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Opiate-Induced Tolerance & Hyperalgesia in Pain Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00246532
Recruitment Status : Completed
First Posted : October 30, 2005
Last Update Posted : April 30, 2012
Sponsor:
Information provided by (Responsible Party):
Dr. Lawrence Chu, Stanford University

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.

Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Opioid-induced Hyperalgesia Drug: Morphine Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 139 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Official Title: Opiate-Induced Tolerance & Hyperalgesia in Pain Patients
Study Start Date : October 2005
Actual Primary Completion Date : December 2008
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Pain Tolerance [ Time Frame: 1 month ]
  2. Pain Threshold [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. Opioid Titration [ Time Frame: 1 month ]
  2. Pain Intensity [ Time Frame: 1 month ]
  3. Roland-Morris Disability Index [ Time Frame: 1 month ]
  4. Beck Depression Inventory [ Time Frame: 1 month ]
  5. Follow-Up Survey [ Time Frame: 1 year ]
    Patients were asked about their average pain levels and current medication usage



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00246532


Locations
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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94025
Sponsors and Collaborators
National Institute of General Medical Sciences (NIGMS)
Investigators
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Principal Investigator: Lawrence F Chu, MD, MS Stanford University

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Responsible Party: Dr. Lawrence Chu, National Institute of General Medical Sciences, Stanford University
ClinicalTrials.gov Identifier: NCT00246532    
Other Study ID Numbers: 5K23GM071400-02 ( U.S. NIH Grant/Contract )
5K23GM071400-02 ( U.S. NIH Grant/Contract )
First Posted: October 30, 2005    Key Record Dates
Last Update Posted: April 30, 2012
Last Verified: April 2012
Additional relevant MeSH terms:
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Hyperalgesia
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Somatosensory Disorders
Sensation Disorders
Nervous System Diseases
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents