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Assessment of Abuse Potential of Cebranopadol in Humans

NCT05256108 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2022-07-27

No results posted yet for this study

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.

Conditions

  • Human Abuse Potential

Interventions

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

Sponsors & Collaborators

  • Tris Pharma, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-28
Primary Completion
2022-07-12
Completion
2022-07-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05256108 on ClinicalTrials.gov