NCT07874620 A Study of Cebranopadol for Opioid Withdrawal Symptoms in Adults With Chronic Pain
| NCT ID | NCT07874620 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Adneuris Therapeutics, Inc. |
| Condition | Chronic Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2026-10 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 45 participants in total. It began in 2026-10 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Khyati Mehta
STUDY DIRECTOR
Adneuris Therapeutics
Frequently Asked Questions
Who can join the NCT07874620 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Chronic Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07874620 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07874620 currently recruiting?
Yes, NCT07874620 is actively recruiting participants. Contact the research team at clinicaltrials@trispharma.com for enrollment information.
Where is the NCT07874620 trial being conducted?
This trial is being conducted at North Canton, United States, Houston, United States.
Who is sponsoring the NCT07874620 clinical trial?
NCT07874620 is sponsored by Adneuris Therapeutics, Inc.. The principal investigator is Khyati Mehta at Adneuris Therapeutics. The trial plans to enroll 45 participants.
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