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New Neural Drug Targets

This study has been completed.
Sponsor:
Collaborator:
Merck
Information provided by (Responsible Party):
Sharon Walsh, University of Kentucky
ClinicalTrials.gov Identifier:
NCT00999544
First received: October 20, 2009
Last updated: September 5, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention
Narcotic Abuse
 Drug: Aprepitant
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: New Neural Drug Targets: An Evaluation of the Effects of Aprepitant on the Response to Oxycodone

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Kentucky:

Primary Outcome Measures:
  • Opioid Abuse Liability [ Time Frame: 42 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Aprepitant Side Effects [ Time Frame: 42 days ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: October 2009
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aprepitant
This is a full crossover study in which all participants will receive every planned study drug condition.
 Drug: Aprepitant
Aprepitant (0, 40, 200 mg, p.o.) to be given in combination with a range of oxycodone doses (p.o., i.n.)
Other Name: Emend
Experimental: Placebo
This is a full crossover study in which all participants will receive every planned study drug condition.
 Drug: Placebo
placebo condition

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00999544

Locations
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40502
Sponsors and Collaborators
University of Kentucky
Merck
Investigators
Principal Investigator: Sharon L Walsh, Ph.D. University of Kentucky
  More Information

No publications provided by University of Kentucky

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Sharon Walsh, Director Center on Drug and Alcohol Research, University of Kentucky
ClinicalTrials.gov Identifier: NCT00999544     History of Changes
Other Study ID Numbers: 09-0446, R01DA027031
Study First Received: October 20, 2009
Last Updated: September 5, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Kentucky:
opioid
oxycodone
NK1 antagonist
 aprepitant
intranasal
abuse

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Mental Disorders
Oxycodone
Aprepitant
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid
Antiemetics
Autonomic Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 23, 2013