Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00256347
Status:
COMPLETED
Last Update Posted:
2011-04-14
First Post:
2005-11-16
Brief Title:
Analgesic Tolerance to Repeated Doses of Subcutaneous Morphine
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Development of Analgesic Tolerance to Repeated Doses of Subcutaneous Morphine Using the Brief Thermal Sensitization Model in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2011-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
30 healthy volunteers will be enrolled in this 6-session study The first visit will be a screeningorientation 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
Detailed Description:
30 healthy volunteers will be enrolled in this 6-session study The first visit will be a screeningorientation 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 C1130 F on the thigh for 3 minutes Brief Thermal Sensitization model
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| H5612-25135 | None | None | None |