Aprepitant Effects on Oxycodone Response

August 3, 2017 updated by: Sharon Walsh

New Neural Drug Targets: An Evaluation of the Effects of Aprepitant on the Response to Oxycodone

Addressing the issue of opioid dependence and tolerance has public health implications for the treatment of opioid abuse (both heroin as well as pharmaceutical opioids) and for the treatment of pain. Recent preclinical data suggest a role for Substance P (NK-1) receptors in modulating both the acute and chronic response to opioids. The objective of this study is to determine whether pretreatment with aprepitant, a selective neurokinin-1 (NK-1) antagonist can reduce the direct response to an opioid agonist (oxycodone) on measures related to abuse liability and reinforcing effects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Healthy adult volunteers with histories of illicit opioid use by the intranasal and oral routes will be admitted to this 6-week inpatient, crossover study. They will participate in 15 experimental test sessions, each lasting approximately 6.5 hours, during which they will receive a range of acute doses of aprepitant, including placebo, followed by challenge with oxycodone or placebo (given intranasally or orally). Multi-dimensional outcomes, including physiological (blood pressure, oxygen saturation, pupil diameter), subjective (questionnaires related to mood, abuse liability) and observer ratings will be collected repeatedly throughout each session. Data will be analyzed using parametric approaches to within-subject designs.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40502
        • University Of Kentucky

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Recreational user of opioids
  • Healthy
  • Ages 18-55 years old
  • Able to provide informed consent

Exclusion Criteria:

  • Ongoing medical or psychiatric condition that would be contraindicated for participation
  • Past 30 day use of and P4503A4 inhibitor

