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Recruiting EARLY_Phase 1 NCT06659991

NCT06659991 JIT: Effect of Pain on DT in TMD

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Clinical Trial Summary
NCT ID NCT06659991
Status Recruiting
Phase EARLY_Phase 1
Sponsor University of Minnesota
Condition Temporomandibular Disorder (TMD)
Study Type INTERVENTIONAL
Enrollment 160 participants
Start Date 2025-05-14
Primary Completion 2029-09-07

Trial Parameters

Condition Temporomandibular Disorder (TMD)
Sponsor University of Minnesota
Study Type INTERVENTIONAL
Phase EARLY_Phase 1
Enrollment 160
Sex ALL
Min Age 21 Years
Max Age 65 Years
Start Date 2025-05-14
Completion 2029-09-07
Interventions
alcohol conditioncontrol condition

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Brief 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.

Eligibility Criteria

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, epi

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