JIT: Effect of Pain on DT in TMD (NCT06659991) | Clinical Trial Compass
RecruitingEarly Phase 1
JIT: Effect of Pain on DT in TMD
United States160 participantsStarted 2025-05-14
Plain-language 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.
Who can participate
Age range21 Years – 65 Years
SexALL
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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 l…