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:
University of California, San Francisco
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00716807
First received: July 14, 2008
Last updated: May 19, 2016
Last verified: October 2013
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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 (Adult, Senior) |
| 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
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
| Responsible Party: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT00716807 History of Changes |
| Other Study ID Numbers: | NIH/NIDCR R01 DE018526-1 1R01DE018526-01 |
| Study First Received: | July 14, 2008 |
| Results First Received: | August 13, 2013 |
| Last Updated: | May 19, 2016 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, San Francisco:
|
BMS TMD |
Additional relevant MeSH terms:
|
Syndrome Joint Diseases Burning Mouth Syndrome Facial Pain Temporomandibular Joint Disorders Temporomandibular Joint Dysfunction Syndrome Disease Pathologic Processes Musculoskeletal Diseases Mouth Diseases Stomatognathic Diseases Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
Craniomandibular Disorders Mandibular Diseases Jaw Diseases Muscular Diseases Myofascial Pain Syndromes Naloxone Nalbuphine Narcotic Antagonists Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents Analgesics, Opioid Narcotics Central Nervous System Depressants Analgesics |
ClinicalTrials.gov processed this record on September 26, 2016