Examining how pain affects drinking habits in people with temporomandibular disorder
JIT: Effects of Pain on Laboratory Drinking Topography and Daily Drinking in People With Chronic Temporomandibular Disorder (TMD) Pain
EARLY_PHASE1 · University of Minnesota · NCT06659991
This study is trying to see how chronic pain from jaw problems affects drinking habits in heavy drinkers.
Quick facts
| Phase | EARLY_PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 21 Years to 65 Years |
| Sex | All |
| Sponsor | University of Minnesota (other) |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT06659991 on ClinicalTrials.gov |
What this trial studies
This study investigates the relationship between chronic pain from temporomandibular disorder (TMD) and alcohol consumption patterns in heavy drinkers. It aims to understand how pain influences drinking behavior both in controlled laboratory settings and in participants' daily lives. By comparing individuals with TMD pain to those without, the study seeks to identify modifiable and non-modifiable risk factors associated with alcohol use. Participants will be monitored under different conditions to assess their drinking topography.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 to 65 who regularly exceed alcohol consumption guidelines and have been diagnosed with temporomandibular disorder.
Not a fit: Patients who do not consume alcohol regularly or have a history of major depression or psychotic disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved interventions for managing alcohol use in individuals suffering from chronic pain conditions like TMD.
How similar studies have performed: While there is limited systematic examination of this specific relationship, previous studies have indicated a connection between chronic pain and increased alcohol use, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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 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
Where this trial is running
Minneapolis, Minnesota
- University of Minnesota — Minneapolis, Minnesota, United States (RECRUITING)
Study contacts
- Principal investigator: Jeff Boissoneault — University of Minnesota
- Study coordinator: Jeff Boissoneault
- Email: jboisson@umn.edu
- Phone: 612-624-6357
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Temporomandibular Disorder, alcohol, temporomandibular disorder, chronic pain