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Completed

NCT Number: NCT00999544

Aprepitant Effects on Oxycodone Response

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.

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Key information

Conditions

Narcotic Abuse Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Substance-Related Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky

Lexington, Kentucky, 40502, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aprepitant 0mg

Drug

Aprepitant 0mg, p.o. pretreatment

Aprepitant 40mg

Drug

Aprepitant 40mg, p.o. pretreatment

Aprepitant 200mg

Drug

Aprepitant 200mg, p.o. pretreatment

Oxycodone 0mg, p.o.

Drug

Oxycodone 0mg, p.o.

Oxycodone 20mg, p.o.

Drug

Oxycodone 20mg, p.o.

Oxycodone 40mg, p.o.

Drug

Oxycodone 40mg, p.o.

Oxycodone 0mg, IN

Drug

Oxycodone 0mg, IN

Oxycodone 15mg, IN

Drug

Oxycodone 15mg, IN

Oxycodone 30mg, IN

Drug

Oxycodone 30mg, IN

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Sharon Walsh

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Oct 21, 2009
Registry last updated
Sep 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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