Recruiting
Phase 2

Cebranopadol

Sponsor:

Adneuris Therapeutics, Inc.

Code:

NCT07874620

Conditions

Chronic Pain

Pain

Opioid Withdrawal (Disorder)

Opioid Use Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Cebranopadol

Cebranopadol

Placebo

Study Details

Brief summary:

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.

Conditions

Chronic Pain

Pain

Opioid Withdrawal (Disorder)

Opioid Use Disorder

Study ID

NCT07874620

Start date

Oct, 2026

Status verified date

Oct, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

45 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cebranopadol 600 micrograms/day

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

experimental: Cebranopadol 800 micrograms/day

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

placebo comparator: Placebo Comparator

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

Interventions

Cebranopadol

Administration orally twice daily on Days 1 and 2 and according to the assigned regimen.

Cebranopadol

Administration orally twice daily on Days 1 and 2 and according to the assigned regimen.

Placebo

Administration orally twice daily on Day 1 and 2.

Primary outcome measure

  • Clinical Opiate Withdrawal Scale (COWS) Total Score Maximum Effect (Emax) from 0 to 48 hours [ Time Frame: From first study-drug administration through 48 hours after the first dose] ]

Central Contacts and Locations

Central contacts

Study Director Adneuris Therapeutics

732-940-2800clinicaltrials@trispharma.com

Clinical Development Adneuris Therapeutics

732-940-2800clinicaltrials@trispharma.com

Locations

001127

Recruiting

North Canton, Ohio, United States, 44702

00113

Recruiting

Houston, Texas, United States, 77043

More Information

Sponsor

Adneuris Therapeutics, Inc.

Last update posted

Oct 23, 2026

Last verified

Oct, 2026

Keywords

  • cebranopadol
  • opioid withdrawal;
  • physical dependence;
  • chronic pain;
  • Clinical Opiate Withdrawal Scale
  • COWS
  • Subjective Opioid Withdrawal Scale
  • SOWS Opioid use disorder
  • Subject Opioid Withdrawal scale

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by Adneuris Therapeutics, Inc. on 2026-10-23. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.