- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01327326
Role of the Endogenous Opioid System Underlying Modulation of Experimental Pain
Opioid Modulation of Two Models of Pain Inhibition in Healthy Controls and Patients With Temporomandibular Disorder (TMD)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Dysfunction in endogenous pain inhibitory systems has been proposed as a factor in the development and maintenance clinical pain disorders particularly in Temporomandibular Disorder (TMD). Dysfunction has been observed with a model known as diffuse noxious inhibitory controls (DNIC), but other models that engage inhibitory systems (offset analgesia) have not been fully evaluated in chronic pain patients.
DNIC evaluates an individual's capacity to engage endogenous pain inhibition. The paradigm is a spatial inhibition model based on the principle that "pain-inhibits-pain" in which pain in a local area is inhibited by a second pain that can be anywhere else in the body. DNIC is traditionally studied by observing a reduction of pain produced by a focal pain stimulus (contact heat) as a result of a second painful stimulus. Research from our lab and others suggests that pain inhibition is reduced in a number of chronic pain conditions. The investigators preliminary data suggests that pain inhibition during DNIC is modulated in part by endogenous opioids; however, results from other DNIC studies have been mixed. In addition, it is possible that reductions in the ability to engage endogenous inhibitory systems in chronic pain patients are due to a weakening of the endogenous opioid system. While pharmacological studies have been conducted with healthy cohorts, only one study has examined the opioid involvement in chronic pain patients.
Offset analgesia is thought to reflect a form of temporal pain inhibition which is usually defined by three stimulus temperature phases: a baseline phase followed by a manipulation phase in which the temperature is briefly increased and returns to the baseline temperature during an "offset" phase. A reduction in pain ratings is observed approximately 15s after the temperature drop (third phase), which is ~50% lower than ratings at the same time point for "constant" trials that continued 48°C for 40s. No studies have examined offset analgesia in a chronic pain cohort or its sensitivity of opioid blockade.
Study Type
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- ages 18-50 years old
- Controls: pain-free based on Research Diagnostic Criteria (RDC) exam
- TMD: chronic musculoskeletal pain (face) based on Research Diagnostic Criteria (RDC) exam
Exclusion Criteria:
- Inability to adequately communicate and understand informed consent form;
- Inability to reliably rate pain intensity;
- Uncontrolled hypertension (or receiving treatment for hypertension with BP of greater than 140/95);
- Serious systemic (e.g. Diabetes, thyroid problems, etc.);
- Serious cardiovascular/pulmonary disease;
- Neurological problems with significant changes in somatosensory and pain perception at the intended stimulation sites (hand, foot);
- Serious psychiatric problems requiring treatment (schizophrenia, bipolar disorder);
- Other chronic pain conditions (e.g., low back pain, fibromyalgia);
- Any other ongoing acute pain problem (arthritis, injury-related pain); or,
- Irregular menstrual cycles (>40 days) or menstrual cycle disorders (e.g. PMS, dysmenorrhea).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: TMD patients
Intervention:
|
Oral, 50 mg, 1 Time Dose
Other Names:
Oral, 1 Time Dose
Other Names:
|
Active Comparator: Healthy controls
Intervention:
|
Oral, 50 mg, 1 Time Dose
Other Names:
Oral, 1 Time Dose
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-drug efficacy of pain inhibition
Time Frame: 1 hour after study medication (day 1)
|
A change in the ability to reduce experimental pain sensitivity during two models of pain inhibition will be evaluated before and after medication.
|
1 hour after study medication (day 1)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Christopher D King, PhD, University of Florida
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Joint Diseases
- Musculoskeletal Diseases
- Muscular Diseases
- Stomatognathic Diseases
- Jaw Diseases
- Craniomandibular Disorders
- Mandibular Diseases
- Myofascial Pain Syndromes
- Temporomandibular Joint Disorders
- Temporomandibular Joint Dysfunction Syndrome
- Facial Pain
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Sensory System Agents
- Narcotic Antagonists
- Alcohol Deterrents
- Naltrexone
Other Study ID Numbers
- APS2011
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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