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Aprepitant Effects on Oxycodone Response

This study has been completed.
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Sharon Walsh, University of Kentucky
ClinicalTrials.gov Identifier:
NCT00999544
First received: October 20, 2009
Last updated: July 5, 2017
Last verified: July 2017
  Purpose
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.

Condition Intervention
Narcotic Abuse Drug: Placebo aprepitant/0 mg oxycodone IN PO Drug: Placebo aprepitant/ oxycodone 15 IN 0 PO Drug: Placebo aprepitant/ oxycodone 30 IN 0 PO Drug: Placebo aprepitant/ oxycodone 0 IN 20 PO Drug: Placebo aprepitant/ oxycodone 0 IN 40 PO Drug: Aprepitant 40 mg/ oxycodone 0 IN 0 PO Drug: Aprepitant 40 mg/ oxycodone 0 IN 20 PO Drug: Aprepitant 40 mg/ oxycodone 0 IN 40 PO Drug: Aprepitant 40 mg/ oxycodone 15 IN 0 PO Drug: Aprepitant 40 mg/ oxycodone 30 IN 0 PO Drug: Aprepitant 200 mg/ oxycodone 0 IN 0 PO Drug: Aprepitant 200 mg/ oxycodone 0 IN 20 PO Drug: Aprepitant 200 mg/ oxycodone 0 IN 40 PO Drug: Aprepitant 200 mg/ oxycodone 15 IN 0 PO Drug: Aprepitant 200 mg/ oxycodone 30 IN 0 PO

Study Type: Interventional
Study Design: 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
Official Title: New Neural Drug Targets: An Evaluation of the Effects of Aprepitant on the Response to Oxycodone

Resource links provided by NLM:


Further study details as provided by Sharon Walsh, University of Kentucky:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Aprepitant Side Effects [ Time Frame: 42 days ]

