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Opioid Antagonist

naloxone for Pain (Narcan Trial)

N/A
Waitlist Available
Led By Samuel R Sharar, MD
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up outcome measurements will be assessed when all research and analysis has been completed. we project the approximate time frame to be about 18 months.
Awards & highlights

Narcan Trial Summary

This study is designed to test a specific hypothesis exploring the neurophysiologic mechanism(s) that underlie the pain- relieving effects of immersive Virtual Reality (VR) as a non-pharmacologic pain management technique, using healthy volunteers experiencing carefully controlled thermal and/or electrical pain in the laboratory. Over the past decade, our research group has performed a series of NIH-funded investigations of VR analgesia - in both the clinical pain and laboratory pain settings - demonstrating its clinical efficacy and safety. In the current study we will test pharmacologic manipulation of VR analgesia (with the opioid analgesia antagonist naloxone). We anticipate that this theoretical work will provide a foundation for future clinical applications of immersive VR - whether used alone or in combination with other analgesic agents - and make immersive VR a more effective and more widely used analgesic tool for the treatment of clinical pain. Our previous work with immersive VR indicates that its use during a painful event can reduce subjective pain reports during both acute clinical and laboratory pain by 20-50% [1]. Furthermore, we have shown that effective VR analgesia is associated with reduced pain-related brain activity that is quantitatively and qualitatively comparable to clinically relevant doses of systemic opioid analgesics [2]. The laboratory pain protocol proposed in the current application is identical to the UW HSD-approved protocol used in our previous studies (#25296 - "Reducing Brief Thermal and Electrical Pain"). What is specifically different in the current protocol is the use of naloxone to determine whether VR analgesia operates through an endogenous opioid-dependent mechanism or not. The results of this study will not only suggest the mechanism of action of VR analgesia, but also allow us to more effectively apply immersive VR analgesia in the clinically pain setting through its thoughtful combination with well-established pharmacologic analgesic techniques, such as opioid analgesia administration. The specific aim of this study and the hypothesis it tests are as follows: To determine the extent to which subjective analgesic effects of VR analgesia are inhibited by opioid receptor antagonism with naloxone. Hypothesis - VR analgesia will not be inhibited by systemic opioid receptor antagonism, suggesting that VR analgesia is not mediated by release of endogenous opiates and/or by activation of opioid-dependent descending central nervous system pathways.

Narcan Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~outcome measurements will be assessed when all research and analysis has been completed. we project the approximate time frame to be about 18 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and outcome measurements will be assessed when all research and analysis has been completed. we project the approximate time frame to be about 18 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pain scoring from sessions where naloxone is given or placebo.Pain scoring is a questionnaire using analog scale (1-10).

Narcan Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: naloxoneActive Control1 Intervention
4 mg in 10 ml saline iv bolus
Group II: saline placeboPlacebo Group1 Intervention
10 ml of normal saline iv bolus

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Who is running the clinical trial?

University of WashingtonLead Sponsor
1,740 Previous Clinical Trials
1,847,620 Total Patients Enrolled
24 Trials studying Pain
13,717 Patients Enrolled for Pain
Samuel R Sharar, MDPrincipal InvestigatorUniversity of Washington
1 Previous Clinical Trials
180 Total Patients Enrolled
1 Trials studying Pain
180 Patients Enrolled for Pain

Frequently Asked Questions

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~3 spots leftby Apr 2025