NCT05256108

Assessment of Abuse Potential of Cebranopadol in Humans

A Single-dose, Randomized, Double-blind, Placebo- and Active-controlled Crossover Trial to Evaluate the Abuse Potential of Two Doses of Cebranopadol in Adult Nondependent Recreational Opioid Users

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Tris Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study will be conducted to evaluate the abuse potential of single doses of cebranopadol as compared with oxycodone, tramadol and matching placebo in recreational drug users.

Detailed description

Randomized, single site, double-blind, placebo- and active-controlled, crossover, single oral dose, Phase 1 trial, in non dependent recreational opioid users

Conditions

• Human Abuse Potential

Interventions

Type	Name	Description
DRUG	Oxycodone 40 mg	Participants will be administered a single dose of 6 capsules containing oxycodone and placebo in a randomized crossover manner
DRUG	Tramadol 600 mg	Participants will be administered a single dose of 6 capsules containing tramadol in a randomized crossover manner
DRUG	Placebo	Participants will be administered a single dose of 6 capsules containing placebo in a randomized crossover manner
DRUG	Cebranopadol 600 µg	Participants will be administered a single dose of 6 capsules containing cebranopadol and placebo in a randomized crossover manner
DRUG	Cebranopadol 1000 µg	Participants will be administered a single dose of 6 capsules containing cebranopadol and placebo in a randomized crossover manner

Timeline

• Start date: 2022-03-28
• Primary completion: 2022-07-12
• Completion: 2022-07-12
• First posted: 2022-02-25
• Last updated: 2022-07-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study