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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
9

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sharon Walsh

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2009

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2011

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 20, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 20, 2009

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 21, 2009

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 1, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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