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

Not Applicable

Terminated

• Conditions: Temporomandibular Joint Dysfunction Syndrome; Burning Mouth Syndrome
• Interventions: Drug: nalbuphine plus placebo; Drug: nalbuphine plus naloxone

• Registration Number: NCT00716807
• Lead Sponsor: University of California, San Francisco

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-07-14
• Study First Submitted QC: 2008-07-15
• Study First Posted: 2008-07-16
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Results First Submitted: 2013-08-13
• Status Verified: 2013-10
• Results First Submitted QC: 2013-10-17
• Results First Posted: 2013-10-22
• Last Update Submitted: 2016-05-19
• Last Update Posted: 2016-05-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 46

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

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Exclusion Criteria

• No adverse reaction to study drugs
• Not currently using narcotic analgesic drugs

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TMD 2	nalbuphine plus placebo	-
BMS 2	nalbuphine plus placebo	-
BMS 1	nalbuphine plus naloxone	-
TMD 1	nalbuphine plus naloxone	-

Primary Outcome Measures

Name	Time	Method
Pain Intensity as Measured on a Visual Analogue Scale (VAS) Ranging From Zero to 100.	20 minute intervals for three hours.

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States