NCT04034004

Chronic Low Back Pain and Meditation

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain

Interventions

Type	Name	Description
BEHAVIORAL	Mindfulness	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.
DRUG	Naloxone	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.
OTHER	Saline	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.
BEHAVIORAL	Meditation	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.

Timeline

• Start date: 2021-01-01
• Primary completion: 2022-12-22
• Completion: 2022-12-22
• First posted: 2019-07-26
• Last updated: 2023-10-11
• Results posted: 2023-08-04

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study