Role of the Endogenous Opioid System Underlying Modulation of Experimental Pain

NCT01327326 | Withdrawn

• 1 other identifier: APS2011
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Temporomandibular Disorder; Facial Pain

Keywords

Pain modulation; Experimental pain

Outcome Measures

Primary Outcomes (1)

• 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.

  1 hour after study medication (day 1)

Study Arms (2)

TMD patients

ACTIVE COMPARATOR

Intervention: * Drug: Naltrexone * Drug: placebo

Drug: Naltrexone; Drug: Placebo

Healthy controls

ACTIVE COMPARATOR

Intervention: * Drug: Naltrexone * Drug: placebo

Drug: Naltrexone; Drug: Placebo

Interventions

Naltrexone DRUG

Oral, 50 mg, 1 Time Dose

Also known as: Revia

Healthy controls; TMD patients

Placebo DRUG

Oral, 1 Time Dose

Also known as: Placebo/sugar pill

Healthy controls; TMD patients

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Florida: lead
• American Pain Society: collaborator

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Facial Pain

Interventions

Naltrexone; Sugars

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Naloxone; 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; Carbohydrates

Study Officials

• Christopher D King, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2011
• First Posted: April 1, 2011
• Study Start: December 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: July 13, 2012

Record last verified: 2012-07