RecruitingEarly Phase 1

JIT: Effect of Pain on DT in TMD

United States160 participantsStarted 2025-05-14

Plain-language 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. 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.

Who can participate

Age range

21 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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; * 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 l…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Alcohol Use Topography

Timeframe: 30 minutes

Heat Pain Intensity

Timeframe: 30 minutes

Trial details

NCT IDNCT06659991

SponsorUniversity of Minnesota

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-09-07

Contact for this trial

Jeff Boissoneault

612-624-6357 jboisson@umn.edu

View on ClinicalTrials.gov More Temporomandibular Disorder (TMD) trials