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

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

This study is currently recruiting participants.
Verified by University of California, San Francisco, December 2008
First Received: July 14, 2008 Last Updated: December 16, 2008 History of Changes
Sponsored by: University of California, San Francisco
Information provided by: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00716807
Purpose

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.

Condition Intervention
Temporomandibular Joint Dysfunction Syndrome
Burning Mouth Syndrome
Drug: nalbuphine plus naloxone
Drug: nalbuphine plus placebo

MedlinePlus related topics: Joint Disorders Temporomandibular Joint Dysfunction
Drug Information available for: Nalbuphine Nalbuphine hydrochloride Naloxone hydrochloride Naloxone
U.S. FDA Resources
Study Type: Interventional
Study Design: Basic Science, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title: Modeling Kappa Opioid Analgesic Mechanisms in Chronic Orofacial Pain Disorders

Further study details as provided by University of California, San Francisco:

Estimated Enrollment: 80
Study Start Date: January 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
TMD 1: Experimental 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).
TMD 2: Placebo Comparator 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).
BMS 1: Experimental 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).
BMS 2: Placebo Comparator 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).

Eligibility

Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria

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

Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00716807

Contacts
Contact: Robert W Gear, DDS, PhD 415-476-0604 robert.gear@ucsf.edu

Locations
United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Robert Gear, DDS, PhD robert.gear@ucsf.edu
Contact: Chaitra K Bhat, DDS 415-476-0604 chaitra.bhat@ucsf.edu
Principal Investigator: Jon D Levine, MD, PhD
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Jon D Levine, MD, PhD University of California, San Francisco
More Information

No publications provided

Responsible Party: University of California, San Fancisco ( Jon D. Levine, MD, PhD, Professor )
Study ID Numbers: NIH/NIDCR R01 DE018526-1, NIH/NIDCR R01 DE018526
Study First Received: July 14, 2008
Last Updated: December 16, 2008
ClinicalTrials.gov Identifier: NCT00716807 History of Changes
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Mouth Diseases
Nalbuphine
Facial Pain
Facies
Myofascial Pain Syndromes
Fibromyalgia
Joint Diseases
Narcotic Antagonists
Central Nervous System Depressants
Narcotics
Pain
Naloxone
Signs and Symptoms
Temporomandibular Joint Disorders
Muscular Diseases
Temporomandibular Joint Dysfunction Syndrome
Musculoskeletal Diseases
Craniomandibular Disorders
Neurologic Manifestations
Peripheral Nervous System Agents
Analgesics
Stomatognathic Diseases
Analgesics, Opioid
Burning Mouth Syndrome

Additional relevant MeSH terms:
Myofascial Pain Syndromes
Mouth Diseases
Mandibular Diseases
Narcotic Antagonists
Physiological Effects of Drugs
Jaw Diseases
Pain
Naloxone
Signs and Symptoms
Temporomandibular Joint Disorders
Pathologic Processes
Musculoskeletal Diseases
Sensory System Agents
Therapeutic Uses
Craniomandibular Disorders
Syndrome
Analgesics
Analgesics, Opioid
Burning Mouth Syndrome
Nalbuphine
Disease
Facial Pain
Joint Diseases
Nervous System Diseases
Central Nervous System Depressants
Narcotics
Pharmacologic Actions
Muscular Diseases
Temporomandibular Joint Dysfunction Syndrome
Neurologic Manifestations

ClinicalTrials.gov processed this record on April 17, 2009