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OpenTrials
Completed

NCT Number: NCT00246532

Opiate-Induced Tolerance & Hyperalgesia in Pain Patients

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Stanford University School of Medicine

Stanford, California, 94025, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Morphine

Drug

Patients will be given morphine sulfate oral medication until their back pain is adequately controlled.

Placebo

Drug

Patients will receive placebo tablets.

Primary outcomes

  1. Pain Tolerance

    Time frame: 1 month

  2. Pain Threshold

    Time frame: 1 month

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

National Institute of General Medical Sciences (NIGMS)

Nih

Registry information

Important dates

Study start
2005
Primary completion
2008
Study completion
2009
First posted
Oct 31, 2005
Registry last updated
Apr 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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