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NCT01811940 · ClinicalTrials.gov registry record · Phase 2

Multicenter Trial of Combined Pharmacotherapy to Treat Cocaine Dependence

A Phase 2 study of Cocaine Dependence, sponsored by New York State Psychiatric Institute.

Completed
Registry status
Phase 2
Development phase
169
Enrollment target
2
Study locations

NCT01811940 is a Phase 2 study of Cocaine Dependence that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 169 participants, below the 294-participant average among 38 other Cocaine Dependence trials with a reported enrollment target (43% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT01811940, a Phase 2 study of Cocaine Dependence, has completed, sponsored by New York State Psychiatric Institute.

COMPLETED
Registry status
Phase 2
Development phase
169 participants
Enrollment target
2
Study locations

Study Summary

The proposed protocol is a multi-site double-blind, placebo-controlled outpatient study of the safety and efficacy of Adderall-XR (MAS-ER) and topiramate in the treatment of cocaine dependence. 198 patients will be enrolled and 176 patients randomized in a 14-week trial. The proportion of participants achieving sustained cocaine abstinence for three consecutive weeks at the end of the study will be significantly greater for the combined pharmacotherapies group compared to the placebo group.

Conditions Studied

Cocaine Dependence

Interventions

  • OTHER Placebo
  • DRUG Topiramate
  • DRUG Adderall-ER

Study Locations (2)

New York

  • STARS - New York

Pennsylvania

  • University of Pennsylvania - Philadelphia

Trial Details

FieldValue
Enrollment Target 169 participants
Start Date 2013-07
Est. Completion 2017-06
Phase Phase 2

Sponsor

New York State Psychiatric Institute

364 total trials

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What the Registry Record Tells You About NCT01811940

The ClinicalTrials.gov registry entry for NCT01811940 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 169 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 294-participant average among 38 other Cocaine Dependence trials with a reported enrollment target (43% lower). The listed sponsor is New York State Psychiatric Institute, which has 364 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Cocaine Dependence appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT01811940 reports 2 study locations spanning 2 distinct geographic areas - top geographies include New York, Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT01811940 about?

NCT01811940 is a clinical study titled "Multicenter Trial of Combined Pharmacotherapy to Treat Cocaine Dependence". The proposed protocol is a multi-site double-blind, placebo-controlled outpatient study of the safety and efficacy of Adderall-XR (MAS-ER) and topiramate in the treatment of cocaine dependence. 198 patients will be enrolled and 176 patients randomized in a 14-week trial. The proportion of participan...

What is the current status of trial NCT01811940?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 169 participants. The study started on 2013-07. Estimated completion is 2017-06.

What conditions does trial NCT01811940 study?

This clinical trial studies the following conditions: Cocaine Dependence.

What interventions are being tested in trial NCT01811940?

The interventions under investigation include: Placebo (OTHER), Topiramate (DRUG), Adderall-ER (DRUG).

Who is sponsoring clinical trial NCT01811940?

This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01811940 being conducted?

This trial has 2 study locations across New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.