Aprepitant Effects on Oxycodone Response
- Conditions
- Narcotic Abuse
- Interventions
- Registration Number
- NCT00999544
- Lead Sponsor
- Sharon Walsh
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 9
- Recreational user of opioids
- Healthy
- Ages 18-55 years old
- Able to provide informed consent
- Ongoing medical or psychiatric condition that would be contraindicated for participation
- Past 30 day use of and P4503A4 inhibitor
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Aprepitant 40 mg/ oxycodone 15 IN 0 PO Oxycodone 0mg, p.o. Aprepitant 40 mg/ oxycodone 15 IN 0 PO Aprepitant 40 mg/ oxycodone 15 IN 0 PO Oxycodone 15mg, IN Aprepitant 40 mg/ oxycodone 15 IN 0 PO Aprepitant 40 mg/ oxycodone 30 IN 0 PO Oxycodone 30mg, IN Aprepitant 40 mg/ oxycodone 30 IN 0 PO Placebo aprepitant/ oxycodone 0 IN 40 PO Aprepitant 0mg Placebo aprepitant/ oxycodone 0 IN 40 PO Aprepitant 40 mg/ oxycodone 0 IN 40 PO Aprepitant 40mg Aprepitant 40 mg/ oxycodone 0 IN 40 PO Aprepitant 200 mg/ oxycodone 0 IN 0 PO Aprepitant 200mg Aprepitant 200 mg/ oxycodone 0 IN 0 PO Aprepitant 200 mg/ oxycodone 0 IN 20 PO Aprepitant 200mg Aprepitant 200 mg/ oxycodone 0 IN 20 PO Placebo aprepitant/ oxycodone 0 IN 20 PO Oxycodone 0mg, IN Placebo aprepitant/ oxycodone 0 IN 20 PO Aprepitant 40 mg/ oxycodone 0 IN 20 PO Oxycodone 0mg, IN Aprepitant 40 mg/ oxycodone 0 IN 20 PO Placebo aprepitant/ oxycodone 30 IN 0 PO Oxycodone 30mg, IN Placebo aprepitant/ oxycodone 30 IN 0 PO Placebo aprepitant/0 mg oxycodone IN PO Aprepitant 0mg Placebo aprepitant/Placebo oxycodone IN/PO Placebo aprepitant/0 mg oxycodone IN PO Oxycodone 0mg, p.o. Placebo aprepitant/Placebo oxycodone IN/PO Placebo aprepitant/0 mg oxycodone IN PO Oxycodone 0mg, IN Placebo aprepitant/Placebo oxycodone IN/PO Placebo aprepitant/ oxycodone 15 IN 0 PO Aprepitant 0mg Placebo aprepitant/ oxycodone 15 IN 0 PO Placebo aprepitant/ oxycodone 15 IN 0 PO Oxycodone 0mg, p.o. Placebo aprepitant/ oxycodone 15 IN 0 PO Placebo aprepitant/ oxycodone 15 IN 0 PO Oxycodone 15mg, IN Placebo aprepitant/ oxycodone 15 IN 0 PO Placebo aprepitant/ oxycodone 30 IN 0 PO Aprepitant 0mg Placebo aprepitant/ oxycodone 30 IN 0 PO Placebo aprepitant/ oxycodone 30 IN 0 PO Oxycodone 0mg, p.o. Placebo aprepitant/ oxycodone 30 IN 0 PO Aprepitant 40 mg/ oxycodone 0 IN 20 PO Oxycodone 20mg, p.o. Aprepitant 40 mg/ oxycodone 0 IN 20 PO Placebo aprepitant/ oxycodone 0 IN 20 PO Aprepitant 0mg Placebo aprepitant/ oxycodone 0 IN 20 PO Placebo aprepitant/ oxycodone 0 IN 20 PO Oxycodone 20mg, p.o. Placebo aprepitant/ oxycodone 0 IN 20 PO Placebo aprepitant/ oxycodone 0 IN 40 PO