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

Condition(s) targeted: Hyperalgesia

Intervention: Alfentanil (Drug); Diphenhydramine (Drug)

Phase: N/A

Status: Completed

Sponsored by: Johns Hopkins University

Official(s) and/or principal investigator(s):
David A Tompkins, M.D., Principal Investigator, Affiliation: Johns Hopkins University

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.

Official title: A Pilot Study of Prolonged, Intermittent Exposure to Alfentanil on Opioid-Induced Hyperalgesia in Healthy Volunteers

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Primary outcome: Change in Pain Tolerance (Time to Hand Removal in Seconds) in the Cold Pressor Test (Mean) at the 30 Minute Time Point

Secondary outcome:

Change in Pain Threshold (Time to Pain Onset) of Cold Pressor Testing

Analgesic Effects (Pain Threshold and Tolerance) on Mechanical Quantitative Sensory Testing

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 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.

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Male.

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

Behavioral Pharmacology Research Unit, Baltimore, Maryland 21224, United States

Starting date: February 2009
Last updated: August 9, 2013