Acute Effects of Alcohol Use on Chronic Orofacial Pain

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 23 Years - 45 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Positive diagnosis of temporomandibular joint and muscle disorder (TMD) (TMD group only) - Consume at least 1 drink/month over the past 6 months

Exclusion Criteria:

- History of chronic pain other than 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04019093
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Florida
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Jeff Boissoneault, PhD
Principal Investigator Affiliation University of Florida
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherNIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Temporomandibular Joint Disorders
Arms & Interventions

Arms

Experimental: TMD patients

Individuals seeking care for temporomandibular joint and muscle disorder (TMD).

Experimental: Healthy controls

Healthy social drinkers without TMD recruited as a comparison group.

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Gainesville, Florida

Status

Recruiting

Address

Center for Pain Research and Behavioral Health at UF Health

Gainesville, Florida, 32610