An interventional study of Ethanol and Placebo in Temporomandibular Joint Disorders, sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 21 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-27.
Sponsored by University of Florida · Not applicable, Interventional, and Basic science
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.
609 studies on the registry are indexed under Temporomandibular Joint Disorders; 160 are open to participants now.
This study's enrollment of 48 is close to the median of 46 across 434 interventional studies indexed under Temporomandibular Joint Disorders.
Browse Temporomandibular Joint Disorders studies →University of Florida is the lead sponsor of 1,254 studies on the registry; 201 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 136 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Individuals seeking care for jaw pain, including temporomandibular joint and muscle disorder (TMD).
Drug: Ethanol · Other: Placebo
Healthy social drinkers without jaw pain recruited as a comparison group.
Drug: Ethanol · Other: Placebo
A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.
A beverage that does not meaningfully increase breath alcohol concentration.
Pressure Pain Threshold
Pressure at which stimulation at the masseter insertion becomes painful, in lbf. Positive values represent higher pain thresholds.
Time frame: 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.
Time frame: 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.
Time frame: Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.)
| Milestone | Jaw Pain Patients: Ethanol First, Then Placebo | Healthy Controls: Ethanol First, Then Placebo | Jaw Pain Patients: Placebo First, Then Ethanol | Healthy Controls: Placebo First, Then Ethanol |
|---|---|---|---|---|
| Started | 9 | 16 | 10 | 13 |
| Completed | 9 | 16 | 10 | 13 |
| Not completed | 0 | 0 | 0 | 0 |
Pressure at which stimulation at the masseter insertion becomes painful, in lbf. Positive values represent higher pain thresholds.
| lbf | Jaw Pain Patients: Ethanol | Healthy Controls: Ethanol | Jaw Pain Patients: Placebo | Healthy Controls: Placebo |
|---|---|---|---|---|
| Pressure Pain Threshold | 4.56 ± 1.08 | 5.27 ± 1.37 | 3.81 ± 0.84 | 4.51 ± 1.21 |
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.
| VAS units | Jaw Pain Patients: Ethanol, 4lbf | Healthy Controls: Ethanol, 4lbf | Jaw Pain Patients: Placebo, 4lbf | Healthy Controls: Placebo, 4lbf | Jaw Pain Patients: Ethanol, 5lbf | Healthy Controls: Ethanol, 5lbf | Jaw Pain Patients: Placebo, 5lbf | Healthy Controls: Placebo, 5lbf | Jaw Pain Patients: Ethanol, 6lbf | Healthy Controls: Ethanol, 6lbf | Jaw Pain Patients: Placebo, 6lbf | Healthy Controls: Placebo, 6lbf |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pressure Pain Intensity | 23.96 ± 28.03 | 12.76 ± 13.44 | 32.39 ± 19.95 | 22.05 ± 17.72 | 35.43 ± 19.67 | 20.92 ± 17.02 | 41.81 ± 20.28 | 29.98 ± 23.89 | 37.19 ± 23.90 | 26.95 ± 23.06 | 46.10 ± 22.97 | 34.03 ± 22.94 |
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.
| VAS units | Jaw Pain Patients: Ethanol, 4lbf | Healthy Controls: Ethanol, 4lbf | Jaw Pain Patients: Placebo, 4lbf | Healthy Controls: Placebo, 4lbf | Jaw Pain Patients: Ethanol, 5lbf | Healthy Controls: Ethanol, 5lbf | Jaw Pain Patients: Placebo, 5lbf | Healthy Controls: Placebo, 5lbf | Jaw Pain Patients: Ethanol, 6lbf | Healthy Controls: Ethanol, 6lbf | Jaw Pain Patients: Placebo, 6lbf | Healthy Controls: Placebo, 6lbf |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Perceived Relief | 40.58 ± 31.31 | 39.79 ± 30.58 | 7.91 ± 13.71 | 5.51 ± 11.36 | 41.00 ± 28.27 | 42.75 ± 30.14 | 7.20 ± 13.01 | 5.57 ± 11.13 | 39.72 ± 30.05 | 43.65 ± 29.61 | 7.20 ± 13.41 | 5.89 ± 13.11 |
Collected over Duration of study participation (4-8 hours per study session, with at least 48 hours separating each session). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Jaw Pain Patients: Ethanol | 0/19 (0%) | 0/19 (0%) | 0/19 (0%) |
| Healthy Controls: Ethanol | 0/29 (0%) | 0/29 (0%) | 1/29 (3.4%) |
| Jaw Pain Patients: Placebo | 0/19 (0%) | 0/19 (0%) | 0/19 (0%) |
| Healthy Controls: Placebo | 0/29 (0%) | 0/29 (0%) | 0/29 (0%) |
| Event | Jaw Pain Patients: Ethanol | Healthy Controls: Ethanol | Jaw Pain Patients: Placebo | Healthy Controls: Placebo |
|---|---|---|---|---|
| Nausea and vomitingGastrointestinal disorders | 0/19 | 1/29 | 0/19 | 0/29 |
| Age, Continuous(years) | Jaw Pain Patients | Healthy Controls | Total |
|---|---|---|---|
| Mean | 26.74 ± 5 | 25.72 ± 4.12 | 26.13 ± 4.47 |
| Sex: Female, Male(Participants) | Jaw Pain Patients | Healthy Controls | Total |
|---|---|---|---|
| Female | 17 | 19 | 36 |
| Male | 2 | 10 | 12 |
| Ethnicity (NIH/OMB)(Participants) | Jaw Pain Patients | Healthy Controls | Total |
|---|---|---|---|
| Hispanic or Latino | 4 | 9 | 13 |
| Not Hispanic or Latino | 15 | 20 | 35 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Jaw Pain Patients | Healthy Controls | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 4 | 6 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 3 | 3 |
| White | 12 | 17 | 29 |
| More than one race | 5 | 5 | 10 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Jaw Pain Patients | Healthy Controls | Total |
|---|---|---|---|
| United States | 19 | 29 | 48 |
| Alcohol Use Disorders Identification Test (total score)(units on a scale) | Jaw Pain Patients | Healthy Controls | Total |
|---|---|---|---|
| Mean | 4.37 ± 1.77 | 4.31 ± 1.67 | 4.33 ± 1.69 |
| Quantity-Frequency Index(oz. absolute ethanol consumed per day) | Jaw Pain Patients | Healthy Controls | Total |
|---|---|---|---|
| Mean | .426 ± .35 | .551 ± .39 | .48 ± .36 |
| Max Quantity (oz. abs. EtOH)(oz. absolute ethanol) | Jaw Pain Patients | Healthy Controls | Total |
|---|---|---|---|
| Mean | 4.29 ± 2.01 | 3.74 ± 1.41 | 3.96 ± 1.67 |
1 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
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Temporomandibular Joint Disorders→
University of Florida