Acute Effects of Alcohol Use on Chronic Orofacial Pain

Study Overview
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Brief Summary
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Self-medication of pain with alcohol is a common, yet risky, behavior among individuals with chronic orofacial pain. Chronic pain status may affect the degree to which alcohol use relieves pain, but the independent contributions of pain chronification and alcohol-related expectations and conditioning have not been previously studied. This project addresses this gap in knowledge and will inform further research and clinical/translational efforts for reducing risk associated with these behaviors.

Official Title
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Acute Effects of Alcohol Use on Chronic Orofacial Pain

Conditions
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Temporomandibular Joint Disorders

Intervention / Treatment
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* Drug: Ethanol
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Positive diagnosis of jaw pain, including temporomandibular joint and muscle disorder (TMD) (jaw pain group only) Consume at least 1 drink/month over the past 6 months Exclusion Criteria: History of chronic pain other than jaw pain or TMD Current use of opioids Current major depression History of any psychotic disorder Undercontrolled hypertension or diabetes History of neurologic disease History of serious medical illness History of drug or alcohol dependence, including nicotine, or a pattern of hazardous alcohol use

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: People with and without jaw pain, including temporomandibular joint and muscle disorder (TMD) will receive an active oral dose of alcohol or placebo in a counterbalanced manner.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Jaw pain patients<br>Individuals seeking care for jaw pain, including temporomandibular joint and muscle disorder (TMD). | Drug: Ethanol<br>* A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.<br>Other: Placebo<br>* A beverage that does not meaningfully increase breath alcohol concentration.<br>|
| Experimental: Healthy controls<br>Healthy social drinkers without jaw pain recruited as a comparison group. | Drug: Ethanol<br>* A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.<br>Other: Placebo<br>* A beverage that does not meaningfully increase breath alcohol concentration.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pressure Pain Threshold | Pressure at which stimulation at the masseter insertion becomes painful, in lbf. Positive values represent higher pain thresholds. | Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.) | 
| Pressure Pain Intensity | Pain ratings associated with 4, 5, or 6 pound-feet (lbf) of pressure applied to the insertion of the masseter. VAS (visual analogue scale) pain intensity ratings anchored from 0 (no pain at all) to 100 (most intense imaginable) were collected. Higher values represent higher pain intensity. | Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.) | 
| Perceived Relief | Ratings of relief from pain associated with consumption of the study beverage following application of 4, 5, or 6 lbf stimuli. VAS (visual analogue scale) assessing perceived relief anchored from 0 (No relief at all) to 100 (Most profound relief imaginable). Higher values represent greater perceived relief. | Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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alcohol effects