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Starting soon Phase 2

A Study of Cebranopadol for Opioid Withdrawal Symptoms in Adults With Chronic Pain

NCT07874620 · tracked via the Priya Life Science USA tracker
Sponsor
Adneuris Therapeutics, Inc
Phase
Phase 2
Started
2026-09
Last updated
2026-10-19

Condition(s) studied

Chronic PainPainOpioid Withdrawal (Disorder)Opioid Use Disorder

Investigational drug(s) / intervention(s)

Cebranopadol →Cebranopadol →Placebo

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

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Key Inclusion Criteria: * Adults 18-65 years with BMI 18.0-40.0 kg/m² and weight ≥50 kg. * Chronic daily pain for ≥6 months due to chronic low back pain, hip/knee osteoarthritis, or painful peripheral neuropathy. * Prescribed opioid use ≥5 days/week for ≥3 months within the prior 6 months, generally 50-90 MME/day; \>90 MME/day may be allowed with Sponsor/designee approval. * Generally in good health and able to comply with study procedures, including opioid withdrawal and inpatient confinement. * Meet protocol-specified reproductive and contraception requirements. * Able to provide informed consent and complete study assessments in English. * Physical opioid dependence confirmed by protocol-defined COWS and/or SOWS criteria before randomization. Key Exclusion Criteria: * Clinically significant medical or psychiatric condition that could compromise participant safety or study validity. * Protocol-specified excluded pain, neurologic, spinal, infectious, or neoplasm-related conditions. * QTcF \>450 ms in males or \>470 ms in females, other torsade de pointes risk factors, or use of QT-prolonging medications. * Substance use disorder other than opioid, nicotine, or caffeine use disorder, or positive testing for prohibited drugs/alcohol, subject to the protocol-specified cannabinoid exception. * Positive HIV, hepatitis B surface antigen, or hepatitis C antibody test. * Suicidal ideation or active suicidality within the past 2 years. * Use of prohibited medications or inability to meet protocol-specified medication washout requirements. * Pregnant or breastfeeding or planning pregnancy within 30 days after the last study-drug dose. * Significant adverse reaction to naloxone or related opioids/opioid antagonists. * Unable to undergo IV catheter placement or otherwise considered unsuitable or unlikely to comply with the protocol. * Legal, employment, or other circumstances that could interfere with study participation or compliance.

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)

FacilityCityRegionStatus
001127 North Canton Ohio
00113 Houston Texas
Official registry record

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