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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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The purpose of this study to Assess the Abuse Potential of Intranasal Cebranopadol Compared to Oxycodone and Placebo in Healthy, Nondependent Recreational Opioid Users.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Selection- 600ug (Part A) | Experimental | Cebranopadol 600 ug single dose |
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| Dose Selection - 800 ug (Part A) | Experimental | Cebraopadol 800 ug single dose |
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| Dose Selection- 1000 ug (Part A) | Experimental | Cebranopadol 1000 ug single dose |
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| Qualification Phase - Oxycodone (Part B) | Active Comparator | Oxycodone 40mg |
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| Qualification Phase - Placebo (Part B) | Placebo Comparator | Matching Placebo |
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| Treatment Phase A- (Part B) | Experimental | -Treatment A: Cebranopadol |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cebranopadol- 600 ug | Drug | Dose ascending cohorts - Cebranopadol 600 ug single dose |
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| Measure | Description | Time Frame |
|---|---|---|
| Drug Liking VAS Emax | The primary pharmacodynamic endpoint (Drug Liking VAS Emax) will be evaluated with a linear mixed-effects model, containing treatment, period, sequence and first-order carryover as fixed effects and subject nested within sequence as random effect, using the Modified Completer Population | 48 hrs of Tmax for each treatment |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Angela Eakin, MD | Ohio Clinical Trials | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio Clinical Trials, Inc. | Columbus | Ohio | 43212 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 13, 2026 | |
| Reset | Jan 27, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 13, 2026 | Jan 27, 2026 |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000589289 | 6'-fluoro-4',9'-dihydro-N,N-dimethyl-4-phenylspiro(cyclohexane-1,1'(3'H)-pyrano(3,4-b)indol)-4-amine |
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Assessment of the Abuse Potential of Intranasal Cebranopadol Compared to Oxycodone and Placebo in Healthy, Nondependent Recreational Opioid Users
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| Treatment Phase B- (Part B) | Active Comparator | - Treatment B: Oxycodone HCl IR 40 mg |
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| Treatment Phase C (Part B) | Placebo Comparator | - Treatment C: Placebo |
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| Cebranopadol- 800ug | Drug | Dose ascending cohorts - Cebraopadol 800 ug single dose |
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| Cebranopadol- 1000ug | Drug | Dose ascending cohorts - Cebranopadol 1000 ug single dose |
|
| Treatment A: | Drug | Cebranopadol, dose determined in Part A |
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| Treatment B | Drug | Oxycodone HCl IR 40 mg |
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| Treatment C | Drug | Placebo |
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| Qualification | Drug | Oxycodone 40mg |
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| Qualification | Drug | Matching Placebo |
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