JIT: Effect of Pain on DT in TMD

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	21 Years - 65 Years
Gender	All

More 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 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.

- 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06659991
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Early Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Minnesota
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Jeff Boissoneault
Principal Investigator Affiliation	University of Minnesota
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Temporomandibular Disorder (TMD)

Arms & Interventions

Arms

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)

Interventions

Drug: - alcohol condition

Ethanol

Other: - control condition

sparkling water

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Minnesota, Minneapolis, Minnesota

Status

Recruiting

Address

University of Minnesota

Minneapolis, Minnesota, 55414

Site Contact

Jeff Boissoneault

[email protected]

612-624-6357

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