Recruiting

Aprepitant with Opioids

Sponsor:

University of Arizona

Code:

NCT02226601

Conditions

Cognitive Dysfunction

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Aprepitant

Placebo

Study Details

Brief summary:

Morphine and similar substances (called opioids) are often prescribed for moderate to severe pain, such as after a surgery, thus allowing for minimal pain and a better recovery. Unfortunately various, non-dangerous side effects from opioids occur often that limit the way patients feel and can take of themselves, despite otherwise good pain control and minimal limitations from the surgery itself.

Conditions

Cognitive Dysfunction

Study ID

NCT02226601

Start date

Oct, 2014

Status verified date

May, 2015

Primary completion date

Oct, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • healthy English speaking, opioid-naive consenting adults

Exclusion Criteria:

  • current or very recent (< 3 months) opioid therapy
  • morbid obesity
  • liver disease
  • therapy with pimozide, terfenadine, astemizole, cisapride, vitamin K antagonists (warfarin), hormonal contraceptives
  • acute or chronic infections
  • immunocompromised status
  • hemodynamically unstable, hemorrhage (bleeding)
  • recent surgery
  • pregnancy, nursing
  • younger than 18 years old
  • not proficient of the English language

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Aprepitant

Aprepitant

  • 40 mg IV pre-operatively
  • 40 mg PO post-op day #1
  • 40 mg PO post-op day #2

placebo comparator: Placebo

  • electrolyte (0.9% NaCl) infusion) pre-operatively
  • capsule without medication on post-op day #1
  • capsule without medication on post-op day #2

Interventions

Aprepitant

3 days perioperative Aprepitant once a day

Placebo

3 days perioperative Placebot once a day

Primary outcome measure

  • cognitive function [ Time Frame: 3 days post-operatively ]

Central Contacts and Locations

Central contacts

Kai Schoenhage, MD

5206260373kschoenhage@anesth.arizona.edu

Locations

University of Arizona Medical Center

Recruiting

Tucson, Arizona, United States, 85724

Principal Investigator:

Kai Schoenhage, MD

More Information

Sponsor

University of Arizona

Last update posted

Jun 2, 2015

Last verified

May, 2015

Keywords

  • drowsiness
  • loopiness
  • nausea

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Arizona on 2015-06-02.