Acute Effects of Alcohol Use on Chronic Orofacial Pain

Temporomandibular Joint Disorders Clinical Trial

Official title:

Acute Effects of Alcohol Use on Chronic Orofacial Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04019093
• Other study ID #: IRB201801911-N
• Secondary ID: R21AA026805
• Status: Completed
• Phase: N/A
• Start date: November 5, 2019
• Est. completion date: April 30, 2022

Study information

• Verified date: July 2023
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Facial Pain
• Joint Diseases
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Drug:
• Ethanol
A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.

Other:
• Placebo
A beverage that does not meaningfully increase breath alcohol concentration.

Locations

Country	Name	City	State
United States	Center for Pain Research and Behavioral Health at UF Health	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.)
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.	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.	Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.)