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

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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
United States, California | |
University of California, San Francisco | |
San Francisco, California, United States, 94143 |
Principal Investigator: | Jon D Levine, MD, PhD | University of California, San Francisco |
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 |
BMS TMD |
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 |