Opiate-Induced Tolerance & Hyperalgesia in Pain Patients

NCT00246532 | Completed Phase 4 DMC

• 1 other identifier: 5K23GM071400-02
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low Back Pain; Opioid-induced Hyperalgesia

Outcome Measures

Primary Outcomes (2)

• Pain Tolerance

  1 month

• Pain Threshold

  1 month

Secondary Outcomes (5)

• Opioid Titration

  1 month

• Pain Intensity

  1 month

• Roland-Morris Disability Index

  1 month

• Beck Depression Inventory

  1 month

• Follow-Up Survey

  1 year

Study Arms (2)

1: Placebo Pill

PLACEBO COMPARATOR

This arm contains placebo medication.

Drug: Placebo

2: Morphine

ACTIVE COMPARATOR

Patients will receive oral morphine therapy.

Drug: Morphine

Interventions

Morphine DRUG

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

2: Morphine

Placebo DRUG

Patients will receive placebo tablets.

1: Placebo Pill

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of General Medical Sciences (NIGMS): lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94025, United States

Location

MeSH Terms

Interventions

Morphine

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Lawrence F Chu, MD, MS

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: National Institute of General Medical Sciences

Study Record Dates

• First Submitted: October 26, 2005
• First Posted: October 31, 2005
• Study Start: October 1, 2005
• Primary Completion: December 1, 2008
• Study Completion: August 1, 2009
• Last Updated: April 30, 2012

Record last verified: 2012-04

Locations

US (1)