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New treatment option for Temporomandibular Disorder (TMD)
Official title JIT: Effect of Pain on DT in TMD
ClinicalTrials.gov ID: NCT06659991
What this study is testing
What is alcohol condition?
alcohol condition is an investigational medicine, given as an once-daily, being studied as a potential treatment for temporomandibular disorder (tmd).
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
- 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.
- 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); neurological disease (e.g., multiple sclerosis, epilepsy, amyotrophic...
- 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. Participants testing positive for any substance will be...
- Medications that contraindicate alcohol use
The study team makes the final eligibility decision.
Where it's taking place
- 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 - 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?
Study sites include Minneapolis, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.