Efficacy of Nalbuphine and Naloxone Administered as Nose Sprays in the Treatment of Orofacial Pain

Study Overview
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Brief Summary
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Patients with chronic masticatory muscle pain (i.e., pain greater than three months) or patients with burning mouth syndrome participate in this study. The aim of the study is to compare the pain killing effectiveness of nalbuphine, a narcotic pain killer, administered with either placebo or naloxone, a drug used to treat opiate overdose. A second goal is to determine if there are sex differences in these two drug regimens. Drugs will be administered with single-use intranasal spray devices. All participants will receive two sprays (one spray per nostril). One of the two sprays will be nalbuphine (5 mg). The other spray will be naloxone in half the participants and placebo in the other half.

Official Title
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Modeling Kappa Opioid Analgesic Mechanisms in Chronic Orofacial Pain Disorders

Conditions
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Temporomandibular Joint Dysfunction Syndrome, Burning Mouth Syndrome

Intervention / Treatment
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* Drug: nalbuphine plus naloxone
* Drug: nalbuphine plus placebo
* Drug: nalbuphine plus naloxone
* Drug: nalbuphine plus placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of temporomandibular muscle pain OR Clinical diagnosis of burning mouth syndrome Pain duration: at least 3 months Pain severity: 2 or greater on a 0 - 10 scale Exclusion Criteria: No adverse reaction to study drugs Not currently using narcotic analgesic drugs

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TMD 1<br> | Drug: nalbuphine plus naloxone<br>* Patient group: temporomandibular disorders. Nalbuphine 5 mg administered by nasal spray (one time only). Naloxone 0.4 mg administered by nasal spray (one time only).<br>|
| Placebo Comparator: TMD 2<br> | Drug: nalbuphine plus placebo<br>* Patient group: temporomandibular disorders. Nalbuphine 5 mg administered by nasal spray (one time only). Placebo (naloxone vehicle) administered by nasal spray (one time only).<br>|
| Experimental: BMS 1<br> | Drug: nalbuphine plus naloxone<br>* Patient group: burning mouth syndrome. Nalbuphine 5 mg administered by nasal spray (one time only). Naloxone 0.4 mg administered by nasal spray (one time only).<br>|
| Placebo Comparator: BMS 2<br> | Drug: nalbuphine plus placebo<br>* Patient group: Burning mouth syndrome. Nalbuphine 5 mg administered by nasal spray (one time only). Placebo (naloxone vehicle) administered by nasal spray (one time only).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity as Measured on a Visual Analogue Scale (VAS) Ranging From Zero to 100. |  | 20 minute intervals for three hours. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BMS, TMD