A Study of Cebranopadol for Opioid Withdrawal Symptoms in Adults With Chronic Pain
Condition(s) studied
Investigational drug(s) / intervention(s)
Cebranopadol: Administration orally twice daily on Days 1 and 2 and according to the assigned regimen.
Cebranopadol: Administration orally twice daily on Days 1 and 2 and according to the assigned regimen.
Placebo: Administration orally twice daily on Day 1 and 2.
Study summary
This Phase 2 study will evaluate whether multiple doses of cebranopadol suppress opioid withdrawal signs and symptoms compared with placebo in adults with chronic pain who are physically dependent on prescribed opioids. Participants whose physical dependence is confirmed will be assigned by chance to one of two cebranopadol dose regimens or matching placebo. The study will also evaluate pain, safety and tolerability, and cebranopadol pharmacokinetics.
Eligibility
Primary outcome measure(s)
- Clinical Opiate Withdrawal Scale (COWS) Total Score Maximum Effect (Emax) from 0 to 48 hours — From first study-drug administration through 48 hours after the first dose]
Maximum (peak) COWS total score observed during the 48-hour assessment period. after the first study drug dose, using the protocol-specified adjustment for rescue medication. The COWS is an 11-item clinician-rated scale used to assess opioid withdrawal signs and symptoms. Total scores range from 0 to 48, with higher scores indicating greater withdrawal severity.
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| 001127 | North Canton | Ohio | |
| 00113 | Houston | Texas |
More Adneuris Therapeutics, Inc. trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07874620 on ClinicalTrials.gov ↗ ← All trials in the USA