Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Acute Effects of Alcohol Use on Chronic Orofacial Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04019093
Recruitment Status : Recruiting
First Posted : July 15, 2019
Last Update Posted : May 29, 2020
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
University of Florida

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.

Condition or disease Intervention/treatment Phase
Temporomandibular Joint Disorders Drug: Ethanol Other: Placebo Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: People with and without temporomandibular joint and muscle disorder (TMD) will receive an active oral dose of alcohol or placebo in a counterbalanced manner.
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Acute Effects of Alcohol Use on Chronic Orofacial Pain
Actual Study Start Date : November 5, 2019
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arm Intervention/treatment
Experimental: TMD patients
Individuals seeking care for temporomandibular joint and muscle disorder (TMD).
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.

Experimental: Healthy controls
Healthy social drinkers without TMD recruited as a comparison group.
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.




Primary Outcome Measures :
  1. Change in Pressure Pain Threshold [ Time Frame: Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.) ]
    Pressure applied at insertion of the masseter at which participant reports pain. VAS (visual analogue scale) pain intensity and unpleasantness ratings anchored from "no pain at all"/"not at all unpleasant" to "most intense/unpleasant imaginable" will be collected.

  2. Change in Pressure Pain Intensity - 4 fpsi [ Time Frame: Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.) ]
    Pain ratings associated with 6 foot pounds per square inch (fpsi) of pressure applied to the insertion of the masseter. VAS (visual analogue scale) pain intensity and unpleasantness ratings anchored from "no pain at all"/"not at all unpleasant" to "most intense/unpleasant imaginable" will be collected.

  3. Change in Pressure Pain Intensity - 5 fpsi [ Time Frame: Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.) ]
    Pain ratings associated with 7 foot pounds per square inch (fpsi) of pressure applied to the insertion of the masseter. VAS (visual analogue scale) pain intensity and unpleasantness ratings anchored from "no pain at all"/"not at all unpleasant" to "most intense/unpleasant imaginable" will be collected.

  4. Change in Pressure Pain Intensity - 6 fpsi [ Time Frame: Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.) ]
    Pain ratings associated with 8 foot pounds per square inch (fpsi) of pressure applied to the insertion of the masseter. VAS (visual analogue scale) pain intensity and unpleasantness ratings anchored from "no pain at all"/"not at all unpleasant" to "most intense/unpleasant imaginable" will be collected.

  5. Change in Perceived Relief [ Time Frame: Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.) ]
    Rating of relief from pain associated with consumption of the study beverage. VAS (visual analogue scale) assessing perceived relief anchored from "No relief at all" to "Most profound relief imaginable".



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   23 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04019093


Contacts
Layout table for location contacts
Contact: Jeff Boissoneault, PhD 352-273-6147 jboissoneault@phhp.ufl.edu
Contact: Michael Robinson, PhD 352-273-6153 merobin@phhp.ufl.edu

Locations
Layout table for location information
United States, Florida
Center for Pain Research and Behavioral Health at UF Health Recruiting
Gainesville, Florida, United States, 32610
Principal Investigator: Jeff Boissoneault, PhD         
Sponsors and Collaborators
University of Florida
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
Layout table for investigator information
Principal Investigator: Jeff Boissoneault, PhD University of Florida
Layout table for additonal information
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT04019093    
Other Study ID Numbers: IRB201801911-N
R21AA026805 ( U.S. NIH Grant/Contract )
First Posted: July 15, 2019    Key Record Dates
Last Update Posted: May 29, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Florida:
alcohol effects
Additional relevant MeSH terms:
Layout table for MeSH terms
Joint Diseases
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Facial Pain
Musculoskeletal Diseases
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes
Pain
Neurologic Manifestations
Signs and Symptoms
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs