Opiate-Induced Tolerance & Hyperalgesia in Pain Patients
Completed · Phase 4 · Has a placebo group
Conditions studied: Chronic Low Back Pain, Opioid-induced Hyperalgesia
In brief
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.
Key facts
- Study ID
- NCT00246532
- Run by
- National Institute of General Medical Sciences (NIGMS)
- People needed
- 139
- Starts
- 2005-10-01
- Expected to finish
- 2009-08-01
- Last updated by the study team
- 2012-04-30
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- opioid naïve (or less than 4 vicodin equiv/day)
- 18-70 years old
- candidate for opioid therapy for nonmalignant pain.
You may not qualify if…
- history of substance abuse or severe psychiatric disease
- use of medications for the treatment of neuropathic pain as these may alter tolerance or hyperalgesia
- neurological conditions interfering with experimental pain testing, e.g. severe peripheral neuropathy
Where it is running
- Stanford University School of Medicine — Stanford, California, United States
Full record on ClinicalTrials.gov
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