Role of the Endogenous Opioid System Underlying Modulation of Experimental Pain
Primary Purpose
Temporomandibular Disorder, Facial Pain
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Naltrexone
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Temporomandibular Disorder focused on measuring Pain modulation, Experimental pain
Eligibility Criteria
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).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
TMD patients
Healthy controls
Arm Description
Intervention: Drug: Naltrexone Drug: placebo
Intervention: Drug: Naltrexone Drug: placebo
Outcomes
Primary Outcome Measures
Post-drug efficacy of pain inhibition
A change in the ability to reduce experimental pain sensitivity during two models of pain inhibition will be evaluated before and after medication.
Secondary Outcome Measures
Full Information
NCT ID
NCT01327326
First Posted
March 24, 2011
Last Updated
July 11, 2012
Sponsor
University of Florida
Collaborators
American Pain Society
1. Study Identification
Unique Protocol Identification Number
NCT01327326
Brief Title
Role of the Endogenous Opioid System Underlying Modulation of Experimental Pain
Official Title
Opioid Modulation of Two Models of Pain Inhibition in Healthy Controls and Patients With Temporomandibular Disorder (TMD)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Withdrawn
Study Start Date
December 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
American Pain Society
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this proposal is to characterize pain inhibition in healthy controls and Temporomandibular Disorder (TMD) patients with two models of endogenous pain modulation (off-set analgesia; conditioned pain modulation), and to investigate the function of the endogenous opioid system in these responses by using pharmacological blockade of the opioid receptor.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Disorder, Facial Pain
Keywords
Pain modulation, Experimental pain
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TMD patients
Arm Type
Active Comparator
Arm Description
Intervention:
Drug: Naltrexone
Drug: placebo
Arm Title
Healthy controls
Arm Type
Active Comparator
Arm Description
Intervention:
Drug: Naltrexone
Drug: placebo
Intervention Type
Drug
Intervention Name(s)
Naltrexone
Other Intervention Name(s)
Revia
Intervention Description
Oral, 50 mg, 1 Time Dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo/sugar pill
Intervention Description
Oral, 1 Time Dose
Primary Outcome Measure Information:
Title
Post-drug efficacy of pain inhibition
Description
A change in the ability to reduce experimental pain sensitivity during two models of pain inhibition will be evaluated before and after medication.
Time Frame
1 hour after study medication (day 1)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher D King, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Role of the Endogenous Opioid System Underlying Modulation of Experimental Pain
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