Finding studies
Finding studies
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Study Director Adneuris Therapeutics
CONTACT
Clinical Development Adneuris Therapeutics
CONTACT
Lead
Adneuris Therapeutics, Inc.
Participants will complete outpatient screening followed by an inpatient treatment period and a safety follow-up telephone call. Within 30 days of initiating screening, participants will be admitted to the clinical research site. Their current prescribed opioid will be withheld after the scheduled morning dose on Day -1, and withdrawal signs and symptoms will be assessed using the Clinical Opiate Withdrawal Scale (COWS) and Subjective Opioid Withdrawal Scale (SOWS) to confirm physical dependence. Participants meeting the predefined withdrawal criteria will resume their prescribed opioid as specified in the protocol and will subsequently be randomized on Day 1. Eligible participants will be randomized 1:1:1, stratified by current prescribed daily opioid regimen (50-75 morphine milligram equivalents \[MME\] versus \>=76 MME), to cebranopadol 400 micrograms in the morning plus 200 micrograms in the evening, cebranopadol 400 micrograms twice daily, or matching placebo twice daily. Study drug is administered every 12 hours for 48 hours. Participants remain inpatient during treatment and undergo withdrawal, pain, safety, and pharmacokinetic assessments. Rescue medication is available according to protocol-defined criteria. Participants may resume their current prescribed opioid at least 12 hours after the final study-drug dose and are monitored until discharge on Day 4. A safety follow-up telephone call occurs on Day 7 (+/-2 days) after the last study-drug administration
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted