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Clinical Trial Summary

The purpose of this study to Assess the Abuse Potential of Intranasal Cebranopadol Compared to Oxycodone and Placebo in Healthy, Nondependent Recreational Opioid Users.


Clinical Trial Description

This study will be conducted to examine the intranasal abuse potential of cebranopadol compared with oxycodone HCl IR and placebo in recreational opioid users with intranasal experience, a Dose Escalation Phase (Part A) will first be conducted to determine a safe dose for evaluation in the Main Study (Part B). The Dose Selection Phase (Part A) will consist of 3 phases: Screening, Treatment and Follow-up. Subjects will participate in an outpatient medical screening visit, a 4-day treatment visit and a follow-up phone call. The Main Study (Part B) will consist of 4 phases: Screening, Qualification, Treatment and Follow-up. Subjects will participate in an outpatient screening visit, a 4-day Qualification Phase, a 30-day Treatment Phase and a follow-up phone call. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06453265
Study type Interventional
Source Tris Pharma, Inc.
Contact Liza Micioni
Phone 732-614-8073
Email clinicalaffairs@trispharma.com
Status Not yet recruiting
Phase Phase 1
Start date June 2024
Completion date March 2025

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