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Sponsored by: |
University of California, San Francisco |
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Information provided by: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT00716807 |
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 |
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Temporomandibular Joint Dysfunction Syndrome Burning Mouth Syndrome |
Drug: nalbuphine plus naloxone Drug: nalbuphine plus placebo |
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 |
Estimated Enrollment: | 80 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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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).
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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).
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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).
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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).
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Robert W Gear, DDS, PhD | 415-476-0604 | robert.gear@ucsf.edu |
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 |
Principal Investigator: | Jon D Levine, MD, PhD | University of California, San Francisco |
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: | June 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00716807 History of Changes |
Health Authority: | United States: Institutional Review Board |
BMS TMD |
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 |
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 Myofascial Pain Syndromes Joint Diseases Nervous System Diseases Central Nervous System Depressants Narcotics Pharmacologic Actions Muscular Diseases Temporomandibular Joint Dysfunction Syndrome Neurologic Manifestations |