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The Role of Opioidergic Systems in Breathing Based Analgesia

NCT03419858 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-06-11

No results posted yet for this study

Summary

The purpose of this psychophysical and pharmacologic study is to determine if slow-breathing induced pain relief is mediated by endogenous opioids in response to intravenous (IV) administration of the opioid antagonist naloxone during noxious heat stimulation. We were also interested in disentangling the endogenous analgesic mechanisms supporting mindfulness-based analgesia.

Conditions

Interventions

BEHAVIORAL

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.

BEHAVIORAL

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.

BEHAVIORAL

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.

DRUG

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.

OTHER

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.

Sponsors & Collaborators

Principal Investigators

  • Fadel Zeidan, PhD · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-13
Primary Completion
2017-06-27
Completion
2017-06-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03419858 on ClinicalTrials.gov