JIT: Effect of Pain on DT in TMD

NCT06659991 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: ANES-2024-33184
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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)

Keywords

alcohol; temporomandibular disorder (TMD); chronic pain

Outcome Measures

Primary Outcomes (2)

• Alcohol Use Topography

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

  30 minutes

• Heat Pain Intensity

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

  30 minutes

Study Arms (4)

TMD Group 1

EXPERIMENTAL

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

Drug: alcohol condition

TMD Group 2

SHAM COMPARATOR

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

Other: control condition

Pain-free Control Group 1

EXPERIMENTAL

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

Drug: alcohol condition

Pain-free Control Group 2

SHAM COMPARATOR

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

Other: control condition

Interventions

alcohol condition DRUG

Ethanol

Pain-free Control Group 1; TMD Group 1

control condition OTHER

sparkling water

Pain-free Control Group 2; TMD Group 2

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55414, United States

RECRUITING

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Chronic Pain

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Jeff Boissoneault

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeff Boissoneault

CONTACT

612-624-6357; jboisson@umn.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This study does not employ masking.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a crossover design wherein participants consume either alcohol-containing beverages (beer or cider) or sparkling water over two laboratory sessions.

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: October 26, 2024
• Study Start: May 14, 2025
• Primary Completion (Estimated): September 7, 2029
• Study Completion (Estimated): September 7, 2029
• Last Updated: February 12, 2026

Record last verified: 2026-02

Locations

US (1)