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Modifying Virtual Reality Analgesia With Low-Dose Pain Medication

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ClinicalTrials.gov Identifier: NCT01840774
Recruitment Status : Unknown
Verified April 2013 by Sam Sharar, University of Washington.
Recruitment status was:  Recruiting
First Posted : April 26, 2013
Last Update Posted : April 26, 2013
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Sam Sharar, University of Washington

Brief Summary:
The purpose of this study is to determine how pain relief is modified when the investigators combine the Virtual Reality based Snow World game with certain pain medications.

Condition or disease Intervention/treatment
Virtual Reality Therapy Drug: Low-dose pain medication (Ketalar) and saline placebo

Detailed Description:
This is a randomized, double-blind, placebo-controlled, within subject 2x2 factorial, repeated measures study. Research participants will play two versions of the Virtual Reality based video game "Snow World" and be given thermal and electrical stimulus. Each of two study visits will be identical with the exception of whether or not the participant will receive an iv infusion of a low dose pain medication or a saline placebo.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Modifying Virtual Reality Analgesia With Low-Dose Pain Medication
Study Start Date : April 2013
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : June 2014

Arm Intervention/treatment
Active Comparator: Low-dose pain medication
80min IV infusion of a low-dose pain medication
Drug: Low-dose pain medication (Ketalar) and saline placebo
Placebo Comparator: saline placebo
80min IV infusion of a saline placebo
Drug: Low-dose pain medication (Ketalar) and saline placebo



Primary Outcome Measures :
  1. Pain responses between placebo and the low-dose pain medication while playing Snow World. We will assess pain responses with subjective questionnaires concerning the participant's experience while playing Snow World. [ Time Frame: Conclusion of 120 study visits. Each participant will spend a total of 8 hours with us. ]


Information from the National Library of Medicine

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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 male and females between the age of 18 and 60 years
  • Ability to communicate orally
  • Ability to read and understand English
  • Body Mass Index between 20-35

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 of migraine headaches, seizures, brain injury, or peripheral neuropathy
  • 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
  • Urine toxicology positive for opioids or benzodiazepines

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): NCT01840774


Contacts
Contact: Christine Hoffer, BA 206-616-3075 hoffer@uw.edu

Locations
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195
Contact: Christine Hoffer, BA    206-616-3075    hoffer@uw.edu   
Sponsors and Collaborators
University of Washington
National Institutes of Health (NIH)
Investigators
Principal Investigator: Samuel Sharar, MD University of Washington

Responsible Party: Sam Sharar, Study Principal Investigator, University of Washington
ClinicalTrials.gov Identifier: NCT01840774     History of Changes
Other Study ID Numbers: 43929
First Posted: April 26, 2013    Key Record Dates
Last Update Posted: April 26, 2013
Last Verified: April 2013

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