Study on the Development of Opioid Induced Hyperalgesia (OIH) After Exposure to Alfentanil (0813)
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|ClinicalTrials.gov Identifier: NCT00991809|
Recruitment Status : Completed
First Posted : October 8, 2009
Results First Posted : October 14, 2013
Last Update Posted : October 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hyperalgesia||Drug: Alfentanil Drug: Diphenhydramine||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||A Pilot Study of Prolonged, Intermittent Exposure to Alfentanil on Opioid-Induced Hyperalgesia in Healthy Volunteers|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||May 2010|
|Actual Study Completion Date :||May 2010|
Subjects received a series of acute alfentanil administrations each session (15 mcg/kg IM per session), with sessions spaced at 3-4 day intervals.
15 mcg/kg IM
Active Comparator: Diphenhydramine
Subjects received a series of acute diphenhydramine administrations each session (25 mg IM per session), with sessions spaced at 3-4 day intervals.
25 mg IM
Other Name: Benadryl
- Pain Tolerance [ Time Frame: 8 sessions over 4-6 weeks ]The participant places their hand in a water bath kept at 4 degrees Celsius (cold pressor test). They then continue to hold the hand in the water bath until they can no longer tolerate the pain (pain tolerance) or until the end of the testing (truncated at 300 seconds for safety purposes). Reported as the mean (time to hand removal in seconds) at the 30 minute time point.
- Pain Threshold [ Time Frame: 8 sessions over 4-6 weeks ]The amount of time (in seconds) before the participant first verbally reports feeling pain after placing hand in 4 degree Celsius circulating water bath at the 30 minute time point. Truncated at 300 seconds for safety purposes.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00991809
|United States, Maryland|
|Behavioral Pharmacology Research Unit|
|Baltimore, Maryland, United States, 21224|
|Principal Investigator:||David A Tompkins, M.D.||Johns Hopkins University|