Opiate-Induced Tolerance & Hyperalgesia in Pain Patients

Chronic Low Back Pain Clinical Trial

Official title:

Opiate-Induced Tolerance & Hyperalgesia in Pain Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00246532
• Other study ID #: 5K23GM071400-02
• Secondary ID: 5K23GM071400-02
• Status: Completed
• Phase: Phase 4
• First received: October 26, 2005
• Last updated: April 26, 2012
• Start date: October 2005
• Est. completion date: August 2009

Study information

• Verified date: April 2012
• Source: National Institute of General Medical Sciences (NIGMS)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: August 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• opioid naïve (or less than 4 vicodin equiv/day)

• 18-70 years old

• candidate for opioid therapy for nonmalignant pain.

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Chronic Low Back Pain
• Hyperalgesia
• Low Back Pain
• Opioid-induced Hyperalgesia

Intervention

Drug:
• Morphine
Patients will be given morphine sulfate oral medication until their back pain is adequately controlled.
• Placebo
Patients will receive placebo tablets.

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Tolerance		1 month	No
Primary	Pain Threshold		1 month	No
Secondary	Opioid Titration		1 month	No
Secondary	Pain Intensity		1 month	No
Secondary	Roland-Morris Disability Index		1 month	No
Secondary	Beck Depression Inventory		1 month	No
Secondary	Follow-Up Survey	Patients were asked about their average pain levels and current medication usage	1 year	No

External Links

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