Study Results
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View full resultsBasic Information
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COMPLETED
EARLY_PHASE1
88 participants
INTERVENTIONAL
2021-01-01
2022-12-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
TRIPLE
Study Groups
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Meditation
Subjects will participate in four sessions (20 min/session) of mindfulness training. Participants will be taught that perceived sensory events are "momentary" and "fleeting" and require no further evaluation.
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.
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.
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.
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.
meditation
Subjects will participate in four sessions (20 min/session) of mindfulness training. Participants will be taught that perceived sensory events are "momentary" and "fleeting" and require no further evaluation.
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.
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.
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.
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.
Interventions
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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.
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.
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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National Center for Complementary and Integrative Health (NCCIH)
NIH
University of California, San Diego
OTHER
Responsible Party
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Fadel Zeidan
Assistant Professor
Principal Investigators
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Fadel Zeidan, PhD
Role: PRINCIPAL_INVESTIGATOR
UC San Diego
Locations
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Altman Clinical and Translational Research Institute
La Jolla, California, United States
UC San Diego Center for Mindfulness
San Diego, California, United States
Countries
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References
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Khatib L, Dean JG, Oliva V, Riegner G, Gonzalez NE, Birenbaum J, Cruanes GF, Miller J, Patterson M, Kim HC, Chakravarthy K, Zeidan F. The role of endogenous opioids in mindfulness and sham mindfulness-meditation for the direct alleviation of evoked chronic low back pain: a randomized clinical trial. Neuropsychopharmacology. 2024 Jun;49(7):1069-1077. doi: 10.1038/s41386-023-01766-2. Epub 2023 Nov 20.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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190709
Identifier Type: -
Identifier Source: org_study_id
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