At a glance
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The Role of Endogenous Opioids in Mindfulness-based Chronic Pain Relief
In Brief
A Early Phase 1 clinical trial evaluating Mindfulness, Naloxone, and 2 other interventions for Pain. Completed, enrolled 88 participants across 2 sites.
Detailed 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.
Study Details
Timeline
Interventions
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.