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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00991809
First Posted: October 8, 2009
Last Update Posted: October 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Johns Hopkins University
  Purpose
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.

Condition Intervention
Hyperalgesia Drug: Alfentanil Drug: Diphenhydramine

Study Type: Interventional
Study Design: Allocation: Randomized
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

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


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
Subjects received 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 received 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 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

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


Locations
United States, Maryland
Behavioral Pharmacology Research Unit
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: David A Tompkins, M.D. Johns Hopkins University
  More Information

Additional Information:
Publications:
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00991809     History of Changes
Other Study ID Numbers: NA_00022154
1K24DA023186 ( U.S. NIH Grant/Contract )
First Submitted: October 7, 2009
First Posted: October 8, 2009
Results First Submitted: August 9, 2013
Results First Posted: October 14, 2013
Last Update Posted: October 6, 2017
Last Verified: September 2017

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
Analgesics, Opioid
Alfentanil
Diphenhydramine
Promethazine
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Local
Anesthetics
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
Anti-Allergic Agents
Antipruritics
Dermatologic Agents