JIT: Effect of Pain on DT in TMD

University of Minnesota (UMN)

Status and phase: Enrolling; Early Phase 1

Conditions: Temporomandibular Disorder (TMD)

Treatments: Other: control condition; Drug: alcohol condition

Study type: Interventional

Funder types: Other

Identifiers

NCT06659991

ANES-2024-33184

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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 design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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160 participants in 4 patient groups

TMD Group 1

Experimental group

Description:

People with an established diagnosis of temporomandibular disorder (TMD) assigned to Ethanol intervention

Treatment:

Drug: alcohol condition

TMD Group 2

Sham Comparator group

Description:

People with an established diagnosis of temporomandibular disorder (TMD) assigned to sparkling water (control)

Treatment:

Other: control condition

Pain-free Control Group 1

Experimental group

Description:

People without an established diagnosis of temporomandibular disorder (TMD) or other chronic pain condition assigned to Ethanol intervention

Treatment:

Drug: alcohol condition

Pain-free Control Group 2

Sham Comparator group

Description:

People without an established diagnosis of temporomandibular disorder (TMD) or other chronic pain condition assigned to sparkling water (control)

Treatment:

Other: control condition