JIT: Effect of Pain on DT in TMD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: alcohol condition, control condition.
- Who it may be relevant to
- Registry conditions: Temporomandibular Disorder (TMD). Basic parameters: 21 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
JIT: Effects of Pain on Laboratory Drinking Topography and Daily Drinking in People With Chronic Temporomandibular Disorder (TMD) Pain
Overview
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.
Interventions
- Drug alcohol condition
Ethanol - Other control condition
sparkling water
Primary outcome measures
- Alcohol Use Topography [Time frame: 30 minutes]
- Heat Pain Intensity [Time frame: 30 minutes]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- University of Minnesota — Minneapolis
Identifiers
NCT: NCT06659991 · ANES-2024-33184