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

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

Study Overview

• Status: Completed
• Conditions: Abuse, Drug
• Intervention / Treatment: Drug: Cebranopadol- 600 ug; Drug: Cebranopadol- 800ug; Drug: Cebranopadol- 1000ug; Drug: Qualification; Drug: Qualification; Drug: Treatment A:; Drug: Treatment B; Drug: Treatment C

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.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43212
      • Ohio Clinical Trials, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Key Inclusion Criteria:

• Experienced opioid user who meets the following criteria: (1) has used opioids for nontherapeutic purposes (i.e., for psychoactive effects) on at least 10 occasions in the year prior to Screening; (2) has used opioids at least once in the 12 weeks prior to Screening; and (3) self-reported intranasal use of drugs of abuse on at least 3 occasions in the year prior to Screening.
• Subjects must be in good health as determined by medical history, physical examination, 12-lead ECG and vital signs measures (pulse rate, systolic and diastolic blood pressure, respiratory rate and oxygen saturation using pulse oximetry) at Screening.
• Subjects must be willing to comply with the requirements and restrictions of the study.

Key Exclusion Criteria:

• Drug or alcohol dependence in the 12 months prior to Screening (except nicotine), as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR), or any self-reported dependence or "addiction" within the subject's lifetime (except nicotine or caffeine).
• Subjects who have ever been in treatment for substance use disorder(s) (except smoking cessation).
• History or presence of any clinically significant cardiac, psychiatric, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, renal or other disease at Screening, which, in the opinion of the investigator, would jeopardize the safety of the subject or the validity of the study results.
• Clinically significant abnormalities in the intranasal cavity (including a deviated septum, perforated nasal septum, rhinorrhea, or excessive sneezing) or any condition that, in the opinion of the investigator, would interfere with the study procedures, data integrity or would compromise the safety of the subject. Subjects with nasal piercings/nose rings will be required to remove them for the duration of their inpatient stay.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose Selection- 600ug (Part A); Cebranopadol 600 ug single dose	Drug: Cebranopadol- 600 ug; Dose ascending cohorts - Cebranopadol 600 ug single dose
Experimental: Dose Selection - 800 ug (Part A); Cebraopadol 800 ug single dose	Drug: Cebranopadol- 800ug; Dose ascending cohorts - Cebraopadol 800 ug single dose
Experimental: Dose Selection- 1000 ug (Part A); Cebranopadol 1000 ug single dose	Drug: Cebranopadol- 1000ug; Dose ascending cohorts - Cebranopadol 1000 ug single dose
Active Comparator: Qualification Phase - Oxycodone (Part B); Oxycodone 40mg	Drug: Qualification; Oxycodone 40mg; Drug: Qualification; Matching Placebo
Placebo Comparator: Qualification Phase - Placebo (Part B); Matching Placebo	Drug: Qualification; Oxycodone 40mg; Drug: Qualification; Matching Placebo
Experimental: Treatment Phase A- (Part B); -Treatment A: Cebranopadol	Drug: Treatment A: Cebranopadol, dose determined in Part A
Active Comparator: Treatment Phase B- (Part B); - Treatment B: Oxycodone HCl IR 40 mg	Drug: Treatment B; Oxycodone HCl IR 40 mg
Placebo Comparator: Treatment Phase C (Part B); - Treatment C: Placebo	Drug: Treatment C; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drug Liking VAS Emax	The primary pharmacodynamic endpoint (Drug Liking VAS Emax) will be evaluated with a linear mixed-effects model, containing treatment, period, sequence and first-order carryover as fixed effects and subject nested within sequence as random effect, using the Modified Completer Population	48 hrs of Tmax for each treatment

Collaborators and Investigators

• Sponsor: Tris Pharma, Inc.
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Angela Eakin, MD, Ohio Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2024
• Primary Completion (Actual): November 6, 2024
• Study Completion (Actual): November 6, 2024

Study Registration Dates

• First Submitted: June 5, 2024
• First Submitted That Met QC Criteria: June 10, 2024
• First Posted (Actual): June 11, 2024

Study Record Updates

• Last Update Posted (Actual): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Human Abuse Potential
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; 6'-fluoro-4',9'-dihydro-N,N-dimethyl-4-phenylspiro(cyclohexane-1,1'(3'H)-pyrano(3,4-b)indol)-4-amine
• Other Study ID Numbers: TRN-228-102

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No