Oxycodone 40mg, p.o. Placebo aprepitant/ oxycodone 0 IN 40 PO Placebo aprepitant/ oxycodone 0 IN 40 PO Oxycodone 0mg, IN Placebo aprepitant/ oxycodone 0 IN 40 PO Aprepitant 40 mg/ oxycodone 0 IN 0 PO Aprepitant 40mg Aprepitant 40 mg/ oxycodone 0 IN 0 PO Aprepitant 40 mg/ oxycodone 0 IN 0 PO Oxycodone 0mg, p.o. Aprepitant 40 mg/ oxycodone 0 IN 0 PO Aprepitant 40 mg/ oxycodone 0 IN 0 PO Oxycodone 0mg, IN Aprepitant 40 mg/ oxycodone 0 IN 0 PO Aprepitant 40 mg/ oxycodone 0 IN 20 PO Aprepitant 40mg Aprepitant 40 mg/ oxycodone 0 IN 20 PO Aprepitant 40 mg/ oxycodone 0 IN 40 PO Oxycodone 0mg, IN Aprepitant 40 mg/ oxycodone 0 IN 40 PO Aprepitant 40 mg/ oxycodone 15 IN 0 PO Aprepitant 40mg Aprepitant 40 mg/ oxycodone 15 IN 0 PO Aprepitant 40 mg/ oxycodone 0 IN 40 PO Oxycodone 40mg, p.o. Aprepitant 40 mg/ oxycodone 0 IN 40 PO Aprepitant 40 mg/ oxycodone 30 IN 0 PO Aprepitant 40mg Aprepitant 40 mg/ oxycodone 30 IN 0 PO Aprepitant 40 mg/ oxycodone 30 IN 0 PO Oxycodone 0mg, p.o. Aprepitant 40 mg/ oxycodone 30 IN 0 PO Aprepitant 200 mg/ oxycodone 0 IN 0 PO Oxycodone 0mg, p.o. Aprepitant 200 mg/ oxycodone 0 IN 0 PO Aprepitant 200 mg/ oxycodone 0 IN 0 PO Oxycodone 0mg, IN Aprepitant 200 mg/ oxycodone 0 IN 0 PO Aprepitant 200 mg/ oxycodone 0 IN 20 PO Oxycodone 20mg, p.o. Aprepitant 200 mg/ oxycodone 0 IN 20 PO Aprepitant 200 mg/ oxycodone 0 IN 20 PO Oxycodone 0mg, IN Aprepitant 200 mg/ oxycodone 0 IN 20 PO Aprepitant 200 mg/ oxycodone 0 IN 40 PO Aprepitant 200mg Aprepitant 200 mg/ oxycodone 0 IN 40 PO Aprepitant 200 mg/ oxycodone 15 IN 0 PO Oxycodone 15mg, IN Aprepitant 200 mg/ oxycodone 15 IN 0 PO Aprepitant 200 mg/ oxycodone 30 IN 0 PO Aprepitant 200mg Aprepitant 200 mg/ oxycodone 30 IN 0 PO Aprepitant 200 mg/ oxycodone 30 IN 0 PO Oxycodone 0mg, p.o. Aprepitant 200 mg/ oxycodone 30 IN 0 PO Aprepitant 200 mg/ oxycodone 0 IN 40 PO Oxycodone 40mg, p.o. Aprepitant 200 mg/ oxycodone 0 IN 40 PO Aprepitant 200 mg/ oxycodone 0 IN 40 PO Oxycodone 0mg, IN Aprepitant 200 mg/ oxycodone 0 IN 40 PO Aprepitant 200 mg/ oxycodone 15 IN 0 PO Aprepitant 200mg Aprepitant 200 mg/ oxycodone 15 IN 0 PO Aprepitant 200 mg/ oxycodone 15 IN 0 PO Oxycodone 0mg, p.o. Aprepitant 200 mg/ oxycodone 15 IN 0 PO Aprepitant 200 mg/ oxycodone 30 IN 0 PO Oxycodone 30mg, IN Aprepitant 200 mg/ oxycodone 30 IN 0 PO
- Primary Outcome Measures
Name Time Method Abuse Liability Proxy 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
Name Time Method Respiration Depression 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.
Trial Locations
- Locations (1)
University of Kentucky
🇺🇸Lexington, Kentucky, United States