Opiate-Induced Tolerance & Hyperalgesia in Pain Patients

April 26, 2012 updated by: Dr. Lawrence Chu, National Institute of General Medical Sciences (NIGMS)
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

139

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94025
        • Stanford University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1: Placebo Pill
This arm contains placebo medication.
Drug: Placebo
Patients will receive placebo tablets.
Active Comparator: 2: Morphine
Patients will receive oral morphine therapy.
Drug: Morphine
Patients will be given morphine sulfate oral medication until their back pain is adequately controlled.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain Tolerance
Time Frame: 1 month
1 month
Pain Threshold
Time Frame: 1 month
1 month

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of General Medical Sciences (NIGMS)

Investigators

  • Principal Investigator: Lawrence F Chu, MD, MS, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

October 26, 2005

First Submitted That Met QC Criteria

October 27, 2005

First Posted (Estimate)

October 30, 2005

Study Record Updates

Last Update Posted (Estimate)

April 30, 2012

Last Update Submitted That Met QC Criteria

April 26, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5K23GM071400-02 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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