Clinical trial NCT00991809: Study on the Development of Opioid Induced Hyperalgesia (OIH) After Exposure to Alfentanil
Official title: A Pilot Study of Prolonged, Intermittent Exposure to Alfentanil on Opioid-Induced Hyperalgesia in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperalgesia
Keywords: opioid induced hyperalgesia
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2009-10-08
Enrollment: 22
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study was 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.

Detailed description: 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 investigated 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 intramuscular (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 was to determine the time course of OIH development following acute opioid administration, and to assess whether this changes over repeated acute opioid administrations.

Eligibility criteria: Inclusion Criteria:

* Age 18-55
* No active medical conditions
* BMI between 20-30
* Able and willing to perform/tolerate pain procedures
* Able to communicate in English

Exclusion Criteria:

* Lifetime substance use disorder, except for alcohol abuse/dependence in remission
* Use of opiates in last 3 months
* Ongoing marijuana use
* Acute or chronic pain
* Neurologic or psychiatric condition known to influence cold pressor testing (peripheral neuropathy, major depression, or schizophrenia)
* Current use of prescribed or over the counter pain medications
* Previous adverse reaction to opiate medications or diphenhydramine
* Use of tobacco or caffeine on study days

Primary outcomes:
measure: Pain Tolerance
timeFrame: 8 sessions over 4-6 weeks
Secondary outcomes:
measure: Pain Threshold
timeFrame: 8 sessions over 4-6 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Behavioral Pharmacology Research Unit
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: David A Tompkins, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tompkins DA, Smith MT, Bigelow GE, Moaddel R, Venkata SL, Strain EC. The effect of repeated intramuscular alfentanil injections on experimental pain and abuse liability indices in healthy males. Clin J Pain. 2014 Jan;30(1):36-45. doi: 10.1097/AJP.0b013e3182851758.