Subjective Analgesic Effects of Naloxone and Virtual Reality

NCT ID: NCT01105871

Last Updated: 2012-08-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2014-06-30

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.

Conditions

Pain

Keywords

Pain relief

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

naloxone

4 mg in 10 ml saline iv bolus

Group Type: ACTIVE_COMPARATOR

naloxone

Intervention Type: DRUG

4 mg naloxone in 10 ml saline given iv bolus

saline placebo

10 ml of normal saline iv bolus

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

10 ml of normal saline iv bolus

Interventions

naloxone

4 mg naloxone in 10 ml saline given iv bolus

Intervention Type: DRUG

Placebo

10 ml of normal saline iv bolus

Intervention Type: DRUG

Other Intervention Names

Naloxone = Narcan

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Sam Sharar

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Samuel R Sharar, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

University of Washington Medical Center

Seattle, Washington, United States

Countries

United States

Other Identifiers

35974-D

Identifier Type: -

Identifier Source: org_study_id