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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
D. Andrew Tompkins, MD, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00991809
First received: October 7, 2009
Last updated: August 9, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Hyperalgesia
Drug: Alfentanil
Drug: Diphenhydramine

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 22
Study Start Date: February 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: Alfentanil
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.
Drug: Diphenhydramine
25 mg IM
Other Name: Benadryl

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00991809

Locations
United States, Maryland
Behavioral Pharmacology Research Unit
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: David A Tompkins, M.D. Johns Hopkins University
  More Information

Additional Information:
Publications:
Responsible Party: D. Andrew Tompkins, MD, Assistant Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00991809     History of Changes
Other Study ID Numbers: 0813, 1K24DA023186
Study First Received: October 7, 2009
Results First Received: August 9, 2013
Last Updated: August 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
opioid induced hyperalgesia

Additional relevant MeSH terms:
Hyperalgesia
Somatosensory Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Alfentanil
Analgesics, Opioid
Diphenhydramine
Promethazine
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anesthetics, Local
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on August 21, 2014