JIT: Effect of Pain on DT in TMD
Purpose
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
- Temporomandibular Disorder (TMD)
Eligibility
- Eligible Ages
- Between 21 Years and 65 Years
- Eligible Sex
- 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
- 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
Study Design
- Phase
- Early Phase 1
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover Assignment
- 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.
- Primary Purpose
- Basic Science
- Masking
- None (Open Label)
- Masking Description
- This study does not employ masking.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental TMD Group 1 |
People with an established diagnosis of temporomandibular disorder (TMD) assigned to Ethanol intervention |
|
|
Sham Comparator TMD Group 2 |
People with an established diagnosis of temporomandibular disorder (TMD) assigned to sparkling water (control) |
|
|
Experimental Pain-free Control Group 1 |
People without an established diagnosis of temporomandibular disorder (TMD) or other chronic pain condition assigned to Ethanol intervention |
|
|
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) |
|
Recruiting Locations
University of Minnesota
Minneapolis 5037649, Minnesota 5037779 55414
Minneapolis 5037649, Minnesota 5037779 55414
Contact:
Jeff Boissoneault
Jeff Boissoneault
More Details
- Status
- Recruiting
- Sponsor
- University of Minnesota