Enrollment: 9
Study Start Date: October 2009
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Placebo aprepitant/0 mg oxycodone IN PO
Placebo aprepitant/Placebo oxycodone IN/PO
Drug: Placebo aprepitant/0 mg oxycodone IN PO
Aprepitant (0mg, p.o.) pretreatment, Oxycodone (0mg, IN), and Oxycodone (0mg, p.o.)
Experimental: Placebo aprepitant/ oxycodone 15 IN 0 PO
Placebo aprepitant/ oxycodone 15 IN 0 PO
Drug: Placebo aprepitant/ oxycodone 15 IN 0 PO
Aprepitant (0mg, p.o.) pretreatment, Oxycodone (15mg, IN), and Oxycodone (0mg, p.o.)
Other Name: Lactose
Experimental: Placebo aprepitant/ oxycodone 30 IN 0 PO
Placebo aprepitant/ oxycodone 30 IN 0 PO
Drug: Placebo aprepitant/ oxycodone 30 IN 0 PO
Aprepitant (0mg, p.o.) pretreatment, Oxycodone (30mg, IN), and Oxycodone (0mg, p.o.)
Experimental: Placebo aprepitant/ oxycodone 0 IN 20 PO
Placebo aprepitant/ oxycodone 0 IN 20 PO
Drug: Placebo aprepitant/ oxycodone 0 IN 20 PO
Aprepitant (0mg, p.o.) pretreatment, Oxycodone (0mg, IN), and Oxycodone (20mg, p.o.)
Experimental: Placebo aprepitant/ oxycodone 0 IN 40 PO
Placebo aprepitant/ oxycodone 0 IN 40 PO
Drug: Placebo aprepitant/ oxycodone 0 IN 40 PO
Aprepitant (0mg, p.o.) pretreatment, Oxycodone (0mg, IN), and Oxycodone (40mg, p.o.)
Experimental: Aprepitant 40 mg/ oxycodone 0 IN 0 PO
Aprepitant 40 mg/ oxycodone 0 IN 0 PO
Drug: Aprepitant 40 mg/ oxycodone 0 IN 0 PO
Aprepitant (40mg, p.o.) pretreatment, Oxycodone (0mg, IN), and Oxycodone (0mg, p.o.)
Experimental: Aprepitant 40 mg/ oxycodone 0 IN 20 PO
Aprepitant 40 mg/ oxycodone 0 IN 20 PO
Drug: Aprepitant 40 mg/ oxycodone 0 IN 20 PO
Aprepitant (40mg, p.o.) pretreatment, Oxycodone (0mg, IN), and Oxycodone (20mg, p.o.)
Experimental: Aprepitant 40 mg/ oxycodone 0 IN 40 PO
Aprepitant 40 mg/ oxycodone 0 IN 40 PO
Drug: Aprepitant 40 mg/ oxycodone 0 IN 40 PO
Aprepitant (40mg, p.o.) pretreatment, Oxycodone (0mg, IN), and Oxycodone (40mg, p.o.)
Experimental: Aprepitant 40 mg/ oxycodone 15 IN 0 PO
Aprepitant 40 mg/ oxycodone 15 IN 0 PO
Drug: Aprepitant 40 mg/ oxycodone 15 IN 0 PO
Aprepitant (40mg, p.o.) pretreatment, Oxycodone (15mg, IN), and Oxycodone (0mg, p.o.)
Experimental: Aprepitant 40 mg/ oxycodone 30 IN 0 PO
Aprepitant 40 mg/ oxycodone 30 IN 0 PO
Drug: Aprepitant 40 mg/ oxycodone 30 IN 0 PO
Aprepitant (40mg, p.o.) pretreatment, Oxycodone (30mg, IN), and Oxycodone (0mg, p.o.)
Experimental: Aprepitant 200 mg/ oxycodone 0 IN 0 PO
Aprepitant 200 mg/ oxycodone 0 IN 0 PO
Drug: Aprepitant 200 mg/ oxycodone 0 IN 0 PO
Aprepitant (200mg, p.o.) pretreatment, Oxycodone (0mg, IN), and Oxycodone (0mg, p.o.)
Experimental: Aprepitant 200 mg/ oxycodone 0 IN 20 PO
Aprepitant 200 mg/ oxycodone 0 IN 20 PO
Drug: Aprepitant 200 mg/ oxycodone 0 IN 20 PO
Aprepitant (200mg, p.o.) pretreatment, Oxycodone (0mg, IN), and Oxycodone (20mg, p.o.)
Experimental: Aprepitant 200 mg/ oxycodone 0 IN 40 PO
Aprepitant 200 mg/ oxycodone 0 IN 40 PO
Drug: Aprepitant 200 mg/ oxycodone 0 IN 40 PO
Aprepitant (200mg, p.o.) pretreatment, Oxycodone (0mg, IN), and Oxycodone (40mg, p.o.)
Experimental: Aprepitant 200 mg/ oxycodone 15 IN 0 PO
Aprepitant 200 mg/ oxycodone 15 IN 0 PO
Drug: Aprepitant 200 mg/ oxycodone 15 IN 0 PO
Aprepitant (200mg, p.o.) pretreatment, Oxycodone (15mg, IN), and Oxycodone (0mg, p.o.)
Experimental: Aprepitant 200 mg/ oxycodone 30 IN 0 PO
Aprepitant 200 mg/ oxycodone 30 IN 0 PO
Drug: Aprepitant 200 mg/ oxycodone 30 IN 0 PO
Aprepitant (200mg, p.o.) pretreatment, Oxycodone (30mg, IN), and Oxycodone (0mg, p.o.)

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.
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00999544

Locations
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40502
Sponsors and Collaborators
Sharon Walsh
National Institute on Drug Abuse (NIDA)
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Sharon L Walsh, Ph.D. University of Kentucky
  More Information

Publications:
Responsible Party: Sharon Walsh, Director Center on Drug and Alcohol Research, University of Kentucky
ClinicalTrials.gov Identifier: NCT00999544     History of Changes
Other Study ID Numbers: 09-0446
R01DA027031 ( U.S. NIH Grant/Contract )
Study First Received: October 20, 2009
Results First Received: November 13, 2012
Last Updated: July 5, 2017

Keywords provided by Sharon Walsh, University of Kentucky:
opioid
oxycodone
NK1 antagonist
aprepitant
intranasal
abuse

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Oxycodone
Aprepitant
Fosaprepitant
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 23, 2017