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Sponsored by: |
University of California, San Francisco |
Information provided by: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT00256347 |
30 healthy volunteers will be enrolled in this 6-session study. The first visit will be a screening/orientation session. The next 5 visits will be (full day) outpatient sessions taking place Monday through Friday during one week. All full day visits will be drug administration sessions with subjects randomized to one of two groups. The primary purpose is to investigate the time course of development of analgesic tolerance (loss of pain relieving effect) to morphine on experimentally produced skin tenderness in healthy volunteers.
Condition | Intervention |
Healthy Volunteers |
Drug: intramuscular injections of morphine |
Study Type: | Interventional |
Study Design: | Randomized, Double-Blind, Placebo Control, Crossover Assignment |
Official Title: | Development of Analgesic Tolerance to Repeated Doses of Subcutaneous Morphine Using the Brief Thermal Sensitization Model in Healthy Volunteers |
Estimated Enrollment: | 30 |
Study Start Date: | March 2005 |
30 healthy volunteers will be enrolled in this 6-session study. The first visit will be a screening/orientation session. The next 5 visits will be (full day) outpatient sessions taking place Monday through Friday during one week. All full day visits will be drug administration sessions with subjects randomized to one of two groups. Group A will receive two daily intramuscular injections of 8 mg morphine on Monday through Thursday and two intramuscular injections of placebo on Friday. Group B will receive two daily intramuscular injections of placebo on Monday through Thursday and two intramuscular injections of 8 mg morphine on Friday. During the Monday through Friday sessions the painfulness of experimental heat application and the area of skin tenderness (primary and secondary hyperalgesia) will be assessed before and two times after the intramuscular injections. Heat will be applied by using a computer controlled probe that applies heat (450 C/1130 F) on the thigh for 3 minutes (Brief Thermal Sensitization model.)
Ages Eligible for Study: | 21 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |||||
UCSF | |||||
San Francisco, California, United States, 94115 |
University of California, San Francisco |
Principal Investigator: | Karin Petersen, MD | University of California, San Francisco |
Principal Investigator: | Michael C Rowbotham, MD | University of California, San Francisco |
Study ID Numbers: | H5612-25135, H5612-25135 |
First Received: | November 16, 2005 |
Last Updated: | January 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00256347 |
Health Authority: | United States: Institutional Review Board |
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