Aprepitant to Mitigate Opioids' Cognitive Side Effects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cognitive Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Aprepitant

Aprepitant

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

Group Type ACTIVE_COMPARATOR

Aprepitant

Intervention Type DRUG

3 days perioperative Aprepitant once a day

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

3 days perioperative Placebot once a day

Interventions

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Aprepitant

3 days perioperative Aprepitant once a day

Intervention Type DRUG

Placebo

3 days perioperative Placebot once a day

Intervention Type DRUG

Other Intervention Names

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Emend

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes