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

Burning Mouth Syndrome Clinical Trial

Official title:

Modeling Kappa Opioid Analgesic Mechanisms in Chronic Orofacial Pain Disorders

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00716807
• Other study ID #: NIH/NIDCR R01 DE018526-1
• Secondary ID: 1R01DE018526-01
• Status: Terminated
• Phase: N/A
• First received: July 14, 2008
• Last updated: May 19, 2016
• Start date: January 2008
• Est. completion date: June 2010

Study information

• Verified date: October 2013
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 46
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Burning Mouth Syndrome
• Joint Diseases
• Syndrome
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

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).
• 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).
• 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).
• 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).

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Intensity as Measured on a Visual Analogue Scale (VAS) Ranging From Zero to 100.		20 minute intervals for three hours.	No