NCT02226601

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 27, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Last Updated

June 2, 2015

Status Verified

May 1, 2015

Enrollment Period

2 years

First QC Date

August 21, 2014

Last Update Submit

May 29, 2015

Conditions

Cognitive Dysfunction

Keywords

drowsinessloopinessnausea

Outcome Measures

Primary Outcomes (1)

  • cognitive function

    questionnaires

    3 days post-operatively

Study Arms (2)

Aprepitant

ACTIVE COMPARATOR

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

Drug: Aprepitant

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

AprepitantDRUG

3 days perioperative Aprepitant once a day

Also known as: Emend
Aprepitant
PlaceboDRUG

3 days perioperative Placebot once a day

Placebo

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy English speaking, opioid-naive consenting adults

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arizona Medical Center

Tucson, Arizona, 85724, United States

RECRUITING

Related Publications (1)

  • Walsh SL, Heilig M, Nuzzo PA, Henderson P, Lofwall MR. Effects of the NK1 antagonist, aprepitant, on response to oral and intranasal oxycodone in prescription opioid abusers. Addict Biol. 2013 Mar;18(2):332-43. doi: 10.1111/j.1369-1600.2011.00419.x. Epub 2012 Jan 19.

    PMID: 22260216BACKGROUND

MeSH Terms

Conditions

Cognitive DysfunctionSleepinessNausea

Interventions

Aprepitant

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

MorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Kai Schoenhage, MD

    University of Arizona

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kai Schoenhage, MD

CONTACT

5206260373kschoenhage@anesth.arizona.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 21, 2014

First Posted

August 27, 2014

Study Start

October 1, 2014

Primary Completion

October 1, 2016

Last Updated

June 2, 2015

Record last verified: 2015-05

Locations

US(1)