JIT: Effect of Pain on DT in TMD (TMD)

February 10, 2026 updated by: University of Minnesota

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55414
        • Recruiting
        • University of Minnesota
        • Contact:
          • Jeff Boissoneault

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TMD Group 1
People with an established diagnosis of temporomandibular disorder (TMD) assigned to Ethanol intervention
Drug: alcohol condition
Ethanol
Sham Comparator: TMD Group 2
People with an established diagnosis of temporomandibular disorder (TMD) assigned to sparkling water (control)
Other: control condition
sparkling water
Experimental: Pain-free Control Group 1
People without an established diagnosis of temporomandibular disorder (TMD) or other chronic pain condition assigned to Ethanol intervention
Drug: alcohol condition
Ethanol
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)
Other: control condition
sparkling water

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alcohol Use Topography
Time Frame: 30 minutes
Variables reflecting microstructure of alcohol use during self-administration, including sip interval and sip volume.
30 minutes
Heat Pain Intensity
Time Frame: 30 minutes
Pain intensity of heat stimuli applied during self- administration sessions.
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Investigators

  • Principal Investigator: Jeff Boissoneault, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 14, 2025

Primary Completion (Estimated)

September 7, 2029

Study Completion (Estimated)

September 7, 2029

Study Registration Dates

First Submitted

October 24, 2024

First Submitted That Met QC Criteria

October 24, 2024

First Posted (Actual)

October 26, 2024

Study Record Updates

Last Update Posted (Actual)

February 12, 2026

Last Update Submitted That Met QC Criteria

February 10, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANES-2024-33184

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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