Chronic Low Back Pain and Meditation

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.

Conditions

• Pain

Interventions

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.

Sponsors & Collaborators

• National Center for Complementary and Integrative Health (NCCIH)

  collaborator NIH

• University of California, San Diego

  lead OTHER

Principal Investigators

• Fadel Zeidan, PhD · UC San Diego

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-01-01

Primary Completion

2022-12-22

Completion

2022-12-22

FDA Drug

Yes

Countries

• United States

Study Locations