Abuse, DrugPhase 1NCT06453265
A Study to Assess the Abuse Potential of Intranasal Cebranopadol
A Phase 1 study testing Cebranopadol- 600 ug, Cebranopadol- 800ug and Cebranopadol- 1000ug in people with Abuse, Drug, run by Tris Pharma, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Abuse, Drug
- What is being tested?
- Cebranopadol- 600 ug, Cebranopadol- 800ug and Cebranopadol- 1000ug
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2024to 6 Nov 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Cebranopadol- 600 ug, Cebranopadol- 800ug, Cebranopadol- 1000ug, Treatment A:, Treatment B
- Keywords
- Human Abuse Potential
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cebranopadol- 600 ugDrug
Dose ascending cohorts
- Cebranopadol 600 ug single dose
Cebranopadol- 800ugDrug
Dose ascending cohorts
- Cebraopadol 800 ug single dose
Cebranopadol- 1000ugDrug
Dose ascending cohorts
- Cebranopadol 1000 ug single dose
Treatment A:Drug
Cebranopadol, dose determined in Part A
Treatment BDrug
Oxycodone HCl IR 40 mg
Treatment CDrug
Placebo
QualificationDrug
Oxycodone 40mg
QualificationDrug
Matching Placebo
| Study group | Role | What they receive |
|---|---|---|
| Dose Selection- 600ug (Part A) | Experimental | Cebranopadol 600 ug single dose Receives: Drug: Cebranopadol- 600 ug |
| Dose Selection - 800 ug (Part A) | Experimental | Cebraopadol 800 ug single dose Receives: Drug: Cebranopadol- 800ug |
| Dose Selection- 1000 ug (Part A) | Experimental | Cebranopadol 1000 ug single dose Receives: Drug: Cebranopadol- 1000ug |
| Qualification Phase - Oxycodone (Part B) | Active comparator | Oxycodone 40mg Receives: Drug: Qualification |
| Qualification Phase - Placebo (Part B) | Placebo comparator | Matching Placebo Receives: Drug: Qualification |
| Treatment Phase A- (Part B) | Experimental | -Treatment A: Cebranopadol Receives: Drug: Treatment A: |
| Treatment Phase B- (Part B) | Active comparator | - Treatment B: Oxycodone HCl IR 40 mg Receives: Drug: Treatment B |
| Treatment Phase C (Part B) | Placebo comparator | - Treatment C: Placebo Receives: Drug: Treatment C |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 48 hrs of Tmax for each treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start28 Jun 2024
- Primary completion6 Nov 2024
- Study completion6 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abuse, DrugStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Assessment of the Abuse Potential of Intranasal Cebranopadol Compared to Oxycodone and Placebo in Healthy, Nondependent Recreational Opioid Users
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tris Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Angela Eakin, MD, Principal investigator, Ohio Clinical Trials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06453265
- Sponsor's protocol ID
- TRN-228-102
- Status last verified
- Sep 2025
- First submitted
- 5 Jun 2024
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06453265
- Acronym / sponsor ID
- TRN-228-102
- Conditions
- Abuse, Drug
- Keywords
- Human Abuse Potential
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Tris Pharma, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 28 Jun 2024 (actual)
- Primary completion
- 6 Nov 2024 (actual)
- Study completion
- 6 Nov 2024 (actual)
- First posted
- 11 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
- Model description
- Assessment of the Abuse Potential of Intranasal Cebranopadol Compared to Oxycodone and Placebo in Healthy, Nondependent Recreational Opioid Users
| Arm | Type | Receives |
|---|---|---|
| Dose Selection- 600ug (Part A) | Experimental | Drug: Cebranopadol- 600 ugCebranopadol 600 ug single dose |
| Dose Selection - 800 ug (Part A) | Experimental | Drug: Cebranopadol- 800ugCebraopadol 800 ug single dose |
| Dose Selection- 1000 ug (Part A) | Experimental | Drug: Cebranopadol- 1000ugCebranopadol 1000 ug single dose |
| Qualification Phase - Oxycodone (Part B) | Active comparator | Drug: QualificationOxycodone 40mg |
| Qualification Phase - Placebo (Part B) | Placebo comparator | Drug: QualificationMatching Placebo |
| Treatment Phase A- (Part B) | Experimental | Drug: Treatment A:-Treatment A: Cebranopadol |
| Treatment Phase B- (Part B) | Active comparator | Drug: Treatment B- Treatment B: Oxycodone HCl IR 40 mg |
| Treatment Phase C (Part B) | Placebo comparator | Drug: Treatment C- Treatment C: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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 (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cebranopadol- 600 ugDose ascending cohorts - Cebranopadol 600 ug single dose | Drug | Dose Selection- 600ug (Part A) |
| Cebranopadol- 800ugDose ascending cohorts - Cebraopadol 800 ug single dose | Drug | Dose Selection - 800 ug (Part A) |
| Cebranopadol- 1000ugDose ascending cohorts - Cebranopadol 1000 ug single dose | Drug | Dose Selection- 1000 ug (Part A) |
| Treatment A:Cebranopadol, dose determined in Part A | Drug | Treatment Phase A- (Part B) |
| Treatment BOxycodone HCl IR 40 mg | Drug | Treatment Phase B- (Part B) |
| Treatment CPlacebo | Drug | Treatment Phase C (Part B) |
| QualificationOxycodone 40mg | Drug | Qualification Phase - Oxycodone (Part B) |
| QualificationMatching Placebo | Drug | Qualification Phase - Placebo (Part B) |
Primary outcome
Drug Liking VAS Emax
Time frame: 48 hrs of Tmax for each treatment
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
Related trials for Abuse, Drug
Recruiting
The Trans-Led Care Study
Substance Abuse, Substance Addiction
Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence
Recruiting
Advanced Functional and Structural MRI Techniques for Neuropharmacological Imaging
Drug Abuse, Nicotine Dependence
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Active, not recruiting
The MOUD Plus Pilot: Counseling and Peer Support to Support Retention for Medically Complex Patients With Opioid Use Disorder Seen In Primary Care
Opioid Dependence, Substance Abuse Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angela Eakin, MD principal investigator
Ohio Clinical Trials
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cebranopadol- 600 ug, Cebranopadol- 800ug and Cebranopadol- 1000ug in people with Abuse, Drug, run by Tris Pharma, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drug Liking VAS Emax (time frame: 48 hrs of Tmax for each treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.