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Placebo aprepitant/0 mg oxycodone IN PO
Placebo aprepitant/Placebo oxycodone IN/PO
Drug: Aprepitant 0mg
Aprepitant 0mg, p.o. pretreatment
Drug: Oxycodone 0mg, p.o.
Oxycodone 0mg, p.o.
Drug: Oxycodone 0mg, IN
Oxycodone 0mg, IN
EXPERIMENTAL: Placebo aprepitant/ oxycodone 15 IN 0 PO
Drug: Aprepitant 0mg
Aprepitant 0mg, p.o. pretreatment
Drug: Oxycodone 0mg, p.o.
Oxycodone 0mg, p.o.
Drug: Oxycodone 15mg, IN
Oxycodone 15mg, IN
EXPERIMENTAL: Placebo aprepitant/ oxycodone 30 IN 0 PO
Drug: Aprepitant 0mg
Aprepitant 0mg, p.o. pretreatment
Drug: Oxycodone 0mg, p.o.
Oxycodone 0mg, p.o.
Drug: Oxycodone 30mg, IN
Oxycodone 30mg, IN
EXPERIMENTAL: Placebo aprepitant/ oxycodone 0 IN 20 PO
Drug: Aprepitant 0mg
Aprepitant 0mg, p.o. pretreatment
Drug: Oxycodone 0mg, IN
Oxycodone 0mg, IN
Drug: Oxycodone 20mg, p.o.
Oxycodone 20mg, p.o.
EXPERIMENTAL: Placebo aprepitant/ oxycodone 0 IN 40 PO
Drug: Aprepitant 0mg
Aprepitant 0mg, p.o. pretreatment
Drug: Oxycodone 0mg, IN
Oxycodone 0mg, IN
Drug: Oxycodone 40mg, p.o.
Oxycodone 40mg, p.o.
EXPERIMENTAL: Aprepitant 40 mg/ oxycodone 0 IN 0 PO
Drug: Oxycodone 0mg, p.o.
Oxycodone 0mg, p.o.
Drug: Oxycodone 0mg, IN
Oxycodone 0mg, IN
Drug: Aprepitant 40mg
Aprepitant 40mg, p.o. pretreatment
EXPERIMENTAL: Aprepitant 40 mg/ oxycodone 0 IN 20 PO
Drug: Oxycodone 0mg, IN
Oxycodone 0mg, IN
Drug: Oxycodone 20mg, p.o.
Oxycodone 20mg, p.o.
Drug: Aprepitant 40mg
Aprepitant 40mg, p.o. pretreatment
EXPERIMENTAL: Aprepitant 40 mg/ oxycodone 0 IN 40 PO
Drug: Oxycodone 0mg, IN
Oxycodone 0mg, IN
Drug: Oxycodone 40mg, p.o.
Oxycodone 40mg, p.o.
Drug: Aprepitant 40mg
Aprepitant 40mg, p.o. pretreatment
EXPERIMENTAL: Aprepitant 40 mg/ oxycodone 15 IN 0 PO
Drug: Oxycodone 0mg, p.o.
Oxycodone 0mg, p.o.
Drug: Oxycodone 15mg, IN
Oxycodone 15mg, IN
Drug: Aprepitant 40mg
Aprepitant 40mg, p.o. pretreatment
EXPERIMENTAL: Aprepitant 40 mg/ oxycodone 30 IN 0 PO
Drug: Oxycodone 0mg, p.o.
Oxycodone 0mg, p.o.
Drug: Oxycodone 30mg, IN
Oxycodone 30mg, IN
Drug: Aprepitant 40mg
Aprepitant 40mg, p.o. pretreatment
EXPERIMENTAL: Aprepitant 200 mg/ oxycodone 0 IN 0 PO
Drug: Oxycodone 0mg, p.o.
Oxycodone 0mg, p.o.
Drug: Oxycodone 0mg, IN
Oxycodone 0mg, IN
Drug: Aprepitant 200mg
Aprepitant 200mg, p.o. pretreatment
EXPERIMENTAL: Aprepitant 200 mg/ oxycodone 0 IN 20 PO
Drug: Oxycodone 0mg, IN
Oxycodone 0mg, IN
Drug: Oxycodone 20mg, p.o.
Oxycodone 20mg, p.o.
Drug: Aprepitant 200mg
Aprepitant 200mg, p.o. pretreatment
EXPERIMENTAL: Aprepitant 200 mg/ oxycodone 0 IN 40 PO
Drug: Oxycodone 0mg, IN
Oxycodone 0mg, IN
Drug: Oxycodone 40mg, p.o.
Oxycodone 40mg, p.o.
Drug: Aprepitant 200mg
Aprepitant 200mg, p.o. pretreatment
EXPERIMENTAL: Aprepitant 200 mg/ oxycodone 15 IN 0 PO
Drug: Oxycodone 0mg, p.o.
Oxycodone 0mg, p.o.
Drug: Oxycodone 15mg, IN
Oxycodone 15mg, IN
Drug: Aprepitant 200mg
Aprepitant 200mg, p.o. pretreatment
EXPERIMENTAL: Aprepitant 200 mg/ oxycodone 30 IN 0 PO
Drug: Oxycodone 0mg, p.o.
Oxycodone 0mg, p.o.
Drug: Oxycodone 30mg, IN
Oxycodone 30mg, IN
Drug: Aprepitant 200mg
Aprepitant 200mg, p.o. pretreatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Abuse Liability Proxy
Time Frame: 42 days
Visual analog scale ratings (from 0-100) on the subject-rated measure of "How much do you like the drug?" with higher scores indicating greater abuse liability (and 100 anchored with "extremely" and zero indicating none anchored with "none at all." Data were collected across multiple time points but the peak maximum score was used for the primary outcome measure.
42 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiration Depression
Time Frame: 42 days
Respiration rate measured over 60 seconds. Data were collected across multiple time points, but the peak minimum score was used for this outcome measure.
42 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sharon Walsh

Collaborators

National Institute on Drug Abuse (NIDA)
Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (ACTUAL)

April 1, 2011

Study Completion (ACTUAL)

April 1, 2011

Study Registration Dates

First Submitted

October 20, 2009

First Submitted That Met QC Criteria

October 20, 2009

First Posted (ESTIMATE)

October 21, 2009

Study Record Updates

Last Update Posted (ACTUAL)

September 1, 2017

Last Update Submitted That Met QC Criteria

August 3, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-0446
  • R01DA027031 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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