Opiate-Induced Tolerance & Hyperalgesia in Pain Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

139 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2009-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Sensory Effects of Oral Opioid Treatment in Patients With Chronic Low Back Pain

NCT02824276

Low Back Pain

COMPLETED PHASE1

Human Brain Adaptation to Chronic Pain and Its Effects on Opioid Use

NCT03248765

Pain, Chronic Opioid Use

TERMINATED

Effect of Guanfacine on Opioid-induced Hyperalgesia (OIH) and Tolerance

NCT01681264

Chronic Pain

TERMINATED PHASE4

Stress and Opioid Misuse Risk: The Role of Endogenous Opioid and Endocannabinoid Mechanisms

NCT05142267

Opioid Use Disorder Back Pain Stress

RECRUITING NA

Pain Responses in Patients on Long-Term Opioid Therapy for Chronic Pain

NCT00656942

Chronic Pain

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Low Back Pain Opioid-induced Hyperalgesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1: Placebo Pill

This arm contains placebo medication.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Patients will receive placebo tablets.

2: Morphine

Patients will receive oral morphine therapy.

Group Type ACTIVE_COMPARATOR

Morphine

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Morphine

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

Intervention Type DRUG

Placebo

Patients will receive placebo tablets.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No