Actively Recruiting

Early Phase 1
Age: 21Years - 65Years
All Genders
Healthy Volunteers
ID06659991

JIT: Effects of Pain on Laboratory Drinking Topography and Daily Drinking in People With Chronic Temporomandibular Disorder (TMD) Pain

Led by University of Minnesota · Updated on 2026-02-12

160

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying how chronic temporomandibular disorder (TMD) pain affects drinking patterns in heavy drinkers. This study compares individuals with and without chronic TMD pain to understand how pain influences alcohol use, both in a laboratory setting and during daily life. It aims to fill gaps in knowledge about risk factors related to pain and alcohol consumption. Participants are assigned to one of four groups based on TMD diagnosis and the type of drink given: ethanol (alcohol) or sparkling water as a control. The groups include people with TMD who receive ethanol, people with TMD who receive sparkling water, people without TMD or chronic pain who receive ethanol, and people without TMD or chronic pain who receive sparkling water. This randomized study evaluates drinking behaviors and pain responses during the interventions. During the study, participants will be observed for alcohol use patterns and heat pain intensity over 30 minutes. They will complete questionnaires and laboratory procedures, and researchers will monitor drinking topography and pain levels. The study runs from May 2025 to September 2029, involving adults aged 21 to 65 who regularly consume alcohol. Safety and adherence are monitored, and assessments occur in both controlled and daily environments to capture real-world drinking behavior.

CONDITIONS

Brief Title

JIT: Effect of Pain on DT in TMD

Who Can Participate

Age: 21Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants must be 21 to 65 years old and provide a valid state-issued ID
  • Must be fluent in English to consent and follow study instructions
  • Must drink alcohol, averaging at least 1 drink 3 days per week over the past 6 months
  • For TMD group: must meet diagnostic criteria for myalgia, arthralgia, or both
  • Must own a smartphone with internet access
  • Prescription medication use allowed if not contraindicating alcohol use
Not Eligible

You will not qualify if you...

  • Use of opioid painkillers within the past month
  • Current major depression
  • History of any psychotic disorder
  • Under-controlled hypertension or diabetes
  • Neurological diseases such as multiple sclerosis, epilepsy, ALS, or Parkinson's
  • Serious medical illnesses like hepatitis or HIV/AIDS
  • Impaired cognitive function
  • History of substance use disorder, including nicotine/tobacco
  • Alcohol naive or currently trying to quit or reduce alcohol use
  • Positive pregnancy test, breastfeeding, or planning pregnancy
  • Loss of sensation in the lower leg
  • Inability to complete study tasks due to weakness or limb loss
  • Chronic pain in control group
  • Positive urine drug screen for certain substances
  • Use of medications that contraindicate alcohol use

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Short-term sessions during the study period

Participants receive either ethanol or sparkling water in a randomized crossover design while their drinking behavior and pain response are measured.

Multiple visits corresponding to each intervention session

Trial Site Locations

Total: 1 location

1

University of Minnesota

Minneapolis, Minnesota, United States, 55414

Actively Recruiting

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Research Team

J

Jeff Boissoneault

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

4

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