Topiramate for Alcoholism

Phase-Based Progress Estimates
New York University School of Medicine, New York, NYAlcoholism+1 MoreTopiramate - Drug
18 - 70
All Sexes
What conditions do you have?

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.

Eligible Conditions
  • Post Traumatic Stress Disorder
  • Alcoholism

Treatment Effectiveness

Study Objectives

3 Primary · 0 Secondary · Reporting Duration: Week 9 to Week 12

Day 1
Measure of Time-line Follow-back (TLFB)
Week 12
PCL-5 score
Percent Day Abstinent from Alcohol

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

13%Cognitive Disorder
11%Decreased appetite
8%Vision blurred
8%Distubance in attention
1%Peripheral arterial occlusive disease
1%Chronic obstructive pulmonary disease
1%Road traffic accident
1%Deep vein thrombosis
This histogram enumerates side effects from a completed 2017 Phase 4 trial (NCT02191579) in the Topiramate ARM group. Side effects include: Paraesthesia with 31%, Cognitive Disorder with 13%, Nausea with 13%, Fatigue with 13%, Dizziness with 13%.

Trial Design

2 Treatment Groups

1 of 2
1 of 2

Experimental Treatment

Non-Treatment Group

150 Total Participants · 2 Treatment Groups

Primary Treatment: Topiramate · Has Placebo Group · Phase 2

Experimental Group · 1 Intervention: Topiramate · Intervention Types: Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other
First Studied
Drug Approval Stage
How many patients have taken this drug
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: week 9 to week 12

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,279 Previous Clinical Trials
759,645 Total Patients Enrolled
9 Trials studying Alcoholism
990 Patients Enrolled for Alcoholism
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
732 Previous Clinical Trials
1,339,606 Total Patients Enrolled
383 Trials studying Alcoholism
978,519 Patients Enrolled for Alcoholism
Charles Marmar, MDPrincipal InvestigatorNYU Langone Health
7 Previous Clinical Trials
180 Total Patients Enrolled
1 Trials studying Alcoholism
95 Patients Enrolled for Alcoholism

Eligibility Criteria

Age 18 - 70 · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You express a wish to reduce or quit drinking.
You have had 4 or more alcoholic drinks per day if you're a woman or 5 or more drinks per day if you're a man in the 30 days before the screening.

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. indicates that there are 324 studies available to those younger than 18 and 1068 trials open to seniors beyond 65 years old." - Anonymous Online Contributor

Unverified Answer

Are more participants being solicited for this experiment?

"Affirmative. The information on 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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

How many participants have been accepted into this medical study?

"Affirmative. According to medical records hosted on, 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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.