CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 16 enrolled
Drug / intervention
Intravenous Challenge Drugdrug
Likely dose
Not stated in 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/NCT03389750
NCT03389750Phase 2Completed

A Randomized, Double-Blind, Placebo- and Active-Controlled, Crossover Study to Evaluate the Abuse Potential of Oxymorphone Compared to Other Mu Opioid Agonists in Physically Dependent Opioid Users With Moderate-to-Severe Opioid Use Disorder

New York State Psychiatric Institute·interventional·Posted Jan 4, 2018·Updated Sep 7, 2023

In Brief

A Phase 2 clinical trial evaluating Intravenous Challenge Drug for Opioid Use Disorder. Completed, enrolled 16 participants across 2 sites.

Detailed Summary

Significant public health concerns have arisen from the intravenous misuse of oxymorphone, a potent mu-opioid pain medication. However, little is known about its abuse potential relative to other mu-opioid analgesics. The present study is designed to examine the abuse liability of intravenous oxymorphone compared to other mu opioid agonists (oxycodone, and hydromorphone) among physically dependent opioid abusers.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJan 4, 2018
Enrollment StartMar 15, 2018
Primary CompletionJun 15, 2022
Study CompletionJun 28, 2023
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 8.5 years ago

Interventions

Intravenous Challenge Drugdrug

Intravenous administration of opioid drugs (oxycodone, oxymorphone, hydromorphone), for the purpose of comparison of their abuse potential among each other, and in comparison to placebo (saline).