Temporomandibular Disorder study: Alcohol condition
Official title JIT: Effect of Pain on DT in TMD
ClinicalTrials.gov ID: NCT06659991
What this study is testing
What is alcohol condition?
This is an investigational study using ethanol to examine how chronic temporomandibular disorder (TMD) pain affects drinking habits.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find out whether having chronic jaw pain changes how much and how often people drink alcohol.
- Who it's for
- It looks for adults who drink heavily, with or without chronic temporomandibular disorder pain.
- What's involved
- Participants will be observed in a lab setting and monitored in their daily lives to record their drinking habits.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 65. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- 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...
- Own a smartphone with internet access.
You likely can't join if
- 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)
- Serious medical illness (e.g., hepatitis, HIV/AIDS);
- Impaired cognitive function;
See the full eligibility 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.
- 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.
- Medications that contraindicate alcohol use
The study team makes the final eligibility decision.
Where it is enrolling
- Minneapolis, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Minneapolis, Minnesota, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.