Acute Effects of Alcohol Use on Chronic Orofacial Pain (NCT04019093) | Clinical Trial Compass
CompletedNot Applicable
Acute Effects of Alcohol Use on Chronic Orofacial Pain
United States48 participantsStarted 2019-11-05
Plain-language summary
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.
Who can participate
Age range
21 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pressure Pain Threshold
Timeframe: Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.)
2
Pressure Pain Intensity
Timeframe: Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.)
3
Perceived Relief
Timeframe: Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.)