Back to resultsAcute Effects of Alcohol Use on Chronic Orofacial Pain
Primary Purpose
Temporomandibular Joint Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ethanol
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Temporomandibular Joint Disorders focused on measuring alcohol effects
Eligibility Criteria
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
Sites / Locations
- Center for Pain Research and Behavioral Health at UF Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Jaw pain patients
Healthy controls
Arm Description
Individuals seeking care for jaw pain, including temporomandibular joint and muscle disorder (TMD).
Healthy social drinkers without jaw pain recruited as a comparison group.
Outcomes
Primary Outcome Measures
Pressure Pain Threshold
Pressure at which stimulation at the masseter insertion becomes painful, in lbf. Positive values represent higher pain thresholds.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04019093
First Posted
July 11, 2019
Last Updated
July 5, 2023
Sponsor
University of Florida
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT04019093
Brief Title
Acute Effects of Alcohol Use on Chronic Orofacial Pain
Official Title
Acute Effects of Alcohol Use on Chronic Orofacial Pain
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
November 5, 2019 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
April 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Joint Disorders
Keywords
alcohol effects
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
ParticipantInvestigator
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Jaw pain patients
Arm Type
Experimental
Arm Description
Individuals seeking care for jaw pain, including temporomandibular joint and muscle disorder (TMD).
Arm Title
Healthy controls
Arm Type
Experimental
Arm Description
Healthy social drinkers without jaw pain recruited as a comparison group.
Intervention Type
Drug
Intervention Name(s)
Ethanol
Intervention Description
A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
A beverage that does not meaningfully increase breath alcohol concentration.
Primary Outcome Measure Information:
Title
Pressure Pain Threshold
Description
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.)
Title
Pressure Pain Intensity
Description
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.)
Title
Perceived Relief
Description
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.)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeff Boissoneault, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Pain Research and Behavioral Health at UF Health
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Acute Effects of Alcohol Use on Chronic Orofacial Pain
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