Alcohol Consumption for Jaw Pain

(TMD Trial)

Overseen By Jeff Boissoneault

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Minnesota

Must not be taking: Opioids, Benzodiazepines, Morphine, others

Disqualifiers: Depression, Psychotic disorder, Hypertension, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how jaw pain affects alcohol consumption patterns in heavy drinkers. Researchers will compare individuals with chronic jaw pain, known as temporomandibular disorder (TMD), to those without any chronic pain. Participants will consume either alcohol or a non-alcoholic beverage (sparkling water) to observe how pain influences drinking habits. Suitable candidates include those diagnosed with TMD, who drink regularly, and whose jaw pain impacts their daily life. As an Early Phase 1 trial, this research focuses on understanding how the condition affects behavior, offering participants an opportunity to contribute to foundational knowledge.

Will I have to stop taking my current medications?

You can continue taking your current medications as long as they do not have a negative interaction with alcohol. If your medication does not mix well with alcohol, you may need to stop taking it to participate in the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that alcohol can reduce the intensity of pain and raise the pain threshold, making pain less noticeable or easier to handle. However, individuals with long-term jaw pain, known as temporomandibular disorder (TMD), often experience more alcohol-related problems than those without this condition.

Studies have found that drinking alcohol once a week is linked to increased facial and jaw pain. While alcohol might seem to alleviate pain, it could actually lead to more pain issues, especially for those with TMD.

The trial is in its early stages. Although some understanding exists of how alcohol affects pain, more research is needed to determine its safety for people with TMD. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the potential of ethanol as a treatment for temporomandibular disorder (TMD) because it offers a novel approach to pain management. Unlike traditional treatments for TMD, which often involve muscle relaxants, anti-inflammatory drugs, or physical therapy, ethanol might directly modulate pain perception, potentially offering quicker relief. Additionally, exploring ethanol's effects on jaw pain could uncover new insights into how alcohol influences pain pathways, setting the stage for innovative therapies. This unique angle has the potential to broaden our understanding of pain management in TMD and other chronic pain conditions.

What evidence suggests that this trial's treatments could be effective for jaw pain?

This trial will compare the effects of alcohol consumption on jaw pain in different groups. Research has shown that alcohol can reduce pain for individuals with chronic jaw pain. Studies have found that alcohol consumption can significantly lessen the intensity and unpleasantness of pain. In this trial, some participants with chronic temporomandibular disorder (TMD) will receive an ethanol intervention, while others will be assigned to a control group receiving sparkling water. Individuals with chronic TMD often experience less pain after consuming alcohol. However, it is important to note that while alcohol might provide short-term relief, regular use for pain management can lead to other health risks, including increased consumption over time. ^{1 2 3 6 7}

Who Is on the Research Team?

Jeff Boissoneault

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for adults aged 21-65 with chronic jaw pain from Temporomandibular Disorder (TMD) who drink alcohol more than the recommended guidelines. They must be able to understand English, have a smartphone with internet, and take medications that don't interfere with alcohol.

Inclusion Criteria

I am between 21 and 65 years old and can show a valid ID.

My medications are safe to use with alcohol.

I can speak and understand English well enough to give informed consent and follow study instructions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Laboratory Assessment

Participants undergo laboratory sessions to assess the effect of pain on drinking topography

30 minutes per session

Multiple sessions

Daily Life Assessment

Participants' drinking behavior is monitored in daily life settings

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after the assessments

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Pain modulation

Trial Overview The study examines how jaw pain affects drinking behavior in heavy drinkers with TMD. Participants will experience two conditions: one involving alcohol and another as a control to compare their drinking patterns in the lab and daily life.

How Is the Trial Designed?

Group I: TMD Group 1 Experimental Treatment 1 Intervention

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

Group II: Pain-free Control Group 1 Experimental Treatment 1 Intervention

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

Group III: Pain-free Control Group 2 Placebo Group 1 Intervention

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

Group IV: TMD Group 2 Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9427671/

Analgesic effects of alcohol in adults with chronic jaw pain Results: Analyses indicated significant increases in pain threshold and pain relief, as well as reductions in pain unpleasantness and pain intensity, under the ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06659991

NCT06659991 | JIT: Effect of Pain on DT in TMD Individuals with chronic temporomandibular disorder (TMD) pain are at increased risk for alcohol-related consequences compared to those without pain, and ...

3. withpower.com withpower.com/trial/early-phase-1-temporomandibular-joint-dysfunction-syndrome-2025-f0c6c

Alcohol Consumption for Jaw Pain (TMD Trial) Research suggests that alcohol can reduce pain intensity and increase pain threshold, but the perceived pain relief may be influenced by the belief that alcohol ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28118418/

Prevalence of Temporomandibular Disorder Symptoms ... Consumption of alcohol at least once a week was associated significantly with facial pain, TMJ pain, TMJ pain at jaw rest, TMJ pain on jaw movement, and TMJ ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2772724624000519

Determinants of perceived pain relief from acute alcohol ... Pain self-management with alcohol may lead to chronic heavy drinking, increasing the risk developing or worsening pain and other adverse health outcomes, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10795287/

Prevalence of Bruxism in alcohol abusers: a systematic review ... This systematic review will contribute to a better understanding of the interplay between bruxism and alcohol abuse, shedding light on potential risk factors.

7. researchgate.net researchgate.net/publication/396495220_Ibudilast_Attenuates_the_Association_Between_Pain_Intensity_and_Heavy_Drinking_in_Alcohol_Use_Disorder_A_Secondary_Analysis_of_a_Randomized_Clinical_Trial

A Secondary Analysis of a Randomized Clinical Trial Most physiological studies interested in alcohol-dependence examined ethanol as a pharmacological agent rather than a nutrient. We conducted two ...