NCT03389750

A Study to Evaluate the Abuse Potential of Oxymorphone Compared to Other Mu Opioid Agonists.

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: New York State Psychiatric Institute · Academic / Other
• Sex: All
• Age: 21 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Significant public health concerns have arisen from the misuse of oxymorphone, a potent mu-opioid pain medication approved by the Food and Drug Administration as Opana and Opana ER. 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). Participants who are physically dependent on opioids and who meet DSM 5 criteria for Opioid Use Disorder will complete the study across 2 sites, New York State Psychiatric Institute (NYSPI) and the University of Kentucky; a total of 6 additional participants across 2 sites will complete a pilot phase of the study in order to establish comparable opioid dose-response functions based on subjective ratings of Drug Liking. All participants will reside in clinical inpatient units for the duration of the studies (both the 8- to 9-week main and 4- to 5-week pilot studies; please note that the pilot study is identical in design to the first 4-5 weeks of the main study). The study design is based on the 2017 FDA Assessment of Abuse Potential of Drugs: Guidance for Industry \[Center for Drug Evaluation and Research (CDER), 2017\], which suggests the use of a double-blind, positive- and placebo-controlled design that includes a qualification phase and VAS measure of Drug Liking. The proposed study also examines the reinforcing effects of oxymorphone and other mu opioid agonists using two different drug self-administration procedures, namely Drug versus Money and Drug versus Drug choice procedures.

Conditions

• Opioid Use Disorder

Interventions

Type	Name	Description
DRUG	Intravenous Challenge Drug	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).

Timeline

• Start date: 2018-03-15
• Primary completion: 2022-06-15
• Completion: 2023-06-28
• First posted: 2018-01-04
• Last updated: 2023-09-07
• Results posted: 2023-09-07

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study