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Aprepitant to Mitigate Opioids' Cognitive Side Effects

Aprepitant to Mitigate Opioids' Cognitive Side Effects

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02226601
Enrollment
50
Registered
2014-08-27
Start date
2014-10-31
Completion date
Unknown
Last updated
2015-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Dysfunction

Keywords

drowsiness, loopiness, nausea

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.

Interventions

DRUGAprepitant

3 days perioperative Aprepitant once a day

DRUGPlacebo

3 days perioperative Placebot once a day

Sponsors

University of Arizona
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
cognitive function3 days post-operativelyquestionnaires

Countries

United States

Contacts

Primary ContactKai Schoenhage, MD
kschoenhage@anesth.arizona.edu5206260373

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026