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| Sponsor: | University of California, San Francisco |
|---|---|
| Information provided by: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT00275249 |
Purpose
The purpose of this study is to determine the extent to which analgesic tolerance develops in chronic pain patients who are either started on opioids or who receive an increase in pre-study opioid dose level and then observed during long-term (20 weeks) stable opioid therapy. In addition to clinical measures of relief of ongoing chronic pain, estimation of tolerance development will be supplemented by periodic assessment of the anti-nociceptive effects of opioids using the brief thermal sensitization model.
| Condition | Intervention |
|---|---|
|
Chronic Pain |
Drug: levorphanol |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind |
| Official Title: | Evolution of Analgesic Tolerance During Long Term Treatment of Chronic Pain With Opioids |
| Estimated Enrollment: | 60 |
| Study Start Date: | March 2001 |
| Study Completion Date: | December 2005 |
| Primary Completion Date: | October 2004 (Final data collection date for primary outcome measure) |
The purpose of this study is to determine the extent to which analgesic tolerance develops in chronic pain patients who are either started on opioids or who receive an increase in pre-study opioid dose level and then observed during long-term (20 weeks) stable opioid therapy. In addition to clinical measures of relief of ongoing chronic pain, estimation of tolerance development will be supplemented by periodic assessment of the anti-nociceptive effects of opioids using the brief thermal sensitization model.
Eligibility| Ages Eligible for Study: | 21 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| UCSF Pain Clinical Research Center | |
| San Francisco, California, United States, 94115 | |
| Principal Investigator: | Michael Rowbotham, MD | University of California, San Francisco |
More Information
| ClinicalTrials.gov Identifier: | NCT00275249 History of Changes |
| Other Study ID Numbers: | H5612-23841 |
| Study First Received: | January 9, 2006 |
| Last Updated: | April 12, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Chronic Pain |
|
Levorphanol Analgesics, Opioid Analgesics Narcotics Central Nervous System Depressants Physiological Effects of Drugs |
Pharmacologic Actions Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses |