RECRUITING

JIT: Effect of Pain on DT in TMD

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-04-07
Study Completion:2029-09-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06659991

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants in this study must be 21 years to 65 years of age and provide a driver's license or other state-issued ID.
  2. * Participants must also be sufficiently fluent in English to provide informed consent and understand questionnaires and instructions for laboratory procedures.
  3. * 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.
  4. * 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).
  5. * Own a smartphone with internet access.
  6. * Use of prescription medications will be allowed, provided they do not contraindicate alcohol use.
  1. * Use of opioid analgesics within the past month;
  2. * Current major depression;
  3. * History of any psychotic disorder;
  4. * Under-controlled hypertension or diabetes (as reflected by self-report); neurological disease (e.g., multiple sclerosis, epilepsy, amyotrophic lateral sclerosis, Parkinson's disease);
  5. * Serious medical illness (e.g., hepatitis, HIV/AIDS);
  6. * Impaired cognitive function;
  7. * History of substance use disorder (including nicotine/tobacco);
  8. * Alcohol naïve
  9. * Alcohol use disorder, or currently attempting to quit or cut down on using alcohol
  10. * Positive pregnancy test
  11. * Breastfeeding or intending to become pregnant
  12. * Loss of sensation in the lower leg
  13. * Inability to complete study tasks due to weakness, immobilization, or loss of limbs
  14. * Chronic pain (Control group only)
  15. * 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.
  16. * Medications that contraindicate alcohol use

Contacts and Locations

Study Contact

Jeff Boissoneault
CONTACT
612-624-6357
jboisson@umn.edu

Principal Investigator

Jeff Boissoneault
PRINCIPAL_INVESTIGATOR
University of Minnesota

Study Locations (Sites)

University of Minnesota
Minneapolis, Minnesota, 55414
United States

Collaborators and Investigators

Sponsor: University of Minnesota

  • Jeff Boissoneault, PRINCIPAL_INVESTIGATOR, University of Minnesota

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-07
Study Completion Date2029-09-07

Study Record Updates

Study Start Date2025-04-07
Study Completion Date2029-09-07

Terms related to this study

Keywords Provided by Researchers

  • alcohol
  • temporomandibular disorder (TMD)
  • chronic pain

Additional Relevant MeSH Terms

  • Temporomandibular Disorder (TMD)