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Completed

NCT Number: NCT00991809

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

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.

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Key information

Conditions

Hyperalgesia Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Somatosensory Disorders

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Behavioral Pharmacology Research Unit

Baltimore, Maryland, 21224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

alfentanil

Drug

15 mcg/kg IM

diphenhydramine

Drug

25 mg IM

Other names: Benadryl

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Acronym: 0813

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 8, 2009
Registry last updated
Oct 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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