Temporomandibular Disorder (TMD)Early Phase 1TMDNCT06659991
JIT: Effect of Pain on DT in TMD
A Early Phase 1 study testing alcohol condition in people with Temporomandibular Disorder (TMD), run by University of Minnesota at 1 site in United States.
Trial summary
Individuals with chronic temporomandibular disorder (TMD) pain are at increased risk for alcohol-related consequences compared to those without pain, and growing evidence suggests pain is a potent motivator for alcohol use in many individuals. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Disorder (TMD)
- What is being tested?
- alcohol condition
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2025to 7 Sep 2029
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants in this study must be 21 years to 65 years of age and provide a driver's license or other state-issued ID.
- Participants must also be sufficiently fluent in English to provide informed consent and understand questionnaires and instructions for laboratory procedures.
- Participants must report drinking of, on average, at least 1 drink 3 days/week over the past 6 months.
- Meet Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for myalgia (masticatory muscle pain), arthralgia (TMJ pain), or a combination (Schiffman et al., 2014) (TMD group only).
- Own a smartphone with internet access.
- Use of prescription medications will be allowed, provided they do not contraindicate alcohol use.
Who cannot join
- Use of opioid analgesics within the past month;
- Current major depression;
- History of any psychotic disorder;
- Under-controlled hypertension or diabetes (as reflected by self-report); neurological disease (e.g., multiple sclerosis, epilepsy, amyotrophic lateral sclerosis, Parkinson's disease);
- Serious medical illness (e.g., hepatitis, HIV/AIDS);
- Impaired cognitive function;
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- History of substance use disorder (including nicotine/tobacco);
- Alcohol naïve
- Alcohol use disorder, or currently attempting to quit or cut down on using alcohol
- Positive pregnancy test
- Breastfeeding or intending to become pregnant
- Loss of sensation in the lower leg
- Inability to complete study tasks due to weakness, immobilization, or loss of limbs
- Chronic pain (Control group only)
- A urine-based drug screen for tetrahydrocannabinol, cocaine, benzodiazepines, morphine, and methamphetamine (Innovacon, Inc., San Diego, CA) will be performed. Participants testing positive for any substance will be discontinued.
- Medications that contraindicate alcohol use
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55414
Jeff Boissoneault
About this study
Official title: JIT: Effects of Pain on Laboratory Drinking Topography and Daily Drinking in People With Chronic Temporomandibular Disorder (TMD) Pain
Individuals with chronic temporomandibular disorder (TMD) pain are at increased risk for alcohol-related consequences compared to those without pain, and growing evidence suggests pain is a potent motivator for alcohol use in many individuals. However, few systematic examinations of modifiable and non-modifiable risk factors, including orofacial pain status, have been conducted. This project addresses this gap in knowledge by determining the effect of pain on drinking topography in heavy drinkers with and without chronic TMD pain in both the laboratory and daily life.
- Conditions
- Temporomandibular Disorder (TMD)
- Being tested
- alcohol condition, control condition
- Keywords
- alcohol, temporomandibular disorder (TMD), chronic pain
- Medical subject headings
- Temporomandibular Joint Disorders, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alcohol conditionDrug
Ethanol
control conditionOther
sparkling water
| Study group | Role | What they receive |
|---|---|---|
| TMD Group 1 | Experimental | People with an established diagnosis of temporomandibular disorder (TMD) assigned to Ethanol intervention Receives: Drug: alcohol condition |
| TMD Group 2 | Sham comparator | People with an established diagnosis of temporomandibular disorder (TMD) assigned to sparkling water (control) Receives: Other: control condition |
| Pain-free Control Group 1 | Experimental | People without an established diagnosis of temporomandibular disorder (TMD) or other chronic pain condition assigned to Ethanol intervention Receives: Drug: alcohol condition |
| Pain-free Control Group 2 | Sham comparator | People without an established diagnosis of temporomandibular disorder (TMD) or other chronic pain condition assigned to sparkling water (control) Receives: Other: control condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol Use Topography
Variables reflecting microstructure of alcohol use during self-administration, including sip interval and sip volume.
