Opiate-Induced Tolerance & Hyperalgesia in Pain Patients

Phase 4

Completed

• Conditions: Chronic Low Back Pain; Opioid-induced Hyperalgesia
• Interventions: Drug: Placebo; Drug: Morphine

• Registration Number: NCT00246532
• Lead Sponsor: National Institute of General Medical Sciences (NIGMS)

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2005-10-26
• Study First Submitted QC: 2005-10-27
• Study First Posted: 2005-10-30
• Primary Completion: 2008-12
• Study Completion: 2009-08
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-26
• Last Update Posted: 2012-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 139

Inclusion Criteria

• opioid naïve (or less than 4 vicodin equiv/day)
• 18-70 years old
• candidate for opioid therapy for nonmalignant pain.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1: Placebo Pill	Placebo	This arm contains placebo medication.
2: Morphine	Morphine	Patients will receive oral morphine therapy.

Primary Outcome Measures

Name	Time	Method
Pain Tolerance	1 month
Pain Threshold	1 month

Secondary Outcome Measures

Name	Time	Method
Opioid Titration	1 month
Pain Intensity	1 month
Roland-Morris Disability Index	1 month
Beck Depression Inventory	1 month
Follow-Up Survey	1 year	Patients were asked about their average pain levels and current medication usage

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States