45 Participants NeededMy employer runs this trial

Cebranopadol for Opioid Withdrawal

Recruiting at 1 trial location
SD
CD
Overseen ByClinical Development Adneuris Therapeutics
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Adneuris Therapeutics, Inc.
Must be taking: Opioids
Prior Safety DataThis treatment has passed at least one previous human trial

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?

KM

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

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
See 4 more

Exclusion Criteria

Clinically significant medical or psychiatric condition that could compromise participant safety or study validity
Positive HIV, hepatitis B surface antigen, or hepatitis C antibody test
I do not have any excluded pain, nerve, spine, infection, or tumor-related conditions.
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
Outpatient screening

Treatment

Participants receive cebranopadol or placebo to assess withdrawal suppression over a 48-hour inpatient period

2 days
Inpatient stay

Follow-up

Participants are monitored for safety and effectiveness after treatment via a telephone call

7 days
1 follow-up 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

Group I: Cebranopadol 800 micrograms/dayExperimental Treatment1 Intervention
Group II: Cebranopadol 600 micrograms/dayExperimental Treatment1 Intervention
Group III: Placebo ComparatorPlacebo Group1 Intervention

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

(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 ...

Cebranopadol Shows Low Abuse Potential in Clinical Trial

Tris Pharma announced positive clinical data from its intranasal human abuse potential (HAP) study of cebranopadol.