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

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ClinicalTrials.gov Identifier: NCT00716807
Recruitment Status : Terminated (Unable to recruit a sufficient number of subjects.)
First Posted : July 16, 2008
Results First Posted : October 22, 2013
Last Update Posted : May 20, 2016
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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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.

Condition or disease Intervention/treatment Phase
Temporomandibular Joint Dysfunction Syndrome Burning Mouth Syndrome Drug: nalbuphine plus naloxone Drug: nalbuphine plus placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Modeling Kappa Opioid Analgesic Mechanisms in Chronic Orofacial Pain Disorders
Study Start Date : January 2008
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

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Arms and Interventions
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Arm Intervention/treatment
Experimental: TMD 1 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).
Placebo Comparator: TMD 2 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).
Experimental: BMS 1 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).
Placebo Comparator: BMS 2 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).


Outcome Measures
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Primary Outcome Measures :
  1. Pain Intensity as Measured on a Visual Analogue Scale (VAS) Ranging From Zero to 100. [ Time Frame: 20 minute intervals for three hours. ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00716807


Locations
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Jon D Levine, MD, PhD University of California, San Francisco
More Information
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00716807    
Other Study ID Numbers: NIH/NIDCR R01 DE018526-1
1R01DE018526-01 ( U.S. NIH Grant/Contract )
First Posted: July 16, 2008    Key Record Dates
Results First Posted: October 22, 2013
Last Update Posted: May 20, 2016
Last Verified: October 2013
Keywords provided by University of California, San Francisco:
BMS
TMD
Additional relevant MeSH terms:
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Joint Diseases
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Burning Mouth Syndrome
Syndrome
Facial Pain
Disease
Pathologic Processes
Musculoskeletal Diseases
Mouth Diseases
Stomatognathic Diseases
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
 Muscular Diseases
Myofascial Pain Syndromes
Pain
Neurologic Manifestations
Nalbuphine
Naloxone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Analgesics