Clinical trial NCT06659991: JIT: Effect of Pain on DT in TMD
Official title: JIT: Effects of Pain on Laboratory Drinking Topography and Daily Drinking in People With Chronic Temporomandibular Disorder (TMD) Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Temporomandibular Disorder (TMD)
Keywords: alcohol
temporomandibular disorder (TMD)
chronic pain
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2024-10-26
Enrollment: 160
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a crossover design wherein participants consume either alcohol-containing beverages (beer or cider) or sparkling water over two laboratory sessions.
Primary purpose: BASIC_SCIENCE

Brief 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.


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 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

Primary outcomes:
measure: Alcohol Use Topography
timeFrame: 30 minutes
measure: Heat Pain Intensity
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Jeff Boissoneault
role: PRINCIPAL_INVESTIGATOR
References: