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| ID | Type | Description | Link |
|---|---|---|---|
| R21AA026805 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Jaw pain patients | Experimental | Individuals seeking care for jaw pain, including temporomandibular joint and muscle disorder (TMD). |
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| Healthy controls | Experimental | Healthy social drinkers without jaw pain recruited as a comparison group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ethanol | Drug | A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. |
|
| 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.) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeff Boissoneault, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Pain Research and Behavioral Health at UF Health | Gainesville | Florida | 32610 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37358545 | Derived | Alexander C, Bush NJ, Neubert JK, Robinson M, Boissoneault J. Expectancy of alcohol analgesia moderates perception of pain relief following acute alcohol intake. Exp Clin Psychopharmacol. 2024 Apr;32(2):228-235. doi: 10.1037/pha0000664. Epub 2023 Jun 26. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Jaw Pain Patients: Ethanol First, Then Placebo | Individuals seeking care for jaw pain, including temporomandibular joint and muscle disorder (TMD), randomized to receive ethanol first, followed by placebo. The first laboratory session lasted 4-8 hours, followed by a minimum 48 hour gap, and the second laboratory session lasted 4-8 hours. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration. |
| FG001 | Healthy Controls: Ethanol First, Then Placebo | Healthy social drinkers without jaw pain recruited as a comparison group who received ethanol first, randomized to receive ethanol first, followed by placebo. The first laboratory session lasted 4-8 hours, followed by a minimum 48 hour gap, and the second laboratory session lasted 4-8 hours. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration. |
| FG002 | Jaw Pain Patients: Placebo First, Then Ethanol | Individuals seeking care for jaw pain, including temporomandibular joint and muscle disorder (TMD), randomized to receive placebo first, followed by ethanol. The first laboratory session lasted 4-8 hours, followed by a minimum 48 hour gap, and the second laboratory session lasted 4-8 hours. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration. |
| FG003 | Healthy Controls: Placebo First, Then Ethanol | Healthy social drinkers without jaw pain recruited as a comparison group who received ethanol first, randomized to receive placebo first, followed by ethanol. The first laboratory session lasted 4-8 hours, followed by a minimum 48 hour gap, and the second laboratory session lasted 4-8 hours. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Jaw Pain Patients | Individuals seeking care for jaw pain, including temporomandibular joint and muscle disorder (TMD). Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pressure Pain Threshold | Pressure at which stimulation at the masseter insertion becomes painful, in lbf. Positive values represent higher pain thresholds. | Posted | Mean | Standard Deviation | lbf | Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.) |
|
Duration of study participation (4-8 hours per study session, with at least 48 hours separating each session)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Jaw Pain Patients: Ethanol | Individuals seeking care for jaw pain, including temporomandibular joint and muscle disorder (TMD). Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea and vomiting | Gastrointestinal disorders | Non-systematic Assessment | Approximately 2.5 hours after consuming the study beverage, while metabolizing alcohol dose prior to transport home, participant reported feeling nauseous and vomited. Participant's BrAC was 0.04. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeff Boissoneault, PhD | University of Florida | 352-273-6147 | jboissoneault@phhp.ufl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 2, 2021 | Feb 27, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 17, 2021 | Feb 27, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D013705 | Temporomandibular Joint Disorders |
| ID | Term |
|---|---|
| D017271 | Craniomandibular Disorders |
| D008336 | Mandibular Diseases |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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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.
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| Placebo | Other | A beverage that does not meaningfully increase breath alcohol concentration. |
|
| BG001 |
| Healthy Controls |
Healthy social drinkers without jaw pain recruited as a comparison group. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Alcohol Use Disorders Identification Test (total score) | The Alcohol Use Disorders Identification Test (AUDIT) is a standardized assessment of drinking frequency and heaviness, as well as consequences associated with alcohol intake. Higher scores reflect heavier/more frequent drinking and more severe alcohol-related consequences. Items are summed to compute total score, which can range from 0-40. | Mean | Standard Deviation | units on a scale |
|
| Quantity-Frequency Index | Mean | Standard Deviation | oz. absolute ethanol consumed per day |
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| Max Quantity (oz. abs. EtOH) | Mean | Standard Deviation | oz. absolute ethanol |
|
| Oral Health Impact Profile - TMDs (total score) | The Oral Health Impact Profile - TMDs is a temporomandibular joint and muscle disorder (TMD) specific version of the Oral Health Impact Profile. Total scores are generated by summing each item and range from 0-88. Higher scores indicate more severe TMD-related symptoms and quality of life impacts. | Mean | Standard Deviation | units on a scale |
|
| OG002 | Jaw Pain Patients: Placebo | Individuals seeking care for jaw pain, including temporomandibular joint and muscle disorder (TMD). Placebo: A beverage that does not meaningfully increase breath alcohol concentration. |
| OG003 | Healthy Controls: Placebo | Healthy social drinkers without jaw pain recruited as a comparison group. Placebo: A beverage that does not meaningfully increase breath alcohol concentration. |
|
|
|
| Primary | 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. | Participant ratings from stimuli that were not within 0.5 lbf of the target pressure were excluded from analyses. This resulted in exclusion of 3 participants' data from this analysis. | Posted | Mean | Standard Deviation | VAS units | Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.) |
|
|
|
|
| Primary | 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. | One participant had missing data on this measure, resulting from exclusion from analyses. | Posted | Mean | Standard Deviation | VAS units | Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.) |
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|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | Healthy Controls: Ethanol | Healthy social drinkers without jaw pain recruited as a comparison group. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration. | 0 | 29 | 0 | 29 | 1 | 29 |
| EG002 | Jaw Pain Patients: Placebo | Individuals seeking care for jaw pain, including temporomandibular joint and muscle disorder (TMD). Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration. | 0 | 19 | 0 | 19 | 0 | 19 |
| EG003 | Healthy Controls: Placebo | Healthy social drinkers without jaw pain recruited as a comparison group. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration. | 0 | 29 | 0 | 29 | 0 | 29 |
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| D007592 |
| Joint Diseases |
| D009135 | Muscular Diseases |
| D009057 | Stomatognathic Diseases |
| 2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain intensity. Here we report the results of the analysis of the pressure level X beverage condition interaction. | ANCOVA | F(2,82)=.66 | .52 | Superiority |
| 2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain intensity. Here we report the results of the analysis of the main effect of beverage condition. | ANOVA | F(1,41)=4.53, p=.04 | .04 | Superiority |
| 2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain intensity. Here we report the results of the analysis of the main effect of group. | ANOVA | F(1,41)=6.24 | .017 | Superiority |
| 2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain intensity. Here we report the results of the analysis of the main effect of pressure level. | ANOVA | F(2,82)=48.41 | <.0001 | Superiority |
| 2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain relief. Here we report the results of the analysis of the beverage condition X pressure level interaction. | ANOVA | F(2,82)=1.58 | .21 | Superiority |
| 2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain relief. Here we report the results of the analysis of the pressure level X group interaction. | ANOVA | F(2,82)=3.06 | .053 | Superiority |
| 2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain relief. Here we report the results of the analysis of the beverage condition X group interaction. | ANOVA | F(1,41)=.001 | .98 | Superiority |
| 2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain relief. Here we report the results of the analysis of the main effect of pressure level. | ANOVA | F(2,82)=.34 | .71 | Superiority |
| 2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain relief. Here we report the results of the analysis of the main effect of group. | ANOVA | F(1,41)=.14 | .71 | Superiority |
| 2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain relief. Here we report the results of the analysis of the main effect of beverage condition. | ANOVA | F(1,41)=55.02 | <.0001 | Superiority |