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Modifying Virtual Reality Analgesia With Low-Dose Pain Medication

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2013 by University of Washington.
Recruitment status was:  Recruiting
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Sam Sharar, University of Washington Identifier:
First received: April 8, 2013
Last updated: April 25, 2013
Last verified: April 2013
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 Intervention
Virtual Reality Therapy
Drug: Low-dose pain medication (Ketalar) and saline placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Modifying Virtual Reality Analgesia With Low-Dose Pain Medication

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • 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. ]

Estimated Enrollment: 60
Study Start Date: April 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01840774

Contact: Christine Hoffer, BA 206-616-3075

United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195
Contact: Christine Hoffer, BA    206-616-3075   
Sponsors and Collaborators
University of Washington
National Institutes of Health (NIH)
Principal Investigator: Samuel Sharar, MD University of Washington
  More Information

Responsible Party: Sam Sharar, Study Principal Investigator, University of Washington Identifier: NCT01840774     History of Changes
Other Study ID Numbers: 43929
Study First Received: April 8, 2013
Last Updated: April 25, 2013

Additional relevant MeSH terms:
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs processed this record on May 23, 2017