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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-06-30

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.

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Detailed Description

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Conditions

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Temporomandibular Joint Dysfunction Syndrome Burning Mouth Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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TMD 1

Group Type EXPERIMENTAL

nalbuphine plus naloxone

Intervention Type DRUG

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).

TMD 2

Group Type PLACEBO_COMPARATOR

nalbuphine plus placebo

Intervention Type DRUG

Patient group: temporomandibular disorders. Nalbuphine 5 mg administered by nasal spray (one time only). Placebo (naloxone vehicle) administered by nasal spray (one time only).

BMS 1

Group Type EXPERIMENTAL

nalbuphine plus naloxone

Intervention Type DRUG

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).

BMS 2

Group Type PLACEBO_COMPARATOR

nalbuphine plus placebo

Intervention Type DRUG

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).

Interventions

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nalbuphine plus naloxone

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).

Intervention Type DRUG

nalbuphine plus placebo

Patient group: temporomandibular disorders. Nalbuphine 5 mg administered by nasal spray (one time only). Placebo (naloxone vehicle) administered by nasal spray (one time only).

Intervention Type DRUG

nalbuphine plus naloxone

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).

Intervention Type DRUG

nalbuphine plus placebo

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).

Intervention Type DRUG

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