The Role of Opioidergic Systems in Breathing Based Analgesia
NCT ID: NCT03419858
Last Updated: 2019-06-11
Study Results
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Basic Information
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COMPLETED
EARLY_PHASE1
60 participants
INTERVENTIONAL
2017-03-13
2017-06-27
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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Mindfulness Meditation Group
Subjects participated in four sessions (20 min/session) of mindfulness training. Participants were taught that perceived sensory events are "momentary" and "fleeting" and require no further evaluation. They were asked to close their eyes, relax and to focus on the flow of their breathing and "simply let go" of discursive thoughts.
Mindfulness Meditation
A well-validated brief mindfulness-based mental training regimen \[four sessions; 20 min/session\] was used to teach patients to independently practice mindfulness meditation.
Naloxone
A 0.15 mg/kg bolus dose of naloxone (Naloxone Hydrichloride, Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, California) in 25ml normal saline was administered over 10 minutes. We also administered a supplementary IV infusion dose of 0.1mg/kg/hour naloxone immediately after bolus infusion ceased till the end of the experiment.
Saline
A 0.15 mg/kg bolus dose of saline in 25ml normal saline was administered over 10 minutes. We also administered a supplementary IV infusion dose of 0.1mg/kg/hour saline immediately after bolus infusion ceased till the end of the experiment.
Placebo Meditation Group
The purpose of this intervention was to lead subjects to attend to one's breathing in a non-evaluative manner. Subjects were instructed to sit with a straight posture, closed eyes, and to take a deep, slow breaths every 2-3 minutes.
Placebo Meditation
A well-validated brief meditation-based mental training regimen \[four sessions; 20 min/session\] was 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 Hydrichloride, Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, California) in 25ml normal saline was administered over 10 minutes. We also administered a supplementary IV infusion dose of 0.1mg/kg/hour naloxone immediately after bolus infusion ceased till the end of the experiment.
Saline
A 0.15 mg/kg bolus dose of saline in 25ml normal saline was administered over 10 minutes. We also administered a supplementary IV infusion dose of 0.1mg/kg/hour saline immediately after bolus infusion ceased till the end of the experiment.
Slow-Breathing Group
A validated (Chalaye et al., 2009) slow breathing training regimen was employed, using fluctuating light, to teach individuals to independently lower their respective respiration rate. Subjects practiced lowering their respiration rates across four, 20 minute sessions.
Slow-Breathing
Study volunteers practiced lowering their breathing rate, across four, 20 minute training sessions, in response to a fluctuating light with the guidance of a trained facilitator.
Naloxone
A 0.15 mg/kg bolus dose of naloxone (Naloxone Hydrichloride, Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, California) in 25ml normal saline was administered over 10 minutes. We also administered a supplementary IV infusion dose of 0.1mg/kg/hour naloxone immediately after bolus infusion ceased till the end of the experiment.
Saline
A 0.15 mg/kg bolus dose of saline in 25ml normal saline was administered over 10 minutes. We also administered a supplementary IV infusion dose of 0.1mg/kg/hour saline immediately after bolus infusion ceased till the end of the experiment.
Interventions
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Mindfulness Meditation
A well-validated brief mindfulness-based mental training regimen \[four sessions; 20 min/session\] was used to teach patients to independently practice mindfulness meditation.
Placebo Meditation
A well-validated brief meditation-based mental training regimen \[four sessions; 20 min/session\] was used to teach patients to independently practice closing their eyes and take a deep breath every few minutes.
Slow-Breathing
Study volunteers practiced lowering their breathing rate, across four, 20 minute training sessions, in response to a fluctuating light with the guidance of a trained facilitator.
Naloxone
A 0.15 mg/kg bolus dose of naloxone (Naloxone Hydrichloride, Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, California) in 25ml normal saline was administered over 10 minutes. We also administered a supplementary IV infusion dose of 0.1mg/kg/hour naloxone immediately after bolus infusion ceased till the end of the experiment.
Saline
A 0.15 mg/kg bolus dose of saline in 25ml normal saline was administered over 10 minutes. We also administered a supplementary IV infusion dose of 0.1mg/kg/hour saline immediately after bolus infusion ceased till the end of the experiment.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Volunteers had no prior meditation experience
* Volunteers could be male and non-pregnant females.
* Volunteers of all ethnic backgrounds were included.
Exclusion Criteria
* They could not be taking opioids or antidepressants.
* Subjects with a repeated history of syncope, loss of consciousness, light headedness, nausea, dizziness, or vomiting in response to needles or blood could not participate in the study.
* Subject could not be using exogenous opiates for the complete duration of the study.
18 Years
55 Years
ALL
Yes
Sponsors
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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
Wake Forest University Health Sciences
Locations
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Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Countries
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References
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Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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IRB00040519
Identifier Type: -
Identifier Source: org_study_id
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