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NCT06659991 | NOT YET RECRUITING | Temporomandibular Disorder (TMD)

JIT: Effect of Pain on DT in TMD
Sponsor:

University of Minnesota

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.

Condition or disease

Temporomandibular Disorder (TMD)

Intervention/treatment

alcohol condition

control condition

Phase

EARLY_PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 160 participants
Masking : NONE
Masking Description : This study does not employ masking.
Primary Purpose : BASIC_SCIENCE
Official Title : JIT: Effects of Pain on Laboratory Drinking Topography and Daily Drinking in People With Chronic Temporomandibular Disorder (TMD) Pain
Actual Study Start Date : 2025-01-02
Estimated Primary Completion Date : 2029-05-30
Estimated Study Completion Date : 2029-05-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 21 Years to 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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 in this study must report regular drinking exceeding NIAAA guidelines for (≥ 2 (men) or ≥ 1 (women) drinks per day on average) over the past six months, as well as drinking on ≥ 2 days/week.
  • * 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
JIT: Effect of Pain on DT in TMD

Location Details

NCT06659991

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