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JIT: Effect of Pain on DT in TMD

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

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06659991
Acronym
TMD
Enrollment
160
Registered
2024-10-26
Start date
2025-05-14
Completion date
2029-09-07
Last updated
2026-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Temporomandibular Disorder (TMD)

Keywords

alcohol, temporomandibular disorder (TMD), chronic pain

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.

Interventions

DRUGalcohol condition

Ethanol

OTHERcontrol condition

sparkling water

Sponsors

University of Minnesota
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Masking description

This study does not employ masking.

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Alcohol Use Topography30 minutesVariables reflecting microstructure of alcohol use during self-administration, including sip interval and sip volume.
Heat Pain Intensity30 minutesPain intensity of heat stimuli applied during self- administration sessions.

Countries

United States

Contacts

CONTACTJeff Boissoneault
jboisson@umn.edu612-624-6357
PRINCIPAL_INVESTIGATORJeff Boissoneault

University of Minnesota

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 10, 2026