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A Study to Assess the Abuse Potential of Intranasal Cebranopadol

NCT06453265 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-12-18

No results posted yet for this study

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.

Conditions

  • Abuse, Drug

Interventions

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

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Tris Pharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Angela Eakin, MD · Ohio Clinical Trials

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-28
Primary Completion
2024-11-06
Completion
2024-11-06
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06453265 on ClinicalTrials.gov