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
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;
Show all 16Show fewer
- 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.
- 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