CClinicalTrials.gg
Sign In
RecruitingNCT06659991TMDUpdated Jul 9, 2026

JIT: Effect of Pain on DT in TMD

An Early Phase 1 interventional study of alcohol condition and control condition in Temporomandibular Disorder (TMD), sponsored by University of Minnesota. Recruiting at 1 site in United States. Open to participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-09.

Sponsored by University of Minnesota · Early Phase 1, Interventional, and Basic science

From the registry’s dates

  • Started May 2025; still recruiting 1 year 4 months later.
Phase
Early Phase 1
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
21 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Temporomandibular Disorder (TMD)

Keywords

  • alcohol
  • temporomandibular disorder (TMD)
  • chronic pain
03

In context

Temporomandibular Joint Disorders

609 studies on the registry are indexed under Temporomandibular Joint Disorders; 160 are open to participants now.

This study's planned enrollment of 160 is above the median of 46 across 434 interventional studies indexed under Temporomandibular Joint Disorders.

Browse Temporomandibular Joint Disorders studies →

Lead sponsor

University of Minnesota is the lead sponsor of 1,184 studies on the registry; 195 are open to participants now.

Of its 132 completed or terminated interventional studies of FDA-regulated products, 91 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 65 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
160 participants (estimated)

Study arms

  • Experimental
    TMD Group 1

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

    Drug: alcohol condition

  • Sham comparator
    TMD Group 2

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

    Other: control condition

  • Experimental
    Pain-free Control Group 1

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

    Drug: alcohol condition

  • Sham comparator
    Pain-free Control Group 2

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

    Other: control condition

Interventions

  • Drugalcohol condition

    Ethanol

  • Othercontrol condition

    sparkling water

06

What researchers measure

Primary outcomes

  1. Alcohol Use Topography

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

    Time frame: 30 minutes

  2. Heat Pain Intensity

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

    Time frame: 30 minutes

07

Study locations

1 of 1 sites recruiting
  • University of Minnesota
    Minneapolis, Minnesota 55414, United States
    • Jeff Boissoneault · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06659991
Lead sponsor
University of Minnesota
Responsible party
Sponsor
First posted
Oct 26, 2024
Start date
May 14, 2025
Primary completion
Sep 7, 2029 (estimated)
Completion
Sep 7, 2029 (estimated)
Last update
Jul 9, 2026

Study contacts

Jeff Boissoneault
Contact
jboisson@umn.edu
612-624-6357
Jeff Boissoneault
principal investigator · University of Minnesota

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Temporomandibular Joint Disorders→

Other studies from this sponsor

University of Minnesota

Start the discussion