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NCT01395797 · ClinicalTrials.gov registry record · Phase 1

Pioglitazone for Heroin and for Nicotine Dependence

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

Terminated
Registry status
Phase 1
Development phase
82
Enrollment target

NCT01395797: Clinical Trial Phase 1 study, sponsored by New York State Psychiatric Institute.

NCT01395797 is a Phase 1 study that was terminated before completion, run by New York State Psychiatric Institute. The registered enrollment target is 82 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01395797, a Phase 1 study, was terminated before completion, sponsored by New York State Psychiatric Institute.

TERMINATED
Registry status
Phase 1
Development phase
82 participants
Enrollment target

Study Summary

The goal of the proposed research is to improve the effectiveness of treatments for opioid and for nicotine dependence by testing a novel pharmacological strategy. Specifically, pioglitazone, a peroxisome proliferator-activated gamma receptor (PPARγ) agonist, will be used as an adjunct to agonist-based treatment.

Primary Outcome

Number of operant responses (mouse clicks) participants were willing to provide in order to receive the drug under investigation (heroin or nicotine). The Breakpoint is the point at which participants stopped responding for the drug, i.e., the total number of clicks they were willing to provide in order to receive the drug.

Interventions

  • DRUG Placebo
  • DRUG PIO

Trial Details

FieldValue
Enrollment Target 82 participants
Start Date 2011-03
Est. Completion 2014-06
Phase Phase 1

Why NCT01395797 stopped before completion

NCT01395797 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 82 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% higher).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01395797 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01395797 about?

NCT01395797 is a clinical study titled "Pioglitazone for Heroin and for Nicotine Dependence". The goal of the proposed research is to improve the effectiveness of treatments for opioid and for nicotine dependence by testing a novel pharmacological strategy. Specifically, pioglitazone, a peroxisome proliferator-activated gamma receptor (PPARγ) agonist, will be used as an adjunct to agonist-ba...

What is the current status of trial NCT01395797?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 82 participants. The study started on 2011-03. Estimated completion is 2014-06.

What interventions are being tested in trial NCT01395797?

The interventions under investigation include: Placebo (DRUG), PIO (DRUG).

Who is sponsoring clinical trial NCT01395797?

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 NCT01395797's enrollment target sits among peer trials

82 669th of 2000 higher than 1,330 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT01395797, the US trial registry maintained by the National Library of Medicine. NCT01395797 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.