Summary

for people ages 18-65 (full criteria)
at San Diego, California and other locations
study started
estimated completion
Fadel Zeidan, PhD

Description

Summary

The purpose of this research study is to see if and how mindfulness meditation affects pain. Specifically, we are interested in assessing if mindfulness is associated with the release of naturally occurring opiates in the body, in response to intravenous (IV) administration of the opioid antagonist naloxone during a chronic low back pain provoking procedure.

Official Title

The Role of Endogenous Opioids in Mindfulness-based Chronic Pain Relief

Details

The purpose of this psychophysical and pharmacologic study is to determine if meditation induced pain relief is mediated by endogenous opioids in response to intravenous (IV) administration of the opioid antagonist naloxone during a pain evoking straight leg raise test in response to double-blind intravenous administration (IV) of naloxone/placebo-saline. The aim of this study is to determine if mindfulness-based analgesia is associated with the release of endogenous opioids.

Keywords

Pain Mindfulness Opioids Naloxone Analgesics, Opioid Endorphins Saline Meditation

Eligibility

You can join if…

Open to people ages 18-65

  • Participants must have a medical evaluation that demonstrates chronic low back pain that is evoked by lifting the legs. Existing medical records, per physician discretion and low back examinations will confirm diagnosis
  • Participants must be between 18 and 65 years of age
  • Participants must rate their daily chronic pain intensity at a 3 or higher on 0-10 visual analog scale
  • Participants must have experienced their chronic low back pain for at least 3 months
  • Participants must have no prior meditative experience
  • Participants must be straight leg raise test positive

You CAN'T join if...

  • Participants must not be participating in any new (within 2 weeks prior or anytime after enrollment) pain management procedures during the study period
  • Participants must not be taking opioids
  • Participants must not be pregnant or nursing mothers
  • Participants must have not had back surgery within the last year before their enrollment into the study
  • Participants must have not had any other sensory or motor deficits that preclude participation in this study
  • Participants must not have known anomalies of the central nervous system including: stroke, dementia, aneurysm, and a personal history of psychosis
  • Participants must not have any known allergies to naloxone or similar drugs
  • Participants must not have a history of syncope and/or fear of needles/blood

Locations

  • UC San Diego Center for Mindfulness accepting new patients
    San Diego California 92122 United States
  • Altman Clinical and Translational Research Institute accepting new patients
    La Jolla California 92093 United States

Lead Scientist

  • Fadel Zeidan, PhD
    Assistant Professor, Anesthesiology. Authored (or co-authored) 26 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT04034004
Phase
Phase 1
Study Type
Interventional
Last Updated