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

NCT00716807 | Terminated Results DMC

• 2 other identifiers: NIH/NIDCR R01 DE018526-11R01DE018526-01
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Temporomandibular Joint Dysfunction Syndrome; Burning Mouth Syndrome

Keywords

BMS; TMD

Outcome Measures

Primary Outcomes (1)

• Pain Intensity as Measured on a Visual Analogue Scale (VAS) Ranging From Zero to 100.

  20 minute intervals for three hours.

Study Arms (4)

TMD 1

EXPERIMENTAL

Drug: nalbuphine plus naloxone

TMD 2

PLACEBO COMPARATOR

Drug: nalbuphine plus placebo

BMS 1

EXPERIMENTAL

Drug: nalbuphine plus naloxone

BMS 2

PLACEBO COMPARATOR

Drug: nalbuphine plus placebo

Interventions

nalbuphine plus naloxone 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 1

nalbuphine plus placebo 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).

TMD 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Temporomandibular Joint Dysfunction Syndrome; Burning Mouth Syndrome

Interventions

Nalbuphine; Naloxone

Condition Hierarchy (Ancestors)

Temporomandibular Joint Disorders; Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Myofascial Pain Syndromes; Stomatognathic Diseases; Mouth Diseases

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Limitations and Caveats

Dr. Robert Gear led this study and maintained data on his computer. Co-investigators have spent many hours trying to locate data on the deceased investigators' computer, but could find nothing other than the minimal results data entered here.

Results Point of Contact

• Title: Jon Levine MD, PhD
• Organization: UCSF

jon.levine@ucsf.edu

415-476-5108

Study Officials

• Jon D Levine, MD, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2008
• First Posted: July 16, 2008
• Study Start: January 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: May 20, 2016
• Results First Posted: October 22, 2013

Record last verified: 2013-10

Locations

US (1)