Intranasal Cebranopadol for Substance Abuse

Overseen By Liza Micioni

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Tris Pharma, Inc.

Disqualifiers: Drug dependence, Cardiac disease, Psychiatric, others

Compensation: Varies

Number of Visits: Unknown

Duration: 30 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how intranasal cebranopadol, a potential new treatment, compares to oxycodone and a placebo regarding misuse potential. Researchers focus on understanding the effects of cebranopadol when used recreationally by individuals familiar with opioids. Ideal participants are healthy individuals who have used opioids recreationally at least ten times in the past year and have tried nasal drugs at least three times in that period. As a Phase 1 trial, this research seeks to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that cebranopadol is much less likely to be misused when snorted compared to oxycodone, indicating a positive safety profile among recreational opioid users. The study primarily examined cebranopadol's nasal administration. Although specific side effects are not detailed, conducting a study implies some confidence in its basic safety for humans.

As this is a Phase 1 trial, the primary goal is to assess the treatment's safety and tolerability. These trials typically begin with healthy volunteers. If cebranopadol had already received FDA approval for another use, it would further suggest its safety. Current knowledge indicates that cebranopadol is well-tolerated and poses a lower risk of misuse compared to oxycodone. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about Cebranopadol for substance abuse because it offers a novel approach compared to traditional treatments like methadone and buprenorphine. Unlike these standard options, Cebranopadol is administered intranasally, potentially offering a quicker onset of action and ease of use. Additionally, it has a unique mechanism, acting as a nociceptin/orphanin FQ peptide receptor agonist, which may provide an innovative pathway to manage cravings and withdrawal symptoms. This new approach could offer a more effective and targeted treatment for individuals struggling with substance abuse.

What evidence suggests that this trial's treatments could be effective for substance abuse?

Research has shown that cebranopadol, which participants in this trial may receive, might be less likely to be misused compared to drugs like oxycodone. Specifically, studies found that when taken nasally, cebranopadol is less prone to abuse. It also helps reduce the desire to take opioids and can prevent relapse triggered by stress, potentially supporting those trying to quit opioid use. By relieving pain and reducing cravings, cebranopadol might offer a safer option for managing substance abuse. ^{1 2 6 7 8}

Who Is on the Research Team?

Angela Eakin, MD

Principal Investigator

Ohio Clinical Trials

Are You a Good Fit for This Trial?

This trial is for healthy adults who occasionally use opioids recreationally but aren't dependent on them. Participants should not have any significant health issues and must pass a drug screening test.

Inclusion Criteria

I am in good health based on recent medical exams and tests.

Subjects must be willing to comply with the requirements and restrictions of the study

Experienced opioid user meeting specific criteria: (1) used opioids for nontherapeutic purposes on at least 10 occasions in the year prior to Screening, (2) 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

Exclusion Criteria

I don't have any health conditions that could risk my safety or affect the study's results.

Drug or alcohol dependence in the 12 months prior to Screening (except nicotine) as defined by 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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Outpatient visit

Qualification

Participants undergo a 4-day qualification phase to assess suitability for the main study

4 days

Treatment

Participants receive treatment with either cebranopadol, oxycodone, or placebo over a 30-day period

30 days

Follow-up

Participants are monitored for safety and effectiveness after treatment via a follow-up phone call

What Are the Treatments Tested in This Trial?

Interventions

• Cebranopadol

Trial Overview

The study is testing the potential for abuse of Cebranopadol when taken through the nose, comparing three different doses (600ug, 800ug, and 1000ug) to Oxycodone and a placebo.

How Is the Trial Designed?

Group I: Treatment Phase A- (Part B) Experimental Treatment 1 Intervention

-Treatment A: Cebranopadol

Group II: Dose Selection- 600ug (Part A) Experimental Treatment 1 Intervention

Cebranopadol 600 ug single dose

Group III: Dose Selection- 1000 ug (Part A) Experimental Treatment 1 Intervention

Cebranopadol 1000 ug single dose

Group IV: Dose Selection - 800 ug (Part A) Experimental Treatment 1 Intervention

Cebraopadol 800 ug single dose

Group V: Qualification Phase - Oxycodone (Part B) Active Control 1 Intervention

Oxycodone 40mg

Group VI: Treatment Phase B- (Part B) Active Control 1 Intervention

\- Treatment B: Oxycodone HCl IR 40 mg

Group VII: Qualification Phase - Placebo (Part B) Placebo Group 1 Intervention

Matching Placebo

Group VIII: Treatment Phase C (Part B) Placebo Group 1 Intervention

\- Treatment C: Placebo

Who Is Running the Clinical Trial?

Tris Pharma, Inc.

Lead Sponsor

Trials

22

Recruited

4,800+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Citations

1.

trispharma.com

trispharma.com/tris-pharma-presents-data-reinforcing-limited-abuse-potential-of-investigational-pain-therapy-cebranopadol-at-the-2023-painweek-conference/

Media

Positive results confirm findings from prior studies evaluating the abuse potential of cebranopadol, further highlighting its potential as a ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6319565/

Assessment of the Abuse Potential of Cebranopadol in ...

Based on nonclinical data, we hypothesized that this novel mechanism of action may lead to a lower risk of abuse compared with pure MOP receptor agonists such ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06453265

A Study to Assess the Abuse Potential of Intranasal ...

This study will be conducted to examine the intranasal abuse potential of cebranopadol compared with oxycodone HCl IR and placebo in recreational opioid users ...

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S002839082400217X

Cebranopadol, a novel long-acting opioid agonist with low ...

Cebranopadol is highly efficacious in attenuating opioid self-administration and stress-induced reinstatement, while having limited abuse liability properties.

5.

trispharma.com

trispharma.com/tris-pharma-reports-positive-clinical-results-of-intranasal-human-abuse-potential-study-indicating-low-abusability-of-cebranopadol-an-investigational-first-in-class-oral-dual-nmr-agonist-for-the-tre/

Media

Study met primary endpoint demonstrating cebranopadol is significantly less abusable than oxycodone when taken intranasally (ie, snorted)

6.

trispharma.com

trispharma.com/tris-pharma-debut-intranasal-results-cpdd-2025/

Media

Study met primary endpoint demonstrating cebranopadol is significantly less likely to be misused intranasally (snorting) than oxycodone with ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06453265?term=CEBRANOPADOL&viewType=Table&rank=10

A Study to Assess the Abuse Potential of Intranasal Cebranopadol

A phase of research to describe clinical trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the goal is to ...

8.

drugtopics.com

drugtopics.com/view/new-data-shows-cebranopadol-s-potential-in-acute-pain-management

New Data Shows Cebranopadol's Potential in Acute Pain ...

3. Tris Pharma Reports Positive Clinical Results of Intranasal Human Abuse Potential Study Indicating Low Abusability of Cebranopadol, an ...