NCT00716807

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

Modeling Kappa Opioid Analgesic Mechanisms in Chronic Orofacial Pain Disorders

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Temporomandibular Joint Dysfunction Syndrome
• Burning Mouth Syndrome

Interventions

Type	Name	Description
DRUG	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).
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).
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).
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).

Timeline

• Start date: 2008-01-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2008-07-16
• Last updated: 2016-05-20
• Results posted: 2013-10-22

Locations

1 site across 1 country: United States