NCT00246532

Opiate-Induced Tolerance & Hyperalgesia in Pain Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 139 (actual)
• Sponsor: National Institute of General Medical Sciences (NIGMS) · NIH
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Chronic Low Back Pain
• Opioid-induced Hyperalgesia

Interventions

Type	Name	Description
DRUG	Morphine	Patients will be given morphine sulfate oral medication until their back pain is adequately controlled.
DRUG	Placebo	Patients will receive placebo tablets.

Timeline

• Start date: 2005-10-01
• Primary completion: 2008-12-01
• Completion: 2009-08-01
• First posted: 2005-10-31
• Last updated: 2012-04-30

Locations

1 site across 1 country: United States