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Subjective Analgesic Effects of Naloxone and Virtual Reality (Narcan)

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ClinicalTrials.gov Identifier: NCT01105871
Recruitment Status : Unknown
Verified August 2012 by Sam Sharar, University of Washington.
Recruitment status was:  Active, not recruiting
First Posted : April 19, 2010
Last Update Posted : August 21, 2012
Sponsor:
Information provided by (Responsible Party):
Sam Sharar, University of Washington

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 Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated 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 : August 2010
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: Naloxone = Narcan
Placebo Comparator: saline placebo
10 ml of normal saline iv bolus
Drug: Placebo
10 ml of normal saline iv bolus



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


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01105871


Locations
United States, Washington
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

Responsible Party: Sam Sharar, Principal Investigator, University of Washington
ClinicalTrials.gov Identifier: NCT01105871     History of Changes
Other Study ID Numbers: 35974-D
First Posted: April 19, 2010    Key Record Dates
Last Update Posted: August 21, 2012
Last Verified: August 2012

Keywords provided by Sam Sharar, University of Washington:
Pain relief

Additional relevant MeSH terms:
Analgesics
Naloxone
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Narcotic Antagonists