAM, 25 mg qhs Week 2-3: 25 mg qAM, 50 mg qhs Week 3-4: 50 mg qAM, 50 mg qhs Week 4-5: 50 mg qAM, 75 mg qhs Week 5-6: 75 mg qAM, 75 mg qhs Week 6-7: 75 mg qAM, 100 mg qhs Week 7-8: 100 mg qAM, 100 mg qhs Week 8-10: 100 mg qAM, 100 mg qhs Week 10-12: 100 mg qAM, 100 mg qhs Week 12-14: 2-week taper
Group II: PlaceboPlacebo Group1 Intervention
Placebo
Topiramate is already approved in United States, European Union, Canada, Japan, Australia for the following indications:
🇺🇸 Approved in United States as Topamax for:
- Epilepsy
- Migraine prophylaxis
- Alcohol use disorder (off-label)
- Post-traumatic stress disorder (off-label)
🇪🇺 Approved in European Union as Topamax for:
- Epilepsy
- Migraine prophylaxis
🇨🇦 Approved in Canada as Topamax for:
- Epilepsy
- Migraine prophylaxis
🇯🇵 Approved in Japan as Topamax for:
- Epilepsy
🇦🇺 Approved in Australia as Topamax for:
- Epilepsy
- Migraine prophylaxis
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
NYULHNew York, NY
New York University School of MedicineNew York, NY
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Who is running the clinical trial?
NYU Langone HealthLead Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)Collaborator
References
Treatment of civilian and combat-related posttraumatic stress disorder with topiramate. [2018]To evaluate the use of topiramate for the treatment of posttraumatic stress disorder (PTSD).
[Topiramate for the treatment of post traumatic stress disorder. A case study]. [2018]Two patients with posttraumatic stress disorder (PTSD) were treated successfully with the anti-epileptic drug topiramate. Nightmares and the re-experiencing of traumatic events were particularly responsive to the treatment. Topiramate acted rapidly at a relatively low dosage and seems to be an important addition to the limited range of drugs availablefor treating severe symptoms of PTSD.
A double-blind randomized controlled trial to study the efficacy of topiramate in a civilian sample of PTSD. [2021]To evaluate the efficacy and tolerability of topiramate in patients with posttraumatic stress disorder (PTSD).
Real-world assessment of treatment with extended-release topiramate (Trokendi XR®) and comparison with previous immediate-release topiramate treatment. [2019]Label="AIM">Examine clinical profile of extended-release topiramate (Trokendi XR®) and compare treatment-emergent adverse events (TEAEs) associated with Trokendi XR versus previous immediate-release topiramate (TPM-IR) treatment.
A randomized, double-blind, placebo-controlled trial to assess the efficacy of topiramate in the treatment of post-traumatic stress disorder. [2023]Topiramate might be effective in the treatment of posttraumatic stress disorder (PTSD) because of its antikindling effect and its action in both inhibitory and excitatory neurotransmitters. Open-label studies and few controlled trials have suggested that this anticonvulsant may have therapeutic potential in PTSD. This 12-week randomized, double-blind, placebo-controlled clinical trial will compare the efficacy of topiramate with placebo and study the tolerability of topiramate in the treatment of PTSD.
Topiramate treatment of alcohol use disorder in veterans with posttraumatic stress disorder: a randomized controlled pilot trial. [2021]The course of posttraumatic stress disorder (PTSD) is frequently and severely complicated by co-occurring alcohol use disorder (AUD), yet there are few reports of pharmacologic treatments for these comorbid conditions. The objective of this pilot study was to obtain a preliminary assessment of the efficacy and safety of topiramate in reducing alcohol use and PTSD symptoms in veterans with both disorders.
USL255 extended-release topiramate: dose-proportional pharmacokinetics and tolerability in healthy volunteers. [2021]Evaluate the pharmacokinetics (PK), safety, and tolerability of single doses of once-daily USL255, Qudexy XR (topiramate) extended-release capsules, over a wide dosing range.
Therapeutic drug monitoring of topiramate with a new HPLC method, SPE extraction and high sensitivity pre-column fluorescent derivatization. [2019]Topiramate is a 2nd generation antiepileptic drug (AED) recently approved by the FDA for migraine prophylaxis. Its pharmacological activity already appears significant at low doses. Unfortunately, the difficulty in determining the drug in serum at low concentrations hampers the completion of accurate pharmacokinetic studies in humans. Only chromatographic methods allow reaching the necessary sensitivities.