Aprepitant Effects on Oxycodone Response

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.

Conditions

• Narcotic Abuse

Interventions

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

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• Merck Sharp & Dohme LLC

  collaborator INDUSTRY

• Sharon Walsh

  lead OTHER

Principal Investigators

• Sharon L Walsh, Ph.D. · University of Kentucky

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2009-10-31

Primary Completion

2011-04-30

Completion

2011-04-30

Countries

• United States

Study Locations