Cebranopadol for Opioid Withdrawal
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests cebranopadol to determine if it can reduce withdrawal symptoms in individuals physically dependent on prescribed opioids for chronic pain management. Participants will receive one of two doses of cebranopadol or a placebo (a substance with no active drug) through random assignment. The trial also evaluates cebranopadol's effectiveness in pain management and its safety profile. It seeks adults who have used opioids for chronic pain conditions like low back pain or osteoarthritis and are willing to stop opioid use under supervision. As a Phase 2 trial, this research measures cebranopadol's effectiveness in an initial, smaller group of participants.
Is there any evidence suggesting that cebranopadol is likely to be safe for humans?
Research has shown that cebranopadol is generally safe for use. Studies have found it less likely to cause addiction, withdrawal symptoms, physical dependence, and overdose compared to other pain medications like tramadol and oxycodone. In one study, patients used cebranopadol for 26 weeks, and it proved to be safe and well-tolerated, indicating minimal serious side effects with long-term use. Additionally, it appears to cause fewer common side effects, such as nausea and dizziness, often associated with opioid use. Overall, cebranopadol has demonstrated a good safety record in studies conducted so far.12345
Why do researchers think this study treatment might be promising for opioid withdrawal?
Researchers are excited about cebranopadol for opioid withdrawal because it targets multiple pain receptors, including both the nociceptin/orphanin FQ peptide and opioid receptors. Unlike traditional treatments such as methadone and buprenorphine, which primarily focus on opioid receptors, cebranopadol’s dual action could potentially provide more comprehensive relief from withdrawal symptoms. This unique mechanism may lead to improved efficacy and reduced cravings, offering a promising alternative for those struggling with opioid dependency.
What evidence suggests that cebranopadol might be an effective treatment for opioid withdrawal?
Research has shown that cebranopadol may help ease symptoms of opioid withdrawal. In this trial, participants will receive either 600 micrograms/day or 800 micrograms/day of cebranopadol, or a placebo. Studies have found that cebranopadol carries a lower risk of misuse and addiction compared to opioids like tramadol and oxycodone. It also reduces withdrawal symptoms in certain situations. Although high doses can cause slowed breathing, this risk is generally lower than with many traditional opioids. Additionally, cebranopadol has been noted to decrease cravings in people who misuse opioids. These findings suggest cebranopadol could be a promising option for managing opioid withdrawal symptoms.678910
Who Is on the Research Team?
Khyati Mehta
Principal Investigator
Adneuris Therapeutics
Are You a Good Fit for This Trial?
This trial is for adults with chronic pain who are physically dependent on prescribed opioid medications. Participants must have their dependence confirmed before joining.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive cebranopadol or placebo to assess withdrawal suppression over a 48-hour inpatient period
Follow-up
Participants are monitored for safety and effectiveness after treatment via a telephone call
What Are the Treatments Tested in This Trial?
Interventions
- Cebranopadol
Trial Overview
The study tests whether cebranopadol, given in different doses, can reduce opioid withdrawal symptoms compared to a placebo. Participants are randomly assigned to receive either cebranopadol or placebo.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Placebo Group
Cebranopadol 400 micrograms orally twice daily on Day 1 and 2; Final dose on the evening of Day 2.
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
Matching placebo orally twice daily on Day 1 and 2 days; Final dose on the evening of Day 2.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Adneuris Therapeutics, Inc.
Lead Sponsor
Citations
A Study of Cebranopadol for Opioid Withdrawal Symptoms ...
This Phase 2 study will evaluate whether multiple doses of cebranopadol suppress opioid withdrawal signs and symptoms compared with placebo ...
Media
Additionally, studies have shown that cebranopadol has significantly lower risks of abuse, withdrawal, physical dependence and overdose. The ...
Cebranopadol as a Novel Promising Agent for the ... - PMC - NIH
Opioids are used to treat pain, but despite their effectiveness, they possess several side effects such as respiratory depression, tolerance and physical ...
Limited potential of cebranopadol to produce...
Naloxone‐precipitated withdrawal effects on body weight in cebranopadol‐treated groups were somewhat stronger than during spontaneous withdrawal but still ...
The effect of cebranopadol, oxycodone, and placebo on ...
Painkiller drugs like cebranopadol can lead to respiratory depression (slow and shallow breathing) when taken in high doses. This is an effect that can be very ...
Tris Pharma Reports Positive Topline Data from Clinical ...
Additionally, studies have shown that cebranopadol has significantly lower risks of abuse, withdrawal, physical dependence and overdose.
Safety of tapentadol compared with other opioids in chronic ...
Outcomes assessed were overall AEs, overall serious adverse events, constipation, nausea, dizziness, somnolence, headache, and discontinuation ...
safe prescribing and withdrawal management for adults
Outcomes Intervention data: • HRQOL • Mortality • Dependence to the prescribed medicine • Withdrawal symptoms • Non-fatal overdose • Use of illicit or over the
9.
researchgate.net
researchgate.net/publication/387776563_Progress_in_pain_management_with_opioid_analgesics_focus_on_tapentadol_cebranopadol_and_oxycodone_with_naloxone(PDF) Progress in pain management with opioid analgesics
Cebranopadol showed a good safety and tolerance -related pain. Switching from morphine PR to cebranopadol was safe, well-received, and ef- fective in terms of ...
10.
clinicaltrialvanguard.com
clinicaltrialvanguard.com/news/cebranopadol-shows-low-abuse-potential-in-clinical-trial-2/Cebranopadol Shows Low Abuse Potential in Clinical Trial
Tris Pharma announced positive clinical data from its intranasal human abuse potential (HAP) study of cebranopadol.
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