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Cebranopadol 600 µg for Substance Abuse

Phase 1
Waitlist Available
Research Sponsored by Tris Pharma, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Willing and able to provide written informed consent
Adult men or women aged 18 to 55 years, inclusive
Timeline
Screening 3 weeks
Treatment Varies
Follow Up treatment phase: intervals from predose to 48 hours post-dose
Awards & highlights

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~treatment phase: intervals from predose to 48 hours post-dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and treatment phase: intervals from predose to 48 hours post-dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Drug Liking Visual analog scale (VAS) Emax
Secondary outcome measures
Multi-Tasking Test
Pupillometry
VAS rating for Overall Liking
+1 more

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Cebranopadol 600 µgExperimental Treatment1 Intervention
Single oral dose of 6 capsules containing 3 cebranopadol 200 µg tablets and placebo
Group II: Cebranopadol 1000 µgExperimental Treatment1 Intervention
Single oral dose of 6 capsules containing 5 cebranopadol 200 µg tablets and placebo
Group III: Oxycodone 40 mgActive Control1 Intervention
Single oral dose of 6 capsules containing 2 oxycodone 20 mg and placebo
Group IV: Tramadol 600 mgActive Control1 Intervention
Single oral dose of 6 capsules containing 6 tramadol 100 mg tablets
Group V: PlaceboPlacebo Group1 Intervention
Single oral dose of 6 capsules containing placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cebranopadol 600 µg
2013
Completed Phase 2
~740
Cebranopadol 1000 µg
2022
Completed Phase 1
~40

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Tris Pharma, Inc.Lead Sponsor
18 Previous Clinical Trials
4,190 Total Patients Enrolled
1 Trials studying Substance Abuse
226 Patients Enrolled for Substance Abuse

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~13 spots leftby Mar 2025