Aprepitant Effects on Oxycodone Response
New Neural Drug Targets: An Evaluation of the Effects of Aprepitant on the Response to Oxycodone
2 other identifiers
interventional
9
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 20, 2009
CompletedFirst Posted
Study publicly available on registry
October 21, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedResults Posted
Study results publicly available
August 23, 2013
CompletedSeptember 1, 2017
August 1, 2017
1.5 years
October 20, 2009
November 13, 2012
August 3, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Abuse Liability Proxy
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 Outcomes (1)
Respiration Depression
42 days
Study Arms (15)
Placebo aprepitant/0 mg oxycodone IN PO
EXPERIMENTALPlacebo aprepitant/Placebo oxycodone IN/PO
Placebo aprepitant/ oxycodone 15 IN 0 PO
EXPERIMENTALPlacebo aprepitant/ oxycodone 15 IN 0 PO
Placebo aprepitant/ oxycodone 30 IN 0 PO
EXPERIMENTALPlacebo aprepitant/ oxycodone 30 IN 0 PO
Placebo aprepitant/ oxycodone 0 IN 20 PO
EXPERIMENTALPlacebo aprepitant/ oxycodone 0 IN 20 PO
Placebo aprepitant/ oxycodone 0 IN 40 PO
EXPERIMENTALPlacebo aprepitant/ oxycodone 0 IN 40 PO
Aprepitant 40 mg/ oxycodone 0 IN 0 PO
EXPERIMENTALAprepitant 40 mg/ oxycodone 0 IN 0 PO
Aprepitant 40 mg/ oxycodone 0 IN 20 PO
EXPERIMENTALAprepitant 40 mg/ oxycodone 0 IN 20 PO
Aprepitant 40 mg/ oxycodone 0 IN 40 PO
EXPERIMENTALAprepitant 40 mg/ oxycodone 0 IN 40 PO
Aprepitant 40 mg/ oxycodone 15 IN 0 PO
EXPERIMENTALAprepitant 40 mg/ oxycodone 15 IN 0 PO
Aprepitant 40 mg/ oxycodone 30 IN 0 PO
EXPERIMENTALAprepitant 40 mg/ oxycodone 30 IN 0 PO
Aprepitant 200 mg/ oxycodone 0 IN 0 PO
EXPERIMENTALAprepitant 200 mg/ oxycodone 0 IN 0 PO
Aprepitant 200 mg/ oxycodone 0 IN 20 PO
EXPERIMENTALAprepitant 200 mg/ oxycodone 0 IN 20 PO
Aprepitant 200 mg/ oxycodone 0 IN 40 PO
EXPERIMENTALAprepitant 200 mg/ oxycodone 0 IN 40 PO
Aprepitant 200 mg/ oxycodone 15 IN 0 PO
EXPERIMENTALAprepitant 200 mg/ oxycodone 15 IN 0 PO
Aprepitant 200 mg/ oxycodone 30 IN 0 PO
EXPERIMENTALAprepitant 200 mg/ oxycodone 30 IN 0 PO
Interventions
Aprepitant 0mg, p.o. pretreatment
Aprepitant 40mg, p.o. pretreatment
Aprepitant 200mg, p.o. pretreatment
Oxycodone 0mg, p.o.
Oxycodone 20mg, p.o.
Oxycodone 40mg, p.o.
Oxycodone 0mg, IN
Oxycodone 15mg, IN
Oxycodone 30mg, IN
Eligibility Criteria
You may qualify if:
- Recreational user of opioids
- Healthy
- Ages 18-55 years old
- Able to provide informed consent
You may not qualify if:
- Ongoing medical or psychiatric condition that would be contraindicated for participation
- Past 30 day use of and P4503A4 inhibitor
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sharon Walshlead
- National Institute on Drug Abuse (NIDA)collaborator
- Merck Sharp & Dohme LLCcollaborator
Study Sites (1)
University of Kentucky
Lexington, Kentucky, 40502, United States
Related Publications (1)
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.
PMID: 22260216RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
No significant adverse effects occurred. No adverse events led to study drop-out.
Results Point of Contact
- Title
- Dr. Sharon Walsh
- Organization
- University of Kentucky
Study Officials
- PRINCIPAL INVESTIGATOR
Sharon L Walsh, Ph.D.
University of Kentucky
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director Center on Drug and Alcohol Research
Study Record Dates
First Submitted
October 20, 2009
First Posted
October 21, 2009
Study Start
October 1, 2009
Primary Completion
April 1, 2011
Study Completion
April 1, 2011
Last Updated
September 1, 2017
Results First Posted
August 23, 2013
Record last verified: 2017-08