Cebranopadol for opioid withdrawal in adults with chronic pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this Phase 2, adults with chronic pain and ongoing opioid use will be screened and then admitted for an inpatient treatment period. After confirming physical dependence, participants are randomized to one of three regimens: cebranopadol in the morning plus evening, cebranopadol twice daily, or placebo, for 48 hours. Outcomes include withdrawal signs and symptoms, pain control, safety, tolerability, and drug pharmacokinetics, with recovery monitored through Day 4 and a safety follow-up call around Day 7. Stratification at randomization accounts for different daily opioid doses (50-75 MME versus ≥76 MME). Rescue medications are available as needed.

Why it matters

Who can join: the full rules

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.

Where it's running

• 001127
  North Canton, Ohio, United States Recruiting
• 00113
  Houston, Texas, United States Recruiting

Study contacts

• Study coordinator: Study Director Adneuris Therapeutics
• Email: clinicaltrials@trispharma.com
• Phone: 732-940-2800

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.