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



Status:Terminated
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:5/21/2016
Start Date:January 2008
End Date:June 2010

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Trial Summary
Trial Overview
Inclusion Criteria

Modeling Kappa Opioid Analgesic Mechanisms in Chronic Orofacial Pain Disorders

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.


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
We found this trial at
1
site
University of California at San Francisco
San Francisco, California 94143
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San Francisco, CA
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