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| Sponsored by: |
National Institute of General Medical Sciences (NIGMS) |
|---|---|
| Information provided by: | National Institute of General Medical Sciences (NIGMS) |
| ClinicalTrials.gov Identifier: | NCT00246532 |
Purpose
Opiates such as morphine are the cornerstone medications for the treatment of moderate to severe pain. Recent evidence suggests that pain patients on chronic opioid therapy become more sensitive to pain (hyperalgesia) over time. There is also a long-standing notion that analgesic tolerance to opioids (habituation) develops during chronic use even though this phenomenon has never been prospectively studied. Our specific aims propose to prospectively test the hypotheses that; 1) Pain patients on chronic opioid therapy develop dose-dependent tolerance and/or hyperalgesia to these medications over time, 2) Opioid-induced tolerance and hyperalgesia develop differently with respect to various types of pain, 3) Opioid-induced hyperalgesia occurs independently of withdrawal phenomena, and 4) Opioid-induced tolerance and hyperalgesia develop differently based on gender and/or ethnicity. This proposed study will be the first quantitative and prospective study of tolerance and hyperalgesia in pain patients and will have important implications for the rational use of opioids in the treatment of chronic pain.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Low Back Pain Opioid-Induced Hyperalgesia |
Drug: Morphine Drug: Placebo |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Randomized, Double Blind (Subject, Investigator), Parallel Assignment |
| Official Title: | Opiate-Induced Tolerance & Hyperalgesia in Pain Patients |
| Estimated Enrollment: | 160 |
| Study Start Date: | October 2005 |
| Estimated Study Completion Date: | August 2009 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Placebo Pill: Placebo Comparator
This arm contains placebo medication.
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Drug: Placebo
Patients will receive placebo tablets.
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2: Morphine: Active Comparator
Patients will receive oral morphine therapy.
|
Drug: Morphine
Patients will be given morphine sulfate oral medication until their back pain is adequately controlled.
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Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| Stanford University School of Medicine | Recruiting |
| Stanford, California, United States, 94025 | |
| Contact: Lawrence F Chu, MD, MS 650-723-6411 stanfordbackpain@gmail.com | |
| Principal Investigator: Lawrence F Chu, MD, MS | |
| Principal Investigator: | Lawrence F Chu, MD, MS | Stanford University |
More Information
| Responsible Party: | Stanford University ( Sonia Barragan ) |
| Study ID Numbers: | 5K23GM071400-02, 5K23GM071400-02 |
| Study First Received: | October 26, 2005 |
| Last Updated: | October 2, 2008 |
| ClinicalTrials.gov Identifier: | NCT00246532 History of Changes |
| Health Authority: | United States: Federal Government |
|
Sensation Disorders Morphine Low Back Pain Central Nervous System Depressants Narcotics Pain Back Pain |
Hyperalgesia Somatosensory Disorders Signs and Symptoms Neurologic Manifestations Analgesics Peripheral Nervous System Agents Analgesics, Opioid |
|
Sensation Disorders Morphine Physiological Effects of Drugs Nervous System Diseases Central Nervous System Depressants Low Back Pain Narcotics Pain Hyperalgesia Back Pain |
Pharmacologic Actions Somatosensory Disorders Signs and Symptoms Sensory System Agents Therapeutic Uses Neurologic Manifestations Peripheral Nervous System Agents Analgesics Central Nervous System Agents Analgesics, Opioid |
