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Opioid

Intranasal Cebranopadol for Substance Abuse

Phase 1
Waitlist Available
Led By Angela Eakin, MD
Research Sponsored by Tris Pharma, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Must not have
History or presence of any clinically significant disease at Screening that would jeopardize the safety of the subject or the validity of the study results
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 hrs of tmax for each treatment

Summary

"This trial is aiming to see if using Cebranopadol through the nose can be addictive for people who aren't addicted to opioids, compared to using Oxycodone and a fake treatment."

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects may include typical opioid-related reactions such as nausea, dizziness, sleepiness, headache, or euphoria. The risk of addiction or misuse will also be evaluated.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I don't have any health conditions that could risk my safety or affect the study's results.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 hrs of tmax for each treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 hrs of tmax for each treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Drug Liking VAS Emax

Trial Design

8Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Treatment Phase A- (Part B)Experimental Treatment1 Intervention
-Treatment A: Cebranopadol
Group II: Dose Selection- 600ug (Part A)Experimental Treatment1 Intervention
Cebranopadol 600 ug single dose
Group III: Dose Selection- 1000 ug (Part A)Experimental Treatment1 Intervention
Cebranopadol 1000 ug single dose
Group IV: Dose Selection - 800 ug (Part A)Experimental Treatment1 Intervention
Cebraopadol 800 ug single dose
Group V: Qualification Phase - Oxycodone (Part B)Active Control1 Intervention
Oxycodone 40mg
Group VI: Treatment Phase B- (Part B)Active Control1 Intervention
- Treatment B: Oxycodone HCl IR 40 mg
Group VII: Qualification Phase - Placebo (Part B)Placebo Group1 Intervention
Matching Placebo
Group VIII: Treatment Phase C (Part B)Placebo Group1 Intervention
- Treatment C: Placebo

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Tris Pharma, Inc.Lead Sponsor
21 Previous Clinical Trials
4,768 Total Patients Enrolled
Angela Eakin, MDPrincipal InvestigatorOhio Clinical Trials
1 Previous Clinical Trials
40 Total Patients Enrolled
~0 spots leftby Dec 2024
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