JIT: Effect of Pain on DT in TMD

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
University of Minnesota
Study ID
NCT06659991
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Temporomandibular Disorder (TMD)

Eligibility Criteria

Sex
ALL
Age
21 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • alcohol condition — DRUG
    Ethanol
  • control condition — OTHER
    sparkling water

Study Details

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.

Key Dates

Start date
May 14, 2025
Status verified
Feb 2026
Primary completion
Sep 7, 2029
Completion
Sep 7, 2029

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: TMD Group 1
    People with an established diagnosis of temporomandibular disorder (TMD) assigned to Ethanol intervention
  • Sham Comparator: TMD Group 2
    People with an established diagnosis of temporomandibular disorder (TMD) assigned to sparkling water (control)
  • Experimental: Pain-free Control Group 1
    People without an established diagnosis of temporomandibular disorder (TMD) or other chronic pain condition assigned to Ethanol intervention
  • Sham Comparator: Pain-free Control Group 2
    People without an established diagnosis of temporomandibular disorder (TMD) or other chronic pain condition assigned to sparkling water (control)

Primary Outcome Measure

Alcohol Use Topography [ Time Frame: 30 minutes ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MinnesotaMinneapolisMinnesota55414
Jeff Boissoneault

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By research site
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