CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 32 enrolled
Drug / intervention
pioglitazonedrug
Likely dose
pioglitazone 15 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01395784
NCT01395784Phase 2Completed
CompareCT.gov

Effects of Pioglitazone, a PPARgamma Receptor Agonist, on the Abuse Liability of Oxycodone

New York State Psychiatric Institute·interventional·Posted Jul 18, 2011·Updated Feb 23, 2016

In Brief

A Phase 2 clinical trial evaluating pioglitazone for Opioid Abuse. Completed, enrolled 32 participants across 1 site.

Detailed Summary

The ability of pioglitazone (PIO) to alter the effects of opioids in humans has not been characterized in a controlled laboratory setting. Accordingly, the proposed investigation seeks to examine the effects of PIO on oxycodone, one of the most commonly used and abused opioid drugs in the U.S. (Davis et al., 2003). More specifically, the primary aim of this investigation is to characterize the subjective effects of oxycodone under maintenance on various doses of PIO (0, 15, and 45 mg) in non-dependent, prescription opioid abusers. Secondary aims of the study are to examine the influence of PIO on the analgesic, cognitive, and physiological effects of oxycodone.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpioid Abuse
CountriesUnited States
CollaboratorsOmeros Corporation

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 18, 2011
Enrollment StartAug 1, 2010
Primary CompletionJan 1, 2014
Study CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 15.0 years ago

Interventions

pioglitazonedrug

A PPARγ agonist, also marketed as Actos. Participants will be maintained on ascending doses of Placebo, pioglitazone 15 mg and 45 mg, prior to completing a lab session at the end of each dosing period.