Narcan: Subjective Analgesic Effects of Naloxone and Virtual Reality

Sponsor

University of Washington (Other)

Overall Status

Unknown status

CT.gov ID

NCT01105871

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pain	Drug: naloxone Drug: Placebo	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Supportive Care

Official Title:

Subjective Analgesic Effects of Naloxone and Virtual Reality

Study Start Date :

Aug 1, 2010

Anticipated Primary Completion Date :

Jun 1, 2014

Anticipated Study Completion Date :

Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: naloxone 4 mg in 10 ml saline iv bolus	Drug: naloxone 4 mg naloxone in 10 ml saline given iv bolus Other Names: Naloxone = Narcan
Placebo Comparator: saline placebo 10 ml of normal saline iv bolus	Drug: Placebo 10 ml of normal saline iv bolus

Arm

Intervention/Treatment

Active Comparator: naloxone

4 mg in 10 ml saline iv bolus

Drug: naloxone

4 mg naloxone in 10 ml saline given iv bolus

Other Names:

Naloxone = Narcan

Placebo Comparator: saline placebo

10 ml of normal saline iv bolus

Drug: Placebo

10 ml of normal saline iv bolus

Outcome Measures

Primary Outcome Measures

Pain scoring from sessions where naloxone is given or placebo.Pain scoring is a questionnaire using analog scale (1-10). [Outcome measurements will be assessed when all research and analysis has been completed. We project the approximate time frame to be about 18 months.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy males and females between the ages of 18 and 60 years
Ability to communicate orally
Body mass index of 30 or less

Exclusion Criteria:

Women who are pregnant, trying to become pregnant or who are breastfeeding.
History of alcohol or substance abuse
Major medical illness, including history or migraine headaches
Allergy or sensitivity to narcotics or naloxone
Current use of analgesics including acetaminophen, non-steroidal anti-inflammatories, or opioids
Predisposition to severe motion sickness
Unusual sensitivity or lack of sensitivity to pain
Sensitive skin
Urine toxicology positive for opioids

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Washington Medical Center	Seattle	Washington	United States	98195

Sponsors and Collaborators

University of Washington

Investigators

Principal Investigator: Samuel R Sharar, MD, University of Washington

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sam Sharar, Principal Investigator, University of Washington

ClinicalTrials.gov Identifier:

NCT01105871

Other Study ID Numbers:

35974-D

First Posted:

Apr 19, 2010

Last Update Posted:

Aug 21, 2012

Last Verified:

Aug 1, 2012

Keywords provided by Sam Sharar, Principal Investigator, University of Washington

Pain relief

Additional relevant MeSH terms:

Naloxone

Study Results

No Results Posted as of Aug 21, 2012