Clinical trial NCT06453265: A Study to Assess the Abuse Potential of Intranasal Cebranopadol
Official title: A Double-Blind, Randomized, Crossover Study to Assess the Abuse Potential of Intranasal Cebranopadol Compared to Oxycodone and Placebo in Healthy, Nondependent Recreational Opioid Users
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Abuse, Drug
Keywords: Human Abuse Potential
Lead sponsor: Tris Pharma, Inc.
Sponsor class: INDUSTRY
First posted: 2024-06-11
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Assessment of the Abuse Potential of Intranasal Cebranopadol Compared to Oxycodone and Placebo in Healthy, Nondependent Recreational Opioid Users
Primary purpose: TREATMENT

Brief summary: The purpose of this study to Assess the Abuse Potential of Intranasal Cebranopadol Compared to Oxycodone and Placebo in Healthy, Nondependent Recreational Opioid Users.

Detailed description: This study will be conducted to examine the intranasal abuse potential of cebranopadol compared with oxycodone HCl IR and placebo in recreational opioid users with intranasal experience, a Dose Escalation Phase (Part A) will first be conducted to determine a safe dose for evaluation in the Main Study (Part B).

The Dose Selection Phase (Part A) will consist of 3 phases: Screening, Treatment and Follow-up. Subjects will participate in an outpatient medical screening visit, a 4-day treatment visit and a follow-up phone call.

The Main Study (Part B) will consist of 4 phases: Screening, Qualification, Treatment and Follow-up. Subjects will participate in an outpatient screening visit, a 4-day Qualification Phase, a 30-day Treatment Phase and a follow-up phone call.

Eligibility criteria: Key Inclusion Criteria:

* Experienced opioid user who meets the following criteria: (1) has used opioids for nontherapeutic purposes (i.e., for psychoactive effects) on at least 10 occasions in the year prior to Screening; (2) has used opioids at least once in the 12 weeks prior to Screening; and (3) self-reported intranasal use of drugs of abuse on at least 3 occasions in the year prior to Screening.
* Subjects must be in good health as determined by medical history, physical examination, 12-lead ECG and vital signs measures (pulse rate, systolic and diastolic blood pressure, respiratory rate and oxygen saturation using pulse oximetry) at Screening.
* Subjects must be willing to comply with the requirements and restrictions of the study.

Key Exclusion Criteria:

* Drug or alcohol dependence in the 12 months prior to Screening (except nicotine), as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR), or any self-reported dependence or "addiction" within the subject's lifetime (except nicotine or caffeine).
* Subjects who have ever been in treatment for substance use disorder(s) (except smoking cessation).
* History or presence of any clinically significant cardiac, psychiatric, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, renal or other disease at Screening, which, in the opinion of the investigator, would jeopardize the safety of the subject or the validity of the study results.
* Clinically significant abnormalities in the intranasal cavity (including a deviated septum, perforated nasal septum, rhinorrhea, or excessive sneezing) or any condition that, in the opinion of the investigator, would interfere with the study procedures, data integrity or would compromise the safety of the subject. Subjects with nasal piercings/nose rings will be required to remove them for the duration of their inpatient stay.

Primary outcomes:
measure: Drug Liking VAS Emax
timeFrame: 48 hrs of Tmax for each treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio Clinical Trials, Inc.
state: Ohio
Study officials:
affiliation: Ohio Clinical Trials
name: Angela Eakin, MD
role: PRINCIPAL_INVESTIGATOR
References: