JIT: Effect of Pain on DT in TMD

ConditionTemporomandibular Disorder (TMD)

Trial statusRecruiting

Trial phaseEarly Phase 1

Trial typeInterventional

Biological sexAll

Age21-65

SponsorUniversity of Minnesota

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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).

Disqualifiers

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);

Trial design

Design model

Crossover

Treatments tested in this trial

alcohol condition
Drug
Ethanol
control condition
Other intervention
sparkling water

Treatment groups

160 Participants

are divided into 4 treatment groups

Group A: TMD Group 1Experimental treatment 1 intervention

Group B: TMD Group 2Sham comparator 1 intervention

Group C: Pain-free Control Group 1Experimental treatment 1 intervention

Group D: Pain-free Control Group 2Sham comparator 1 intervention

Trial outcomes

Primary outcomes

Alcohol Use Topography

Variables reflecting microstructure of alcohol use during self-administration, including sip interval and sip volume.

Time frame

30 minutes

Heat Pain Intensity

Pain intensity of heat stimuli applied during self- administration sessions.

Time frame

30 minutes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Minnesota

Lead sponsor

Source ClinicalTrials.gov

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