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

45 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Research Team

Angela Eakin, MD

Principal Investigator

Ohio Clinical Trials

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+