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Taking people in United StatesPhase 2

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

Key facts

Who runs it
Adneuris Therapeutics, Inc.
Where
Houston and North Canton, United StatesSee the 2 sites
Trial code
Status
Recruiting
Phase
Phase 2
People taking part
45 people, planned
Started
Oct 2026
Expected to end
Jun 2027
Type of study
Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Cebranopadol
  • Placebo
Record updated
23 October 2026

Who can take part

Age
18 years to 65 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 18 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • 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
  • 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
  • QTcF >450 ms in males or >470 ms in females, other torsade de pointes risk factors, or use of QT-prolonging medications
  • Suicidal ideation or active suicidality within the past 2 years
  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 65 years old?

Where in United States

  • 00113Houston, United StatesContact: Study Director Adneuris TherapeuticsTaking people
  • 001127North Canton, United StatesContact: Study Director Adneuris TherapeuticsTaking people

About the trial

What the trial wants to find out

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.

The 3 groups in the trial

  • Cebranopadol 600 micrograms/dayTreatment being tested

    Cebranopadol 400 micrograms orally in the morning and 200 micrograms orally in the evening on Day 1 and 2; final dose on the evening of Day 2

    Treatment: Cebranopadol

  • Cebranopadol 800 micrograms/dayTreatment being tested

    Cebranopadol 400 micrograms orally twice daily on Day 1 and 2; Final dose on the evening of Day 2.

    Treatment: Cebranopadol

  • Placebo ComparatorPlacebo, for comparison

    Matching placebo orally twice daily on Day 1 and 2 days; Final dose on the evening of Day 2.

    Treatment: Placebo

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Randomized, Double-Blind, Multiple-Dose Study to Assess the Ability of Cebranopadol to Suppress Withdrawal Signs and Symptoms in Adults With Chronic Pain Who Are Physically Dependent on Opioids
Fit questions
Built from NCT07874620, who can take part
Record updated
23 October 2026