NCT06453265

A Study to Assess the Abuse Potential of Intranasal Cebranopadol

A Double-Blind, Randomized, Crossover Study to Assess the Abuse Potential of Intranasal Cebranopadol Compared to Oxycodone and Placebo in Healthy, Nondependent Recreational Opioid Users

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Tris Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Abuse, Drug

Interventions

Type	Name	Description
DRUG	Cebranopadol- 600 ug	Dose ascending cohorts \- Cebranopadol 600 ug single dose
DRUG	Cebranopadol- 800ug	Dose ascending cohorts \- Cebraopadol 800 ug single dose
DRUG	Cebranopadol- 1000ug	Dose ascending cohorts \- Cebranopadol 1000 ug single dose
DRUG	Treatment A:	Cebranopadol, dose determined in Part A
DRUG	Treatment B	Oxycodone HCl IR 40 mg
DRUG	Treatment C	Placebo
DRUG	Qualification	Oxycodone 40mg
DRUG	Qualification	Matching Placebo

Timeline

• Start date: 2024-06-28
• Primary completion: 2024-11-06
• Completion: 2024-11-06
• First posted: 2024-06-11
• Last updated: 2025-12-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study