Burning Mouth Syndrome, Temporomandibular Joint Dysfunction Syndrome
Conditions
Keywords
BMS, TMD
Brief summary
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.
Interventions
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).
DRUGnalbuphine 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).
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain Intensity as Measured on a Visual Analogue Scale (VAS) Ranging From Zero to 100. | 20 minute intervals for three hours. |
Countries
United States
Participant flow
Recruitment details
Recruitment details unavailable due to death of investigator
Pre-assignment details
pre-assignment details unavailable due to death of investigator
Participants by arm
| Arm | Count |
|---|---|
| BMS Nalbuphine + Naloxone 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). | 8 |
| BMS Nalbuphine + Placebo 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). | 5 |
| TMD Nalbuphine + Naloxone 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). | 18 |
| TMD Nalbuphine + Placebo 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). | 15 |
| Total | 46 |
Baseline characteristics
| Characteristic | BMS Nalbuphine + Naloxone | BMS Nalbuphine + Placebo | TMD Nalbuphine + Naloxone | TMD Nalbuphine + Placebo | Total |
|---|---|---|---|---|---|
| Age, Customized Unknown | 8 Participants | 5 Participants | 18 Participants | 15 Participants | 46 Participants |
| Region of Enrollment United States | 8 participants | 5 participants | 18 participants | 15 participants | 46 participants |
| Sex: Female, Male Female | 5 Participants | 5 Participants | 15 Participants | 13 Participants | 38 Participants |
| Sex: Female, Male Male | 3 Participants | 0 Participants | 3 Participants | 2 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Pain Intensity as Measured on a Visual Analogue Scale (VAS) Ranging From Zero to 100.
Time frame: 20 minute intervals for three hours.
Population: Co-investigators have spent many hours with computer-support personnel trying to locate data on the deceased investigators' computer, but could find nothing other than the gender and treatment assignment for 46 enrolled participants.