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

Trial Summary

What is the purpose of 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.

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.

What data supports the effectiveness of alcohol consumption as a treatment for jaw pain?

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 provides pain relief. Moderate alcohol use is associated with positive pain-related outcomes, while excessive drinking can worsen pain severity. ^{1 2 3 4 5}

Is alcohol consumption safe for treating jaw pain?

The research articles provided do not contain specific safety data on alcohol consumption for treating jaw pain. ^{6 7 8 9 10}

How does alcohol consumption differ from other treatments for jaw pain?

Alcohol consumption for jaw pain is unique because it relies on the individual's expectation that alcohol will relieve pain, rather than directly altering pain thresholds or intensity. This psychological aspect of expecting pain relief is a key factor in its perceived effectiveness, setting it apart from other treatments that typically focus on physiological mechanisms. ^{2 4 11 12 13}

Research Team

Jeff Boissoneault

Principal Investigator

University of Minnesota

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Interrelations between pain and alcohol: An integrative review. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Sensory-motor response elicited by first time intraoral administered ethanol after trigeminal neuropathic injury. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Self-report of alcohol use for pain in a multi-ethnic community sample. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Expectancy of alcohol analgesia moderates perception of pain relief following acute alcohol intake. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Emotional distress and medication use in two acute pain populations: jaw and low back. [2015]

6. United States pubmed.ncbi.nlm.nih.gov

Chronic Pain-Related Jaw Muscle Motor Load and Sensory Processing. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Prevalence of Temporomandibular Disorder Symptoms and Their Association with Alcohol and Smoking Habits. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Associations Between Temporomandibular Pain and Biobehavioral Variables in Dental Students in Response to an External Stressor. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Tooth Clenching Until Exhaustion Evokes Exercise-Induced Hypoalgesia in Healthy Persons and in Patients with Temporomandibular Disorders. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Effects of Acute Experimental Stress on Pain Sensitivity and Cortisol Levels in Healthy Participants: A Randomized Crossover Pilot Study. [2021]

11. Japan pubmed.ncbi.nlm.nih.gov

Effect of alcohol consumption status and alcohol concentration on oral pain induced by alcohol-containing mouthwash. [2019]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of ethanol on deep pain evoked by formalin injected in TMJ of rat. [2019]

13. United States pubmed.ncbi.nlm.nih.gov

Experimental occlusal interference induces long-term masticatory muscle hyperalgesia in rats. [2022]