Aprepitant to Mitigate Opioids' Cognitive Side Effects

Cognitive Dysfunction Clinical Trial

Official title:

Aprepitant to Mitigate Opioids' Cognitive Side Effects

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02226601
• Other study ID #: CognAp
• Status: Recruiting
• Phase: N/A
• First received: August 21, 2014
• Last updated: May 29, 2015
• Start date: October 2014

Study information

• Verified date: May 2015
• Source: University of Arizona
• Contact: Kai Schoenhage, MD
• Phone: 5206260373
• Email: kschoenhage[@]anesth.arizona.edu
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Dysfunction

Intervention

Drug:
• Aprepitant
3 days perioperative Aprepitant once a day
• Placebo
3 days perioperative Placebot once a day

Locations

Country	Name	City	State
United States	University of Arizona Medical Center	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cognitive function	questionnaires	3 days post-operatively	No