Temporomandibular Joint Dysfunction SyndromeNCT00716807
Efficacy of Nalbuphine and Naloxone Administered as Nose Sprays in the Treatment of Orofacial Pain
A study testing nalbuphine plus naloxone in people with Temporomandibular Joint Dysfunction Syndrome and Burning Mouth Syndrome, run by University of California, San Francisco at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Temporomandibular Joint Dysfunction Syndrome, Burning Mouth Syndrome
- What is being tested?
- nalbuphine plus naloxone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Jun 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- No adverse reaction to study drugs
- Not currently using narcotic analgesic drugs
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: 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.
- Being tested
- nalbuphine plus naloxone, nalbuphine plus placebo
- Keywords
- BMS, TMD
- Medical subject headings
- Temporomandibular Joint Dysfunction Syndrome, Burning Mouth Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nalbuphine plus naloxoneDrug
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).
nalbuphine plus placeboDrug
Patient group: temporomandibular disorders. Nalbuphine 5 mg administered by nasal spray (one time only). Placebo (naloxone vehicle) administered by nasal spray (one time only).
nalbuphine plus naloxoneDrug
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).
nalbuphine plus placeboDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| TMD 1 | Experimental | Not described Receives: Drug: nalbuphine plus naloxone |
| TMD 2 | Placebo comparator | Not described Receives: Drug: nalbuphine plus placebo |
| BMS 1 | Experimental | Not described Receives: Drug: nalbuphine plus naloxone |
| BMS 2 | Placebo comparator | Not described Receives: Drug: nalbuphine plus placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity as Measured on a Visual Analogue Scale (VAS) Ranging From Zero to 100.
Measured: 20 minute intervals for three hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2008 (estimated)
- Study startJan 2008
- Primary completionJun 2010
- Study completionJun 2010
Why it stopped: Unable to recruit a sufficient number of subjects.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Temporomandibular Joint Dysfunction SyndromeStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jon D Levine, MD, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00716807
- Sponsor's protocol ID
- NIH/NIDCR R01 DE018526-1
- Other IDs
- 1R01DE018526-01
- Status last verified
- Oct 2013
- First submitted
- 14 Jul 2008
- Last updated
- 20 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modeling Kappa Opioid Analgesic Mechanisms in Chronic Orofacial Pain Disorders
- ClinicalTrials.gov ID
- NCT00716807
- Acronym / sponsor ID
- NIH/NIDCR R01 DE018526-1
- Keywords
- BMS, TMD
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit a sufficient number of subjects.
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 16 Jul 2008 (estimated)
- Results
- Posted 22 Oct 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TMD 1 | Experimental | Drug: nalbuphine plus naloxone |
| TMD 2 | Placebo comparator | Drug: nalbuphine plus placebo |
| BMS 1 | Experimental | Drug: nalbuphine plus naloxone |
| BMS 2 | Placebo comparator | Drug: nalbuphine plus placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- No adverse reaction to study drugs
- Not currently using narcotic analgesic drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nalbuphine plus naloxonePatient group: temporomandibular disorders. Nalbuphine 5 mg administered by nasal spray (one time only). Naloxone 0.4 mg administered by nasal spray (one time only). | Drug | TMD 1 |
| nalbuphine plus placeboPatient group: temporomandibular disorders. Nalbuphine 5 mg administered by nasal spray (one time only). Placebo (naloxone vehicle) administered by nasal spray (one time only). | Drug | TMD 2 |
| nalbuphine plus naloxonePatient 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). | Drug | BMS 1 |
| nalbuphine plus placeboPatient group: Burning mouth syndrome. Nalbuphine 5 mg administered by nasal spray (one time only). Placebo (naloxone vehicle) administered by nasal spray (one time only). | Drug | BMS 2 |
Primary outcome
Pain Intensity as Measured on a Visual Analogue Scale (VAS) Ranging From Zero to 100.
Time frame: 20 minute intervals for three hours.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jon D Levine, MD, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nalbuphine plus naloxone in people with Temporomandibular Joint Dysfunction Syndrome and Burning Mouth Syndrome, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity as Measured on a Visual Analogue Scale (VAS) Ranging From Zero to 100. (time frame: 20 minute intervals for three hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2016.