Study on the Development of Opioid Induced Hyperalgesia (OIH) After Exposure to Alfentanil (0813)
The purpose of this study is to follow a person's response to experimental pain after multiple consecutive exposures to alfentanil or diphenhydramine to see if the person can tolerate the pain more, less, or the same at the end of the study.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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|
- 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 ] [ Designated as safety issue: No ]
- Change in Pain Threshold (Time to Pain Onset) of Cold Pressor Testing [ Time Frame: 8 sessions over 4-6 weeks ] [ Designated as safety issue: No ]
- Analgesic Effects (Pain Threshold and Tolerance) on Mechanical Quantitative Sensory Testing [ Time Frame: 8 sessions over 4-6 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||February 2009|
|Study Completion Date:||May 2010|
|Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
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.
15 mcg/kg IM
Active Comparator: 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.
25 mg IM
Other Name: Benadryl
This project investigates the phenomenon of opioid-induced hyperalgesia (OIH). Opioid analgesics, in addition to their therapeutic anti-nociceptive effects, under some conditions produce pro-nociceptive effects. This phenomenon of pain or pain sensitivity being increased by prior opioid administration is called opioid-induced hyperalgesia. It is thought to be relevant both to pain management complications and to complications of opioid dependence and its treatment. This study investigates the time-course of opioid-induced hyperalgesia development in healthy normal volunteers (N=12 completers), using a series of acute alfentanil administrations (15 mg/kg mg IM per day) spaced at 3-4 day intervals, with testing for pain tolerance using the cold pressor test (CPT), and mechanical quantitative sensory testing (MQST) each administered repeatedly over time within each testing day. The goal is to determine the time course of OIH development following acute opioid administration, and to assess whether this changes over repeated acute opioid administrations.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00991809
|United States, Maryland|
|Behavioral Pharmacology Research Unit|
|Baltimore, Maryland, United States, 21224|
|Principal Investigator:||David A Tompkins, M.D.||Johns Hopkins University|