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NCT00000317 · ClinicalTrials.gov registry record · Phase 2

Early Phase II Trials for Cocaine Medication Development - 1

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

Completed
Registry status
Phase 2
Development phase
31
Enrollment target

NCT00000317: Completed Phase 2 study, sponsored by New York State Psychiatric Institute.

NCT00000317 is a Phase 2 study that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 31 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00000317, a Phase 2 study, has completed, sponsored by New York State Psychiatric Institute.

COMPLETED
Registry status
Phase 2
Development phase
31 participants
Enrollment target

Study Summary

The purpose of this study is to develop models for early Phase II testing of potential medications for cocaine dependence: amoxapine, risperidone and other agents. The study was a controlled pilot trial of risperidone in opiate-dependent patients on methadone maintenance. The study explored whether risperidone reduced cocaine use, cocaine craving, and cocaine subjective effects in patients on methadone maintenance who abused cocaine and whether it had an acceptable side effect profile. This

Primary Outcome

Using the Modified Systemic Assessment for Treatment Emergent Effects the psychiatrist assessed side effects

Interventions

  • DRUG Placebo
  • DRUG Risperidone
  • BEHAVIORAL Relapse prevention counseling

Trial Details

FieldValue
Enrollment Target 31 participants
Start Date 1996-08
Est. Completion 1999-07
Phase Phase 2

What the finished NCT00000317 record still lists

NCT00000317 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT00000317 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00000317 about?

NCT00000317 is a clinical study titled "Early Phase II Trials for Cocaine Medication Development - 1". The purpose of this study is to develop models for early Phase II testing of potential medications for cocaine dependence: amoxapine, risperidone and other agents. The study was a controlled pilot trial of risperidone in opiate-dependent patients on methadone maintenance. The study explored whether...

What is the current status of trial NCT00000317?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 31 participants. The study started on 1996-08. Estimated completion is 1999-07.

What interventions are being tested in trial NCT00000317?

The interventions under investigation include: Placebo (DRUG), Risperidone (DRUG), Relapse prevention counseling (BEHAVIORAL).

Who is sponsoring clinical trial NCT00000317?

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

How this trial's enrollment target compares

Where NCT00000317's enrollment target sits among peer trials

31 1578th of 2000 higher than 419 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00000317, the US trial registry maintained by the National Library of Medicine. NCT00000317 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.