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

University of California San Francisco (UCSF)

Status: Terminated

Conditions: Burning Mouth Syndrome; Temporomandibular Joint Dysfunction Syndrome

Treatments: Drug: nalbuphine plus naloxone; Drug: nalbuphine plus placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00716807

NIH/NIDCR R01 DE018526-1

1R01DE018526-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

46 participants in 4 patient groups, including a placebo group

TMD 1

Experimental group

Treatment:

Drug: nalbuphine plus naloxone

Drug: nalbuphine plus naloxone

TMD 2

Placebo Comparator group

Treatment:

Drug: nalbuphine plus placebo

Drug: nalbuphine plus placebo

BMS 1

Experimental group

Treatment:

Drug: nalbuphine plus naloxone

Drug: nalbuphine plus naloxone

BMS 2

Placebo Comparator group

Treatment:

Drug: nalbuphine plus placebo

Drug: nalbuphine plus placebo