N/A
Completed N=9
Aprepitant Effects on Oxycodone Response
Narcotic Abuse
Source: ClinicalTrials.gov NCT00999544 ↗
Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Aug 2013
Primary outcomePrimary: Abuse Liability Proxy — 0.197; 0.483; 0.159; 7.678 units on a scale (points 0-100) — p=<.05
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Abuse Liability Proxy |
0.197; 0.483; 0.159; 7.678; 17.450; 9.850 | <.05 sig |
| SECONDARY Respiration Depression |
13.75; 11.63; 11.25; 12.13; 10.25; 12.25 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00999544). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.