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

This study has been terminated.
(Unable to recruit a sufficient number of subjects.)
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00716807
First received: July 14, 2008
Last updated: October 17, 2013
Last verified: October 2013
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Modeling Kappa Opioid Analgesic Mechanisms in Chronic Orofacial Pain Disorders

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Pain Intensity as Measured on a Visual Analogue Scale (VAS) Ranging From Zero to 100. [ Time Frame: 20 minute intervals for three hours. ] [ Designated as safety issue: No ]

Enrollment: 46
Study Start Date: January 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
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 Francisco
ClinicalTrials.gov Identifier: NCT00716807     History of Changes
Other Study ID Numbers: NIH/NIDCR R01 DE018526-1, NIH/NIDCR R01 DE018526
Study First Received: July 14, 2008
Results First Received: August 13, 2013
Last Updated: October 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
BMS
TMD

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

ClinicalTrials.gov processed this record on October 23, 2014