MedDataX Logo

A Study to Assess the Abuse Potential of Intranasal Cebranopadol

NCT ID: NCT06453265

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-28

Study Completion Date

2024-11-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Abuse, Drug

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Human Abuse Potential

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Assessment of the Abuse Potential of Intranasal Cebranopadol Compared to Oxycodone and Placebo in Healthy, Nondependent Recreational Opioid Users
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Qualification Phase - Placebo (Part B)

Matching Placebo

Group Type PLACEBO_COMPARATOR

Qualification

Intervention Type DRUG

Matching Placebo

Treatment Phase A- (Part B)

-Treatment A: Cebranopadol

Group Type EXPERIMENTAL

Treatment A:

Intervention Type DRUG

Cebranopadol, dose determined in Part A

Treatment Phase B- (Part B)

\- Treatment B: Oxycodone HCl IR 40 mg

Group Type ACTIVE_COMPARATOR

Treatment B

Intervention Type DRUG

Oxycodone HCl IR 40 mg

Treatment Phase C (Part B)

\- Treatment C: Placebo

Group Type PLACEBO_COMPARATOR

Treatment C

Intervention Type DRUG

Placebo

Dose Selection- 600ug (Part A)

Cebranopadol 600 ug single dose

Group Type EXPERIMENTAL

Cebranopadol- 600 ug

Intervention Type DRUG

Dose ascending cohorts

\- Cebranopadol 600 ug single dose

Dose Selection - 800 ug (Part A)

Cebraopadol 800 ug single dose

Group Type EXPERIMENTAL

Cebranopadol- 800ug

Intervention Type DRUG

Dose ascending cohorts

\- Cebraopadol 800 ug single dose

Dose Selection- 1000 ug (Part A)

Cebranopadol 1000 ug single dose

Group Type EXPERIMENTAL

Cebranopadol- 1000ug

Intervention Type DRUG

Dose ascending cohorts

\- Cebranopadol 1000 ug single dose

Qualification Phase - Oxycodone (Part B)

Oxycodone 40mg

Group Type ACTIVE_COMPARATOR

Qualification

Intervention Type DRUG

Oxycodone 40mg

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cebranopadol- 600 ug

Dose ascending cohorts

\- Cebranopadol 600 ug single dose

Intervention Type DRUG

Cebranopadol- 800ug

Dose ascending cohorts

\- Cebraopadol 800 ug single dose

Intervention Type DRUG

Cebranopadol- 1000ug

Dose ascending cohorts

\- Cebranopadol 1000 ug single dose

Intervention Type DRUG

Treatment A:

Cebranopadol, dose determined in Part A

Intervention Type DRUG

Treatment B

Oxycodone HCl IR 40 mg

Intervention Type DRUG

Treatment C

Placebo

Intervention Type DRUG

Qualification

Oxycodone 40mg

Intervention Type DRUG

Qualification

Matching Placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Tris Pharma, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Angela Eakin, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio Clinical Trials

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ohio Clinical Trials, Inc.

Columbus, Ohio, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TRN-228-102

Identifier Type: -

Identifier Source: org_study_id