Measured: 30 minutes
Heat Pain Intensity
Pain intensity of heat stimuli applied during self- administration sessions.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start14 May 2025
- Primary completion7 Sep 2029 (estimated)
- Study completion7 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Disorder (TMD)Studies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a crossover design wherein participants consume either alcohol-containing beverages (beer or cider) or sparkling water over two laboratory sessions.
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeff Boissoneault, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06659991
- Sponsor's protocol ID
- ANES-2024-33184
- Acronym
- TMD
- Status last verified
- Jul 2026
- First submitted
- 24 Oct 2024
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- JIT: Effects of Pain on Laboratory Drinking Topography and Daily Drinking in People With Chronic Temporomandibular Disorder (TMD) Pain
- ClinicalTrials.gov ID
- NCT06659991
- Acronym / sponsor ID
- TMD / ANES-2024-33184
- Conditions
- Temporomandibular Disorder (TMD)
- Keywords
- alcohol, temporomandibular disorder (TMD), chronic pain
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 14 May 2025 (actual)
- Primary completion
- 7 Sep 2029 (estimated)
- Study completion
- 7 Sep 2029 (estimated)
- First posted
- 26 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Individuals with chronic temporomandibular disorder (TMD) pain are at increased risk for alcohol-related consequences compared to those without pain, and growing evidence suggests pain is a potent motivator for alcohol use in many individuals. However, few systematic examinations of modifiable and non-modifiable risk factors, including orofacial pain status, have been conducted. This project addresses this gap in knowledge by determining the effect of pain on drinking topography in heavy drinkers with and without chronic TMD pain in both the laboratory and daily life.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This is a crossover design wherein participants consume either alcohol-containing beverages (beer or cider) or sparkling water over two laboratory sessions.
| Arm | Type | Receives |
|---|---|---|
| TMD Group 1 | Experimental | Drug: alcohol conditionPeople with an established diagnosis of temporomandibular disorder (TMD) assigned to Ethanol intervention |
| TMD Group 2 | Sham comparator | Other: control conditionPeople with an established diagnosis of temporomandibular disorder (TMD) assigned to sparkling water (control) |
| Pain-free Control Group 1 | Experimental | Drug: alcohol conditionPeople without an established diagnosis of temporomandibular disorder (TMD) or other chronic pain condition assigned to Ethanol intervention |
| Pain-free Control Group 2 | Sham comparator | Other: control conditionPeople without an established diagnosis of temporomandibular disorder (TMD) or other chronic pain condition assigned to sparkling water (control) |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants in this study must be 21 years to 65 years of age and provide a driver's license or other state-issued ID.
- Participants must also be sufficiently fluent in English to provide informed consent and understand questionnaires and instructions for laboratory procedures.
- Participants must report drinking of, on average, at least 1 drink 3 days/week over the past 6 months.
- Meet Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for myalgia (masticatory muscle pain), arthralgia (TMJ pain), or a combination (Schiffman et al., 2014) (TMD group only).
- Own a smartphone with internet access.
Key exclusion criteria (16 listed)
- Use of opioid analgesics within the past month;
- Current major depression;
- History of any psychotic disorder;
- Under-controlled hypertension or diabetes (as reflected by self-report); neurological disease (e.g., multiple sclerosis, epilepsy, amyotrophic lateral sclerosis, Parkinson's disease);
- Serious medical illness (e.g., hepatitis, HIV/AIDS);
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 |
|---|---|---|
| alcohol conditionEthanol | Drug | Pain-free Control Group 1, TMD Group 1 |
| control conditionsparkling water | Other | Pain-free Control Group 2, TMD Group 2 |
Primary outcome
Alcohol Use Topography
Time frame: 30 minutes
Variables reflecting microstructure of alcohol use during self-administration, including sip interval and sip volume.
Heat Pain Intensity
Time frame: 30 minutes
Pain intensity of heat stimuli applied during self- administration sessions.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
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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.
Jeff Boissoneault principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing alcohol condition in people with Temporomandibular Disorder (TMD), run by University of Minnesota 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 6 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 9 Jul 2026. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeff Boissoneault (612-624-6357, jboisson@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol Use Topography (time frame: 30 minutes). The study lists 2 primary outcomes in all. 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 9 Jul 2026.