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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 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.

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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.

Conditions Studied

Alcoholism Alcohol Use Disorder (AUD)

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

FieldValue
Enrollment Target 320 participants
Start Date 2014-12-18
Est. Completion 2020-02
Phase Phase 2

Sponsor

University of Pennsylvania

1,423 total trials

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What the Registry Record Tells You About NCT02371889

The ClinicalTrials.gov registry entry for NCT02371889 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 320 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 370-participant average among 65 other Alcoholism trials with a reported enrollment target (14% lower). The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.

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 2 study locations spanning 1 distinct geographic area - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.