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NCT01486810 · ClinicalTrials.gov registry record · Phase 1

Open-Label Pilot Study of Lisdexamfetamine for Cocaine Dependence

A Phase 1 study of Cocaine Dependence, sponsored by New York State Psychiatric Institute.

Completed
Registry status
Phase 1
Development phase
17
Enrollment target
1
Study location

NCT01486810 is a Phase 1 study of Cocaine Dependence that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 17 participants, below the 298-participant average among 38 other Cocaine Dependence trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01486810, a Phase 1 study of Cocaine Dependence, has completed, sponsored by New York State Psychiatric Institute.

COMPLETED
Registry status
Phase 1
Development phase
17 participants
Enrollment target
1
Study location

Study Summary

The proposed protocol is an open-label pilot study of the treatment of cocaine dependence using lisdexamfetamine (LDX), a prodrug of d-amphetamine. The investigators plan to enroll 12 patients in an eight-week open-label trial to obtain preliminary data regarding the safety, tolerability, and potential utility of lisdexamfetamine for treatment of cocaine dependence and to determine an effective dosage range.

Conditions Studied

Cocaine Dependence

Interventions

  • DRUG Lisdexamfetamine
  • BEHAVIORAL medication management

Study Locations (1)

New York

  • STARS - New York

Trial Details

FieldValue
Enrollment Target 17 participants
Start Date 2011-12
Est. Completion 2013-12
Phase Phase 1

Sponsor

New York State Psychiatric Institute

364 total trials

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What the Registry Record Tells You About NCT01486810

The ClinicalTrials.gov registry entry for NCT01486810 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 298-participant average among 38 other Cocaine Dependence trials with a reported enrollment target (94% 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 2 interventions - of which Lisdexamfetamine is the first listed.

NCT01486810 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.

Frequently Asked Questions

What is clinical trial NCT01486810 about?

NCT01486810 is a clinical study titled "Open-Label Pilot Study of Lisdexamfetamine for Cocaine Dependence". The proposed protocol is an open-label pilot study of the treatment of cocaine dependence using lisdexamfetamine (LDX), a prodrug of d-amphetamine. The investigators plan to enroll 12 patients in an eight-week open-label trial to obtain preliminary data regarding the safety, tolerability, and potent...

What is the current status of trial NCT01486810?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2011-12. Estimated completion is 2013-12.

What conditions does trial NCT01486810 study?

This clinical trial studies the following conditions: Cocaine Dependence.

What interventions are being tested in trial NCT01486810?

The interventions under investigation include: Lisdexamfetamine (DRUG), medication management (BEHAVIORAL).

Who is sponsoring clinical trial NCT01486810?

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

Where is trial NCT01486810 being conducted?

This trial has 1 study location across New York. 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.