JIT: Effect of Pain on DT in TMD

NCT ID: NCT06659991

Last Updated: 2026-02-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-14
• Study Completion Date: 2029-09-07

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

TMD Group 1

People with an established diagnosis of temporomandibular disorder (TMD) assigned to Ethanol intervention

Group Type: EXPERIMENTAL

alcohol condition

Intervention Type: DRUG

Ethanol

TMD Group 2

People with an established diagnosis of temporomandibular disorder (TMD) assigned to sparkling water (control)

Group Type: SHAM_COMPARATOR

control condition

Intervention Type: OTHER

sparkling water

Pain-free Control Group 1

People without an established diagnosis of temporomandibular disorder (TMD) or other chronic pain condition assigned to Ethanol intervention

Group Type: EXPERIMENTAL

alcohol condition

Intervention Type: DRUG

Ethanol

Pain-free Control Group 2

People without an established diagnosis of temporomandibular disorder (TMD) or other chronic pain condition assigned to sparkling water (control)

Group Type: SHAM_COMPARATOR

control condition

Intervention Type: OTHER

sparkling water

Interventions

alcohol condition

Ethanol

Intervention Type: DRUG

control condition

sparkling water

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeff Boissoneault

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jeff Boissoneault

Role: CONTACT

jboisson@umn.edu

612-624-6357

Facility Contacts

Jeff Boissoneault

Role: primary

Other Identifiers

ANES-2024-33184

Identifier Type: -

Identifier Source: org_study_id