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Aprepitant for Opioid-Induced Cognitive Impairment

N/A
Waitlist Available
Led By Kai Schoenhage, MD
Research Sponsored by University of Arizona
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
hemodynamically unstable, hemorrhage (bleeding)
therapy with pimozide, terfenadine, astemizole, cisapride, vitamin K antagonists (warfarin), hormonal contraceptives
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 days post-operatively
Awards & highlights

Summary

This trial is testing if a new medication can help to reduce some of these common side effects from opioids, without reducing the pain control that the opioids provide.

Who is the study for?
This trial is for healthy, English-speaking adults who have never taken opioids before. It's not for those who are very overweight, have liver issues, infections, recent surgery or bleeding problems. Pregnant or nursing women and people under 18 can't join either.
What is being tested?
The study is testing if Aprepitant can help with the cognitive side effects of opioids used for pain after surgery. Participants will be randomly given either Aprepitant or a placebo to see which works better.
What are the potential side effects?
Aprepitant may cause headaches, tiredness, hiccups, constipation and other digestive symptoms. However, it's generally considered safe with manageable side effects.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not experiencing uncontrolled bleeding or unstable blood pressure.
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I am not taking medications like pimozide, warfarin, or hormonal contraceptives.
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My immune system is weakened.
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I am not fluent in English.
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I currently have or recently had an infection.
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I am extremely overweight.
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I have been on opioid medication recently or am currently taking it.
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I am under 18 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 days post-operatively
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 days post-operatively for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
cognitive function

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: AprepitantActive Control1 Intervention
Aprepitant * 40 mg IV pre-operatively * 40 mg PO post-op day #1 * 40 mg PO post-op day #2
Group II: PlaceboPlacebo Group1 Intervention
* electrolyte (0.9% NaCl) infusion) pre-operatively * capsule without medication on post-op day #1 * capsule without medication on post-op day #2

Find a Location

Who is running the clinical trial?

University of ArizonaLead Sponsor
525 Previous Clinical Trials
155,198 Total Patients Enrolled
Kai Schoenhage, MDPrincipal InvestigatorUniversity of Arizona
3 Previous Clinical Trials
370 Total Patients Enrolled

Media Library

Aprepitant Clinical Trial Eligibility Overview. Trial Name: NCT02226601 — N/A
Cognitive Impairment Research Study Groups: Aprepitant, Placebo
Cognitive Impairment Clinical Trial 2023: Aprepitant Highlights & Side Effects. Trial Name: NCT02226601 — N/A
Aprepitant 2023 Treatment Timeline for Medical Study. Trial Name: NCT02226601 — N/A
~5 spots leftby Sep 2025
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