Aprepitant Effects on Oxycodone Response

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2011-04-30

Brief Summary

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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.

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Detailed Description

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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

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Narcotic Abuse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Within subject crossover designed that examined 15 experimental conditions within a single group of participants

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo aprepitant/0 mg oxycodone IN PO

Placebo aprepitant/Placebo oxycodone IN/PO

Group Type EXPERIMENTAL

Aprepitant 0mg

Intervention Type DRUG

Aprepitant 0mg, p.o. pretreatment

Oxycodone 0mg, p.o.

Intervention Type DRUG

Oxycodone 0mg, p.o.

Oxycodone 0mg, IN

Intervention Type DRUG

Oxycodone 0mg, IN

Placebo aprepitant/ oxycodone 15 IN 0 PO

Group Type EXPERIMENTAL

Aprepitant 0mg

Intervention Type DRUG

Aprepitant 0mg, p.o. pretreatment

Oxycodone 0mg, p.o.

Intervention Type DRUG

Oxycodone 0mg, p.o.

Oxycodone 15mg, IN

Intervention Type DRUG

Oxycodone 15mg, IN

Placebo aprepitant/ oxycodone 30 IN 0 PO

Group Type EXPERIMENTAL

Aprepitant 0mg

Intervention Type DRUG

Aprepitant 0mg, p.o. pretreatment

Oxycodone 0mg, p.o.

Intervention Type DRUG

Oxycodone 0mg, p.o.

Oxycodone 30mg, IN

Intervention Type DRUG

Oxycodone 30mg, IN

Placebo aprepitant/ oxycodone 0 IN 20 PO

Group Type EXPERIMENTAL

Aprepitant 0mg

Intervention Type DRUG

Aprepitant 0mg, p.o. pretreatment

Oxycodone 20mg, p.o.

Intervention Type DRUG

Oxycodone 20mg, p.o.

Oxycodone 0mg, IN

Intervention Type DRUG

Oxycodone 0mg, IN

Placebo aprepitant/ oxycodone 0 IN 40 PO

Group Type EXPERIMENTAL

Aprepitant 0mg

Intervention Type DRUG

Aprepitant 0mg, p.o. pretreatment

Oxycodone 40mg, p.o.

Intervention Type DRUG

Oxycodone 40mg, p.o.

Oxycodone 0mg, IN

Intervention Type DRUG

Oxycodone 0mg, IN

Aprepitant 40 mg/ oxycodone 0 IN 0 PO

Group Type EXPERIMENTAL

Aprepitant 40mg

Intervention Type DRUG

Aprepitant 40mg, p.o. pretreatment

Oxycodone 0mg, p.o.

Intervention Type DRUG

Oxycodone 0mg, p.o.

Oxycodone 0mg, IN

Intervention Type DRUG

Oxycodone 0mg, IN

Aprepitant 40 mg/ oxycodone 0 IN 20 PO

Group Type EXPERIMENTAL

Aprepitant 40mg

Intervention Type DRUG

Aprepitant 40mg, p.o. pretreatment

Oxycodone 20mg, p.o.

Intervention Type DRUG

Oxycodone 20mg, p.o.

Oxycodone 0mg, IN

Intervention Type DRUG

Oxycodone 0mg, IN

Aprepitant 40 mg/ oxycodone 0 IN 40 PO

Group Type EXPERIMENTAL

Aprepitant 40mg

Intervention Type DRUG

Aprepitant 40mg, p.o. pretreatment

Oxycodone 40mg, p.o.

Intervention Type DRUG

Oxycodone 40mg, p.o.

Oxycodone 0mg, IN

Intervention Type DRUG

Oxycodone 0mg, IN

Aprepitant 40 mg/ oxycodone 15 IN 0 PO

Group Type EXPERIMENTAL

Aprepitant 40mg

Intervention Type DRUG

Aprepitant 40mg, p.o. pretreatment

Oxycodone 0mg, p.o.

Intervention Type DRUG

Oxycodone 0mg, p.o.

Oxycodone 15mg, IN

Intervention Type DRUG

Oxycodone 15mg, IN

Aprepitant 40 mg/ oxycodone 30 IN 0 PO

Group Type EXPERIMENTAL

Aprepitant 40mg

Intervention Type DRUG

Aprepitant 40mg, p.o. pretreatment

Oxycodone 0mg, p.o.

Intervention Type DRUG

Oxycodone 0mg, p.o.

Oxycodone 30mg, IN

Intervention Type DRUG

Oxycodone 30mg, IN

Aprepitant 200 mg/ oxycodone 0 IN 0 PO

Group Type EXPERIMENTAL

Aprepitant 200mg

Intervention Type DRUG

Aprepitant 200mg, p.o. pretreatment

Oxycodone 0mg, p.o.

Intervention Type DRUG

Oxycodone 0mg, p.o.

Oxycodone 0mg, IN

Intervention Type DRUG

Oxycodone 0mg, IN

Aprepitant 200 mg/ oxycodone 0 IN 20 PO

Group Type EXPERIMENTAL

Aprepitant 200mg

Intervention Type DRUG

Aprepitant 200mg, p.o. pretreatment

Oxycodone 20mg, p.o.

Intervention Type DRUG

Oxycodone 20mg, p.o.

Oxycodone 0mg, IN

Intervention Type DRUG

Oxycodone 0mg, IN

Aprepitant 200 mg/ oxycodone 0 IN 40 PO

Group Type EXPERIMENTAL

Aprepitant 200mg

Intervention Type DRUG

Aprepitant 200mg, p.o. pretreatment

Oxycodone 40mg, p.o.

Intervention Type DRUG

Oxycodone 40mg, p.o.

Oxycodone 0mg, IN

Intervention Type DRUG

Oxycodone 0mg, IN

Aprepitant 200 mg/ oxycodone 15 IN 0 PO

Group Type EXPERIMENTAL

Aprepitant 200mg

Intervention Type DRUG

Aprepitant 200mg, p.o. pretreatment

Oxycodone 0mg, p.o.

Intervention Type DRUG

Oxycodone 0mg, p.o.

Oxycodone 15mg, IN

Intervention Type DRUG

Oxycodone 15mg, IN

Aprepitant 200 mg/ oxycodone 30 IN 0 PO

Group Type EXPERIMENTAL

Aprepitant 200mg

Intervention Type DRUG

Aprepitant 200mg, p.o. pretreatment

Oxycodone 0mg, p.o.

Intervention Type DRUG

Oxycodone 0mg, p.o.

Oxycodone 30mg, IN

Intervention Type DRUG

Oxycodone 30mg, IN

Interventions

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Aprepitant 0mg

Aprepitant 0mg, p.o. pretreatment

Intervention Type DRUG

Aprepitant 40mg

Aprepitant 40mg, p.o. pretreatment

Intervention Type DRUG

Aprepitant 200mg

Aprepitant 200mg, p.o. pretreatment

Intervention Type DRUG

Oxycodone 0mg, p.o.

Intervention Type DRUG

Oxycodone 20mg, p.o.

Intervention Type DRUG

Oxycodone 40mg, p.o.

Intervention Type DRUG

Oxycodone 0mg, IN

Intervention Type DRUG

Oxycodone 15mg, IN

Intervention Type DRUG

Oxycodone 30mg, IN

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Sharon Walsh

Director Center on Drug and Alcohol Research

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Sharon L Walsh, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

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University of Kentucky

Lexington, Kentucky, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT

PMID: 22260216 (View on PubMed)

Other Identifiers

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R01DA027031

Identifier Type: NIH

Identifier Source: secondary_id

View Link

09-0446

Identifier Type: -

Identifier Source: org_study_id

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