Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06659991

JIT: Effect of Pain on DT in TMD

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location status: Recruiting

Location contact

Jeff Boissoneault

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

alcohol condition

Drug

Ethanol

Control condition

Other

sparkling water

Primary outcomes

  1. Alcohol Use Topography

    Time frame: 30 minutes

    Variables reflecting microstructure of alcohol use during self-administration, including sip interval and sip volume.

  2. Heat Pain Intensity

    Time frame: 30 minutes

    Pain intensity of heat stimuli applied during self- administration sessions.

Study contacts

Contact information is provided by the study sponsor or research team.

Jeff Boissoneault

CONTACT

[email protected]

612-624-6357

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

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

Acronym: TMD

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Oct 26, 2024
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.