A Phase 1 interventional study of Cebranopadol- 600 ug and Cebranopadol- 800ug in Abuse, Drug, sponsored by Tris Pharma, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-18.
Sponsored by Tris Pharma, Inc. · Phase 1, Interventional, and Treatment
The purpose of this study to Assess the Abuse Potential of Intranasal Cebranopadol Compared to Oxycodone and Placebo in Healthy, Nondependent Recreational Opioid Users.
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.
2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.
This study's enrollment of 48 is below the median of 108 across 1,727 interventional studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →Tris Pharma, Inc. is the lead sponsor of 22 studies on the registry; none are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 4 (31%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Cebranopadol 600 ug single dose
Drug: Cebranopadol- 600 ug
Cebraopadol 800 ug single dose
Drug: Cebranopadol- 800ug
Cebranopadol 1000 ug single dose
Drug: Cebranopadol- 1000ug
Oxycodone 40mg
Drug: Qualification
Matching Placebo
Drug: Qualification
-Treatment A: Cebranopadol
Drug: Treatment A:
\- Treatment B: Oxycodone HCl IR 40 mg
Drug: Treatment B
\- Treatment C: Placebo
Drug: Treatment C
Dose ascending cohorts \- Cebranopadol 600 ug single dose
Dose ascending cohorts \- Cebraopadol 800 ug single dose
Dose ascending cohorts \- Cebranopadol 1000 ug single dose
Cebranopadol, dose determined in Part A
Oxycodone HCl IR 40 mg
Placebo
Oxycodone 40mg
Matching Placebo
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
Time frame: 48 hrs of Tmax for each treatment
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Tris Pharma, Inc.