Aprepitant to Mitigate Opioids' Cognitive Side Effects
Primary Purpose
Cognitive Dysfunction
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aprepitant
Placebo
Sponsored by

About this trial
This is an interventional treatment trial for Cognitive Dysfunction focused on measuring drowsiness, loopiness, nausea
Eligibility Criteria
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
Sites / Locations
- University of Arizona Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Aprepitant
Placebo
Arm Description
Aprepitant 40 mg IV pre-operatively 40 mg PO post-op day #1 40 mg PO post-op day #2
electrolyte (0.9% NaCl) infusion) pre-operatively capsule without medication on post-op day #1 capsule without medication on post-op day #2
Outcomes
Primary Outcome Measures
cognitive function
questionnaires
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02226601
Brief Title
Aprepitant to Mitigate Opioids' Cognitive Side Effects
Official Title
Aprepitant to Mitigate Opioids' Cognitive Side Effects
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Arizona
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
In this proposed study the investigators want to examine if the drug aprepitant can decrease the so called "cognitive impairments" opioids may cause, such as drowsiness, loopiness and feeling "high".
This would allow for a better recovery period, in which patients can be more "themselves", participate in activities around them and move forward.
Subjects scheduled for elective surgeries with expected opioid medication for moderate to severe pain and good functional status shortly after surgery will be randomized to receive either aprepitant or placebo shortly before their surgery and for two more days thereafter.
A telephone interview for cognitive status and several specific questions will be used to assess the effect of aprepitant on the subjects' cognitive and functional status.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Dysfunction
Keywords
drowsiness, loopiness, nausea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Aprepitant
Arm Type
Active Comparator
Arm Description
Aprepitant
40 mg IV pre-operatively
40 mg PO post-op day #1
40 mg PO post-op day #2
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
electrolyte (0.9% NaCl) infusion) pre-operatively
capsule without medication on post-op day #1
capsule without medication on post-op day #2
Intervention Type
Drug
Intervention Name(s)
Aprepitant
Other Intervention Name(s)
Emend
Intervention Description
3 days perioperative Aprepitant once a day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
3 days perioperative Placebot once a day
Primary Outcome Measure Information:
Title
cognitive function
Description
questionnaires
Time Frame
3 days post-operatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kai Schoenhage, MD
Phone
5206260373
Email
kschoenhage@anesth.arizona.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kai Schoenhage, MD
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arizona Medical Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kai Schoenhage, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
22260216
Citation
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.
Results Reference
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Aprepitant to Mitigate Opioids' Cognitive Side Effects
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