New Neural Drug Targets
| Status: | Archived |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | October 2009 |
| End Date: | October 2011 |
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.
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