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

Stopped early · Not applicable · Has a placebo group

Conditions studied: Temporomandibular Joint Dysfunction Syndrome, Burning Mouth Syndrome

In brief

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.

Key facts

Study ID

NCT00716807

Run by

University of California, San Francisco

People needed

46

Starts

2008-01-01

Expected to finish

2010-06-01

Last updated by the study team

2016-05-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• No adverse reaction to study drugs
• Not currently using narcotic analgesic drugs

Where it is running

• University of California, San Francisco — San Francisco, California, United States

Full record on ClinicalTrials.gov

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