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NCT02371889 · ClinicalTrials.gov registry record · Phase 2
A Randomized, Double-blind Placebo-Controlled Pharmacogenetic Study of Topiramate in European-American Heavy Drinkers
A Phase 2 study of Alcoholism and Alcohol Use Disorder (AUD), sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 2
- Development phase
- 320
- Enrollment target
- 2
- Study locations
NCT02371889: Completed Phase 2 study of Alcoholism and Alcohol Use Disorder (AUD), sponsored by University of Pennsylvania.
NCT02371889 is a Phase 2 study of Alcoholism and Alcohol Use Disorder (AUD) that has completed, run by University of Pennsylvania. The registered enrollment target is 320 participants, below the 370-participant average among 65 other Alcoholism trials with a reported enrollment target (14% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02371889, a Phase 2 study of Alcoholism and Alcohol Use Disorder (AUD), has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 320 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study is to advance the effort to develop personalized pharmacotherapy for alcohol use disorders (AUDs). The investigators propose to conduct a 12-week, prospective, randomized clinical trial of the moderating effect of rs2832407 on the efficacy of TOP in reducing heavy drinking (HD) in 200 individuals of European descent with DSM-5 AUD. The investigators will stratify the randomization on genotype and oversample rs2832407\*C homozygotes, the most TOP-responsive genotype, to ensure comparable numbers of patients in the four medication x genotype groups. The investigators will use daily data collection to examine changes in relevant process variables (e.g., alcohol expectancies) and their interaction with genotype and medication group as predictors of HD. The proposed study is innovative in that it will be the first prospective test of a pharmacogenetic hypothesis involving TOP; it will use daily reports to examine expectancies and how they interact with medication and genotype to predict HD; and it will enroll DSM-5 AUD patients whose goal is either to reduce or stop drinking, which will increase the study's external validity.
Primary Outcome
The number of Heavy Drinking Days during 12 weeks of treatment in the topiramate and placebo groups.
Conditions Studied
Interventions
- BEHAVIORAL Medical Management
- DRUG Topiramate
- DRUG Inactive Placebo
Study Locations (2)
Pennsylvania
- Corporal Michael J. Crescenz VA Medical Center - Philadelphia
- University of Pennsylvania Treatment Research Center - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 320 participants |
| Start Date | 2014-12-18 |
| Est. Completion | 2020-02 |
| Phase | Phase 2 |
What the finished NCT02371889 record still lists
NCT02371889 is an interventional study that assigns participants to a tested intervention. The registered 320 participants enrollment target is mid-sized for trials with a published cap, below the 370-participant average among 65 other Alcoholism trials with a reported enrollment target (14% lower).
The record links to 2 conditions, with Alcoholism appearing as the primary indexed condition, and to 3 interventions - of which Medical Management is the first listed.
NCT02371889 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT02371889 about?
NCT02371889 is a clinical study titled "A Randomized, Double-blind Placebo-Controlled Pharmacogenetic Study of Topiramate in European-American Heavy Drinkers". The purpose of this study is to advance the effort to develop personalized pharmacotherapy for alcohol use disorders (AUDs). The investigators propose to conduct a 12-week, prospective, randomized clinical trial of the moderating effect of rs2832407 on the efficacy of TOP in reducing heavy drinking ...
What is the current status of trial NCT02371889?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 320 participants. The study started on 2014-12-18. Estimated completion is 2020-02.
What conditions does trial NCT02371889 study?
This clinical trial studies the following conditions: Alcoholism, Alcohol Use Disorder (AUD).
What interventions are being tested in trial NCT02371889?
The interventions under investigation include: Medical Management (BEHAVIORAL), Topiramate (DRUG), Inactive Placebo (DRUG).
Who is sponsoring clinical trial NCT02371889?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02371889 being conducted?
This trial has 2 study locations across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02371889's enrollment target sits among peer trials
320 11th of 65 higher than 55 of 65 other Alcoholism trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alcoholism trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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