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Aprepitant Effects on Oxycodone Response

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00999544
First Posted: October 21, 2009
Last Update Posted: September 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institute on Drug Abuse (NIDA)
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Sharon Walsh, University of Kentucky
October 20, 2009
October 21, 2009
November 13, 2012
August 23, 2013
September 1, 2017
October 2009
April 2011   (Final data collection date for primary outcome measure)
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.
Opioid Abuse Liability [ Time Frame: 42 days ]
Complete list of historical versions of study NCT00999544 on ClinicalTrials.gov Archive Site
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.
Aprepitant Side Effects [ Time Frame: 42 days ]
Not Provided
Not Provided
 
Aprepitant Effects on Oxycodone Response
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Within subject crossover designed that examined 15 experimental conditions within a single group of participants
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Narcotic Abuse
  • Drug: Aprepitant 0mg
    Aprepitant 0mg, p.o. pretreatment
  • Drug: Aprepitant 40mg
    Aprepitant 40mg, p.o. pretreatment
  • Drug: Aprepitant 200mg
    Aprepitant 200mg, p.o. pretreatment
  • Drug: Oxycodone 0mg, p.o.
    Oxycodone 0mg, p.o.
  • Drug: Oxycodone 20mg, p.o.
    Oxycodone 20mg, p.o.
  • Drug: Oxycodone 40mg, p.o.
    Oxycodone 40mg, p.o.
  • Drug: Oxycodone 0mg, IN
    Oxycodone 0mg, IN
  • Drug: Oxycodone 15mg, IN
    Oxycodone 15mg, IN
  • Drug: Oxycodone 30mg, IN
    Oxycodone 30mg, IN
  • Experimental: Placebo aprepitant/0 mg oxycodone IN PO
    Placebo aprepitant/Placebo oxycodone IN/PO
    Interventions:
    • Drug: Aprepitant 0mg
    • Drug: Oxycodone 0mg, p.o.
    • Drug: Oxycodone 0mg, IN
  • Experimental: Placebo aprepitant/ oxycodone 15 IN 0 PO
    Placebo aprepitant/ oxycodone 15 IN 0 PO
    Interventions:
    • Drug: Aprepitant 0mg
    • Drug: Oxycodone 0mg, p.o.
    • Drug: Oxycodone 15mg, IN
  • Experimental: Placebo aprepitant/ oxycodone 30 IN 0 PO
    Placebo aprepitant/ oxycodone 30 IN 0 PO
    Interventions:
    • Drug: Aprepitant 0mg
    • Drug: Oxycodone 0mg, p.o.
    • Drug: Oxycodone 30mg, IN
  • Experimental: Placebo aprepitant/ oxycodone 0 IN 20 PO
    Placebo aprepitant/ oxycodone 0 IN 20 PO
    Interventions:
    • Drug: Aprepitant 0mg
    • Drug: Oxycodone 20mg, p.o.
    • Drug: Oxycodone 0mg, IN
  • Experimental: Placebo aprepitant/ oxycodone 0 IN 40 PO
    Placebo aprepitant/ oxycodone 0 IN 40 PO
    Interventions:
    • Drug: Aprepitant 0mg
    • Drug: Oxycodone 40mg, p.o.
    • Drug: Oxycodone 0mg, IN
  • Experimental: Aprepitant 40 mg/ oxycodone 0 IN 0 PO
    Aprepitant 40 mg/ oxycodone 0 IN 0 PO
    Interventions:
    • Drug: Aprepitant 40mg
    • Drug: Oxycodone 0mg, p.o.
    • Drug: Oxycodone 0mg, IN
  • Experimental: Aprepitant 40 mg/ oxycodone 0 IN 20 PO
    Aprepitant 40 mg/ oxycodone 0 IN 20 PO
    Interventions:
    • Drug: Aprepitant 40mg
    • Drug: Oxycodone 20mg, p.o.
    • Drug: Oxycodone 0mg, IN
  • Experimental: Aprepitant 40 mg/ oxycodone 0 IN 40 PO
    Aprepitant 40 mg/ oxycodone 0 IN 40 PO
    Interventions:
    • Drug: Aprepitant 40mg
    • Drug: Oxycodone 40mg, p.o.
    • Drug: Oxycodone 0mg, IN
  • Experimental: Aprepitant 40 mg/ oxycodone 15 IN 0 PO
    Aprepitant 40 mg/ oxycodone 15 IN 0 PO
    Interventions:
    • Drug: Aprepitant 40mg
    • Drug: Oxycodone 0mg, p.o.
    • Drug: Oxycodone 15mg, IN
  • Experimental: Aprepitant 40 mg/ oxycodone 30 IN 0 PO
    Aprepitant 40 mg/ oxycodone 30 IN 0 PO
    Interventions:
    • Drug: Aprepitant 40mg
    • Drug: Oxycodone 0mg, p.o.
    • Drug: Oxycodone 30mg, IN
  • Experimental: Aprepitant 200 mg/ oxycodone 0 IN 0 PO
    Aprepitant 200 mg/ oxycodone 0 IN 0 PO
    Interventions:
    • Drug: Aprepitant 200mg
    • Drug: Oxycodone 0mg, p.o.
    • Drug: Oxycodone 0mg, IN
  • Experimental: Aprepitant 200 mg/ oxycodone 0 IN 20 PO
    Aprepitant 200 mg/ oxycodone 0 IN 20 PO
    Interventions:
    • Drug: Aprepitant 200mg
    • Drug: Oxycodone 20mg, p.o.
    • Drug: Oxycodone 0mg, IN
  • Experimental: Aprepitant 200 mg/ oxycodone 0 IN 40 PO
    Aprepitant 200 mg/ oxycodone 0 IN 40 PO
    Interventions:
    • Drug: Aprepitant 200mg
    • Drug: Oxycodone 40mg, p.o.
    • Drug: Oxycodone 0mg, IN
  • Experimental: Aprepitant 200 mg/ oxycodone 15 IN 0 PO
    Aprepitant 200 mg/ oxycodone 15 IN 0 PO
    Interventions:
    • Drug: Aprepitant 200mg
    • Drug: Oxycodone 0mg, p.o.
    • Drug: Oxycodone 15mg, IN
  • Experimental: Aprepitant 200 mg/ oxycodone 30 IN 0 PO
    Aprepitant 200 mg/ oxycodone 30 IN 0 PO
    Interventions:
    • Drug: Aprepitant 200mg
    • Drug: Oxycodone 0mg, p.o.
    • Drug: Oxycodone 30mg, IN
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
9
April 2011
April 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00999544
09-0446
R01DA027031 ( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
Sharon Walsh, University of Kentucky
Sharon Walsh
  • National Institute on Drug Abuse (NIDA)
  • Merck Sharp & Dohme Corp.
Principal Investigator: Sharon L Walsh, Ph.D. University of Kentucky
University of Kentucky
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP