Recruiting
Early Phase 1

Observational Study

Sponsor:

University of Minnesota

Code:

NCT06659991

Conditions

Temporomandibular Disorder (TMD)

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Accepted

Interventions

alcohol condition

control condition

Study Details

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.

Conditions

Temporomandibular Disorder (TMD)

Study ID

NCT06659991

Start date

May 14, 2025

Status verified date

Jul, 2026

Completion date

Sep 7, 2029

Anticipated

Primary completion date

Sep 7, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Accepted

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 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

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

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)

Interventions

alcohol condition

Ethanol

control condition

sparkling water

Primary outcome measure

  • Alcohol Use Topography [ Time Frame: 30 minutes ]
  • Heat Pain Intensity [ Time Frame: 30 minutes ]

Central Contacts and Locations

Central contacts

Jeff Boissoneault

612-624-6357jboisson@umn.edu

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55414

More Information

Sponsor

University of Minnesota

Last update posted

Jul 9, 2026

Last verified

Jul, 2026

Keywords

  • alcohol
  • temporomandibular disorder (TMD)
  • chronic pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-07-09.