A Study to Assess the Abuse Potential of Intranasal Cebranopadol

NCT06453265 | Completed Phase 1 FDA Drug

• 1 other identifier: TRN-228-102
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Human Abuse Potential

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (8)

Dose Selection- 600ug (Part A)

EXPERIMENTAL

Cebranopadol 600 ug single dose

Drug: Cebranopadol- 600 ug

Dose Selection - 800 ug (Part A)

EXPERIMENTAL

Cebraopadol 800 ug single dose

Drug: Cebranopadol- 800ug

Dose Selection- 1000 ug (Part A)

EXPERIMENTAL

Cebranopadol 1000 ug single dose

Drug: Cebranopadol- 1000ug

Qualification Phase - Oxycodone (Part B)

ACTIVE COMPARATOR

Oxycodone 40mg

Drug: Qualification

Qualification Phase - Placebo (Part B)

PLACEBO COMPARATOR

Matching Placebo

Drug: Qualification

Treatment Phase A- (Part B)

EXPERIMENTAL

-Treatment A: Cebranopadol

Drug: Treatment A:

Treatment Phase B- (Part B)

ACTIVE COMPARATOR

\- Treatment B: Oxycodone HCl IR 40 mg

Drug: Treatment B

Treatment Phase C (Part B)

PLACEBO COMPARATOR

\- Treatment C: Placebo

Drug: Treatment C

Interventions

Treatment C DRUG

Placebo

Treatment Phase C (Part B)

Qualification DRUG

Oxycodone 40mg

Qualification Phase - Oxycodone (Part B)

Cebranopadol- 600 ug DRUG

Dose ascending cohorts \- Cebranopadol 600 ug single dose

Dose Selection- 600ug (Part A)

Cebranopadol- 800ug DRUG

Dose ascending cohorts \- Cebraopadol 800 ug single dose

Dose Selection - 800 ug (Part A)

Cebranopadol- 1000ug DRUG

Dose ascending cohorts \- Cebranopadol 1000 ug single dose

Dose Selection- 1000 ug (Part A)

Treatment A: DRUG

Cebranopadol, dose determined in Part A

Treatment Phase A- (Part B)

Treatment B DRUG

Oxycodone HCl IR 40 mg

Treatment Phase B- (Part B)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tris Pharma, Inc.: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Ohio Clinical Trials, Inc.

Columbus, Ohio, 43212, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

6'-fluoro-4',9'-dihydro-N,N-dimethyl-4-phenylspiro(cyclohexane-1,1'(3'H)-pyrano(3,4-b)indol)-4-amine

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Angela Eakin, MD

  Ohio Clinical Trials

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Assessment of the Abuse Potential of Intranasal Cebranopadol Compared to Oxycodone and Placebo in Healthy, Nondependent Recreational Opioid Users

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 11, 2024
• Study Start: June 28, 2024
• Primary Completion: November 6, 2024
• Study Completion: November 6, 2024
• Last Updated: December 18, 2025

Record last verified: 2025-09

Locations

US (1)