A Study to Assess the Abuse Potential of Intranasal Cebranopadol

Tris Pharma

Status and phase: Completed; Phase 1

Conditions: Abuse, Drug

Treatments: Drug: Treatment C; Drug: Qualification; Drug: Treatment A:; Drug: Cebranopadol- 600 ug; Drug: Cebranopadol- 1000ug; Drug: Cebranopadol- 800ug; Drug: Treatment B

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT06453265

TRN-228-102

Details and patient eligibility

About

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

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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48 participants in 8 patient groups, including a placebo group

Dose Selection- 600ug (Part A)

Experimental group

Description:

Cebranopadol 600 ug single dose

Treatment:

Drug: Cebranopadol- 600 ug

Dose Selection - 800 ug (Part A)

Experimental group

Description:

Cebraopadol 800 ug single dose

Treatment:

Drug: Cebranopadol- 800ug

Dose Selection- 1000 ug (Part A)

Experimental group

Description:

Cebranopadol 1000 ug single dose

Treatment:

Drug: Cebranopadol- 1000ug

Qualification Phase - Oxycodone (Part B)

Active Comparator group

Description:

Oxycodone 40mg

Treatment:

Drug: Qualification

Drug: Qualification

Qualification Phase - Placebo (Part B)

Placebo Comparator group

Description:

Matching Placebo

Treatment:

Drug: Qualification

Drug: Qualification

Treatment Phase A- (Part B)

Experimental group

Description:

-Treatment A: Cebranopadol

Treatment:

Drug: Treatment A:

Treatment Phase B- (Part B)

Active Comparator group

Description:

\- Treatment B: Oxycodone HCl IR 40 mg

Treatment:

Drug: Treatment B

Treatment Phase C (Part B)

Placebo Comparator group

Description:

\- Treatment C: Placebo

Treatment:

Drug: Treatment C