Chronic Low Back Pain and Meditation
Condition: Pain
Study type: Interventional
Phase: Early Phase 1

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.
    

Detailed description: 
      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.
    

Intervention name(s): Mindfulness; Naloxone; Saline; Meditation
Intervention type(s): Behavioral; Drug; Other; Behavioral
Intervention description(s): A well-validated brief meditation-based mental training regimen [four sessions; 20 min/session] is used to teach patients to independently practice closing their eyes and take a deep breath every few minutes.; A 0.15 mg/kg bolus dose of naloxone (Naloxone hydrochloride, Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, California) in 25ml normal saline will be administered over 10 minutes. The investigators also will administer a supplementary IV infusion dose of 0.1mg/kg/hour naloxone immediately after bolus infusion will cease till the end of the experiment.; A 0.15 mg/kg bolus dose of saline in 25ml normal saline will be administered over 10 minutes. The investigators also will administer a supplementary IV infusion dose of 0.1mg/kg/hour saline immediately after bolus infusion will cease till the end of the experiment.; A well-validated brief meditation-based mental training regimen [four sessions; 20 min/session] is used to teach patients to independently practice closing their eyes and take a deep breath every few minutes.
Other intervention name(s): mental training; mental training
Intervention MeSH terms: Naloxone
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The study will employ a double blinded crossover factorial design. Baseline pain ratings will be assessed using visual analog scales obtained during three sessions where low back pain is induced. Study volunteers will participate in a four session (20min/session) meditation intervention. After meditation training, subjects will report to the UCSD Altman Clinical and Translational Research Institute across two separate experimental sessions. Half of the volunteers will be administered naloxone (opioid antagonist; 0.15 mg/kg bolus+ 0.1 mg/kg/hour infusion) and the other in the subsequent session will be administered IV placebo-saline, vice versa.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Mindfulness; Opioids; Pain; Naloxone