Study on the Development of Opioid Induced Hyperalgesia (OIH) After Exposure to Alfentanil (0813)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
D. Andrew Tompkins, MD, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00991809
First received: October 7, 2009
Last updated: August 9, 2013
Last verified: August 2013
Results First Received: August 9, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics/Dynamics Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Condition: Hyperalgesia
Interventions: Drug: Alfentanil
Drug: Diphenhydramine

  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
Study enrollment began in February 2009 after IRB approval was received. The first in-person study screening occurred on 2/9/09. The last person was screened on 3/12/2010 and finished the study in April 2010. A total of 42 in-person screenings occurred and 12 persons completed the study. Recruitment was conducted at the BPRU.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Since study initiation in February 2009, there has been 42 persons consented. There were 13 screen failures [4 had urines positive for illicit substances, 4 had BMI>30, 5 had active medical problems]. Seven met study criteria but decided not to start as they could not commit to study schedule (N=6) or did not like blood draws (N=1)

Reporting Groups
  Description
Alfentanil

These subjects will receive a series of acute alfentanil administrations each session (15 mcg/kg IM per session), with sessions spaced at 3-4 day intervals.

Alfentanil : 15 mcg/kg IM

Diphenhydramine

Subjects will receive a series of acute diphenhydramine administrations each session (25 mg IM per session), with sessions spaced at 3-4 day intervals.

Diphenhydramine : 25 mg IM


Participant Flow:   Overall Study
    Alfentanil     Diphenhydramine  
STARTED     12     10  
COMPLETED     8     4  
NOT COMPLETED     4     6  



  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
Alfentanil

These subjects will receive a series of acute alfentanil administrations each session (15 mcg/kg IM per session), with sessions spaced at 3-4 day intervals.

Alfentanil : 15 mcg/kg IM

Diphenhydramine

Subjects will receive a series of acute diphenhydramine administrations each session (25 mg IM per session), with sessions spaced at 3-4 day intervals.

Diphenhydramine : 25 mg IM

Total Total of all reporting groups

Baseline Measures
    Alfentanil     Diphenhydramine     Total  
Number of Participants  
[units: participants]
  12     10     22  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     12     10     22  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     0     0     0  
Male     12     10     22  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     1     1  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     4     4     8  
White     6     5     11  
More than one race     0     0     0  
Unknown or Not Reported     2     0     2  
Region of Enrollment  
[units: participants]
     
United States     12     10     22  



  Outcome Measures

1.  Primary:   Change in Pain Tolerance (Time to Hand Removal in Seconds) in the Cold Pressor Test (Mean) at the 30 Minute Time Point   [ Time Frame: 8 sessions over 4-6 weeks ]

2.  Secondary:   Change in Pain Threshold (Time to Pain Onset) of Cold Pressor Testing   [ Time Frame: 8 sessions over 4-6 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Analgesic Effects (Pain Threshold and Tolerance) on Mechanical Quantitative Sensory Testing   [ Time Frame: 8 sessions over 4-6 weeks ]
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
The sample size was intentionally small as this was to be a preliminary proof-of-concept step in the development of a human OIH model. Descriptive stats only were provided in the published manuscript.


  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. D. Andrew Tompkins
Organization: Johns Hopkins University, School of Medicine
phone: 410-550-5953
e-mail: dtompki1@jhmi.edu


Publications of Results:

Responsible Party: D. Andrew Tompkins, MD, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00991809     History of Changes
Other Study ID Numbers: 0813, 1K24DA023186
Study First Received: October 7, 2009
Results First Received: August 9, 2013
Last Updated: August 9, 2013
Health Authority: United States: Institutional Review Board