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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00991809
First Posted: October 8, 2009
Last Update Posted: October 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Johns Hopkins University
Results First Submitted: August 9, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, 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 Institutional Review Board (IRB) approval. Screening started on 2/9/09. The last person was screened on 3/12/2010 and finished the study in April 2010. A total of 42 screenings occurred and 12 persons completed the study. Recruitment was conducted at the Behavioral Pharmacology Research Unit (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 were 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

Subjects received 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 intramuscular(IM)

Diphenhydramine

Subjects received 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 
Overall Participants Analyzed 
[Units: Participants]
 12   10   22 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      12 100.0%      10 100.0%      22 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      0   0.0%      0   0.0% 
Male      12 100.0%      10 100.0%      22 100.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      1  10.0%      1   4.5% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      4  33.3%      4  40.0%      8  36.4% 
White      6  50.0%      5  50.0%      11  50.0% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      2  16.7%      0   0.0%      2   9.1% 
Region of Enrollment 
[Units: Participants]
     
United States   12   10   22 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Pain Tolerance   [ Time Frame: 8 sessions over 4-6 weeks ]

2.  Secondary:   Pain Threshold   [ Time Frame: 8 sessions over 4-6 weeks ]


  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.


  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: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00991809     History of Changes
Other Study ID Numbers: NA_00022154
1K24DA023186 ( U.S. NIH Grant/Contract )
First Submitted: October 7, 2009
First Posted: October 8, 2009
Results First Submitted: August 9, 2013
Results First Posted: October 14, 2013
Last Update Posted: October 6, 2017