Chronic Pain study: Cebranopadol
Official title A Study of Cebranopadol for Opioid Withdrawal Symptoms in Adults With Chronic Pain
ClinicalTrials.gov ID: NCT07874620
What this study is testing
What is Cebranopadol?
Cebranopadol is an investigational oral medication being studied for chronic pain and opioid withdrawal.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether different doses of cebranopadol can reduce opioid withdrawal signs and symptoms compared with a pretend treatment.
- Who it's for
- You may be able to join if you are an adult with chronic pain who is physically dependent on prescribed opioids.
- What's involved
- You will be randomly given one of two doses of cebranopadol or a placebo. You will have visits to check your pain, safety, and how the drug behaves in your body.
- Time commitment
- The study lasts several weeks and includes multiple visits to monitor your symptoms and safety.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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
- Generally in good health and able to comply with study procedures, including opioid withdrawal and inpatient confinement.
- Meet protocol-specified reproductive and contraception requirements.
You likely can't join if
- 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...
- Positive HIV, hepatitis B surface antigen, or hepatitis C antibody test.
- Suicidal ideation or active suicidality within the past 2 years.
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- North Canton, Ohio, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at North Canton, Ohio, United States; Houston, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.