Back to resultsEfficacy of Nalbuphine and Naloxone Administered as Nose Sprays in the Treatment of Orofacial Pain
Primary Purpose
Temporomandibular Joint Dysfunction Syndrome, Burning Mouth Syndrome
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
nalbuphine plus naloxone
nalbuphine plus placebo
nalbuphine plus naloxone
nalbuphine plus placebo
Sponsored by
About this trial
This is an interventional basic science trial for Temporomandibular Joint Dysfunction Syndrome focused on measuring BMS, TMD
Eligibility Criteria
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
Sites / Locations
- University of California, San Francisco
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
TMD 1
TMD 2
BMS 1
BMS 2
Arm Description
Outcomes
Primary Outcome Measures
Pain Intensity as Measured on a Visual Analogue Scale (VAS) Ranging From Zero to 100.
Secondary Outcome Measures
Full Information
NCT ID
NCT00716807
First Posted
July 14, 2008
Last Updated
May 19, 2016
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT00716807
Brief Title
Efficacy of Nalbuphine and Naloxone Administered as Nose Sprays in the Treatment of Orofacial Pain
Official Title
Modeling Kappa Opioid Analgesic Mechanisms in Chronic Orofacial Pain Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Terminated
Why Stopped
Unable to recruit a sufficient number of subjects.
Study Start Date
January 2008 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Joint Dysfunction Syndrome, Burning Mouth Syndrome
Keywords
BMS, TMD
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TMD 1
Arm Type
Experimental
Arm Title
TMD 2
Arm Type
Placebo Comparator
Arm Title
BMS 1
Arm Type
Experimental
Arm Title
BMS 2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
nalbuphine plus naloxone
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
nalbuphine plus placebo
Intervention Description
Patient group: temporomandibular disorders. Nalbuphine 5 mg administered by nasal spray (one time only). Placebo (naloxone vehicle) administered by nasal spray (one time only).
Intervention Type
Drug
Intervention Name(s)
nalbuphine plus naloxone
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
nalbuphine plus placebo
Intervention Description
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).
Primary Outcome Measure Information:
Title
Pain Intensity as Measured on a Visual Analogue Scale (VAS) Ranging From Zero to 100.
Time Frame
20 minute intervals for three hours.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon D Levine, MD, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Nalbuphine and Naloxone Administered as Nose Sprays in the Treatment of Orofacial Pain
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