NCT00999544

Aprepitant Effects on Oxycodone Response

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Sharon Walsh · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Narcotic Abuse

Interventions

Type	Name	Description
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

Timeline

• Start date: 2009-10-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2009-10-21
• Last updated: 2017-09-01
• Results posted: 2013-08-23

Locations

1 site across 1 country: United States