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Aprepitant Effects on Oxycodone Response

This study has been completed.
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Sharon Walsh, University of Kentucky Identifier:
First received: October 20, 2009
Last updated: July 19, 2013
Last verified: July 2013
Results First Received: November 13, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Single Group Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Condition: Narcotic Abuse
Interventions: Drug: Aprepitant
Drug: Placebo
Drug: Oxycodone

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
All recruitment was conducted through a research clinic at a public university.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were initially screened for inclusion/exclusion criteria. Fifteen subjects signed the screening consent but only nine were qualified to participate and signed the study consent. One subject left the study before receiving any interventions.

Reporting Groups
Within-subject Crossover Design All subjects received exposure to every study condition in random order. During each of 15 separate test sessions, subjects received pretreatment with aprepitant (0, 40 or 200 mg) followed by a single challenge with a oxycodone (15 or 30, intranasal; 20 or 40 mg) or placebo. The fifteen dose conditions were administered in random order and each subject was exposed to each dose combination once.

Participant Flow:   Overall Study
    Within-subject Crossover Design  
STARTED     9  
Withdrawal by Subject                 1  

  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Crossover Within Subject All subjects were exposed to every condition.

Baseline Measures
    Crossover Within Subject  
Number of Participants  
[units: participants]
[units: participants]
<=18 years     0  
Between 18 and 65 years     9  
>=65 years     0  
[units: years]
Mean ± Standard Deviation
  32.3  ± 3  
[units: participants]
Female     2  
Male     7  
Region of Enrollment  
[units: participants]
United States     9  

  Outcome Measures

1.  Primary:   Abuse Liability Proxy   [ Time Frame: 42 days ]

2.  Secondary:   Aprepitant Side Effects   [ Time Frame: 42 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No significant adverse effects occurred. No adverse events led to study drop-out.

  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Dr. Sharon Walsh
Organization: University of Kentucky
phone: 859-257-6485

Publications of Results:

Responsible Party: Sharon Walsh, University of Kentucky Identifier: NCT00999544     History of Changes
Other Study ID Numbers: 09-0446, R01DA027031
Study First Received: October 20, 2009
Results First Received: November 13, 2012
Last Updated: July 19, 2013
Health Authority: United States: Food and Drug Administration