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Aprepitant Effects on Oxycodone Response

This study has been completed.
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Sharon Walsh, University of Kentucky
ClinicalTrials.gov Identifier:
NCT00999544
First received: October 20, 2009
Last updated: August 3, 2017
Last verified: August 2017
Results First Received: November 13, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Condition: Narcotic Abuse
Interventions: Drug: Aprepitant 0mg
Drug: Aprepitant 40mg
Drug: Aprepitant 200mg
Drug: Oxycodone 0mg, p.o.
Drug: Oxycodone 20mg, p.o.
Drug: Oxycodone 40mg, p.o.
Drug: Oxycodone 0mg, IN
Drug: Oxycodone 15mg, IN
Drug: Oxycodone 30mg, IN

  Participant Flow
  Hide Participant Flow

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
  Description
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 
COMPLETED   8 
NOT COMPLETED   1 
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
  Description
Crossover Within Subject All subjects were exposed to every condition.

Baseline Measures
   Crossover Within Subject 
Overall Participants Analyzed 
[Units: Participants]
 9 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      9 100.0% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 32.3  (3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      2  22.2% 
Male      7  77.8% 
Region of Enrollment 
[Units: Participants]
 
United States   9 


  Outcome Measures
  Show All Outcome Measures

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

2.  Secondary:   Respiration Depression   [ Time Frame: 42 days ]


  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
e-mail: sharon.walsh@uky.edu


Publications of Results:

Responsible Party: Sharon Walsh, University of Kentucky
ClinicalTrials.gov Identifier: NCT00999544     History of Changes
Other Study ID Numbers: 09-0446
R01DA027031 ( U.S. NIH Grant/Contract )
Study First Received: October 20, 2009
Results First Received: November 13, 2012
Last Updated: August 3, 2017