NCT04019093

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 15, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

November 5, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

July 27, 2023

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

2.5 years

First QC Date

July 11, 2019

Results QC Date

February 27, 2023

Last Update Submit

July 5, 2023

Conditions

Temporomandibular Joint Disorders

Keywords

alcohol effects

Outcome Measures

Primary Outcomes (3)

  • 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.)

Study Arms (2)

Jaw pain patients

EXPERIMENTAL

Individuals seeking care for jaw pain, including temporomandibular joint and muscle disorder (TMD).

Drug: EthanolOther: Placebo

Healthy controls

EXPERIMENTAL

Healthy social drinkers without jaw pain recruited as a comparison group.

Drug: EthanolOther: Placebo

Interventions

EthanolDRUG

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

Healthy controlsJaw pain patients
PlaceboOTHER

A beverage that does not meaningfully increase breath alcohol concentration.

Healthy controlsJaw pain patients

Eligibility Criteria

Age21 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Pain Research and Behavioral Health at UF Health

Gainesville, Florida, 32610, United States

Location

Related Publications (1)

  • 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.

    PMID: 37358545DERIVED

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Results Point of Contact

Title
Jeff Boissoneault, PhD
Organization
University of Florida
jboissoneault@phhp.ufl.edu
352-273-6147

Study Officials

  • Jeff Boissoneault, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2019

First Posted

July 15, 2019

Study Start

November 5, 2019

Primary Completion

April 30, 2022

Study Completion

April 30, 2022

Last Updated

July 27, 2023

Results First Posted

July 27, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)