Temporomandibular Joint DisordersNCT04019093

Acute Effects of Alcohol Use on Chronic Orofacial Pain

A study testing Ethanol in people with Temporomandibular Joint Disorders, run by University of Florida at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 21 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Temporomandibular Joint Disorders
What is being tested?: Ethanol
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 48 participants
Where: 1 siteUnited States
Study dates: 5 Nov 2019to 30 Apr 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Center for Pain Research and Behavioral Health at UF Health
Gainesville, Florida, 32610

Other trials in United States

About this study

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.

Conditions: Temporomandibular Joint Disorders
Being tested: Ethanol, Placebo
Keywords: alcohol effects
Medical subject headings: Temporomandibular Joint Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EthanolDrug
A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.
PlaceboOther
A beverage that does not meaningfully increase breath alcohol concentration.

Study groups in NCT04019093
Study group	Role	What they receive
Jaw pain patients	Experimental	Individuals seeking care for jaw pain, including temporomandibular joint and muscle disorder (TMD). Receives: Drug: Ethanol; Other: Placebo
Healthy controls	Experimental	Healthy social drinkers without jaw pain recruited as a comparison group. Receives: Drug: Ethanol; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Pressure Pain Threshold
Pressure at which stimulation at the masseter insertion becomes painful, in lbf. Positive values represent higher pain thresholds.
Measured: 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.
Measured: 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.
Measured: Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Nov 201930 Apr 2022

First posted15 Jul 2019
Study start5 Nov 2019
Primary completion30 Apr 2022
Study completion30 Apr 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Temporomandibular Joint DisordersStudies of the same condition, open and under way.
More trials run by University of FloridaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
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: Double blind
Who is masked: Participant, Investigator
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04019093
Sponsor's protocol ID: IRB201801911-N
Other IDs: R21AA026805
Status last verified: Jul 2023
First submitted: 11 Jul 2019
Last updated: 27 Jul 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 37358545

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Photobiomodulation for Management of Temporomandibular Disorder Pain
Pain Related to TMD
Recruiting
Effects of Vagus Nerve Stimulation on Temporomandibular Disorders.
TMD, Temporomandibular Disorders (TMDs)
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Not yet recruiting
Comparing Dextrose Prolotherapy vs. Sodium Hyaluronic Acid Injections for Jaw Joint Internal Derangement
Temporomandibular Joint Internal Derangement, TMJ-ID
Recruiting
R01_Pilot Jaw Muscle Phenotypes
Chronic TMD Pain, Temporomandibular Disorder

All Temporomandibular Joint Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Acute Effects of Alcohol Use on Chronic Orofacial Pain
ClinicalTrials.gov ID: NCT04019093
Acronym / sponsor ID: IRB201801911-N
Conditions: Temporomandibular Joint Disorders
Keywords: alcohol effects
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: University of FloridaUniversity, hospital or other
Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study start: 5 Nov 2019 (actual)
Primary completion: 30 Apr 2022 (actual)
Study completion: 30 Apr 2022 (actual)
First posted: 15 Jul 2019 (actual)
Results: Posted 27 Jul 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2
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.

Arm	Type	Receives
Jaw pain patients	Experimental	Drug: Ethanol, Other: PlaceboIndividuals seeking care for jaw pain, including temporomandibular joint and muscle disorder (TMD).
Healthy controls	Experimental	Drug: Ethanol, Other: PlaceboHealthy social drinkers without jaw pain recruited as a comparison group.

Who may qualify

Ages: 21 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EthanolA beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.	Drug	Healthy controls, Jaw pain patients
PlaceboA beverage that does not meaningfully increase breath alcohol concentration.	Other	Healthy controls, Jaw pain patients

Primary outcome

Pressure Pain Threshold
Time frame: Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.)
Pressure at which stimulation at the masseter insertion becomes painful, in lbf. Positive values represent higher pain thresholds.
Pressure Pain Intensity
Time frame: Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.)
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
Time frame: Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.)
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.

Results and safety

Results posted to the registry on 27 Jul 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Jaw Pain Patients: Ethanol First, Then Placebo	9	9
Healthy Controls: Ethanol First, Then Placebo	16	16
Jaw Pain Patients: Placebo First, Then Ethanol	10	10
Healthy Controls: Placebo First, Then Ethanol	13	13

Primary outcome: Pressure Pain Threshold

Time frame: Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.). Mean (Standard Deviation). Unit: lbf

Measure	Jaw Pain Patients: Ethanol n = 19	Healthy Controls: Ethanol n = 29	Jaw Pain Patients: Placebo n = 19	Healthy Controls: Placebo n = 29
Value	4.56 (1.08)	5.27 (1.37)	3.81 (0.84)	4.51 (1.21)

Jaw Pain Patients: Ethanol vs Healthy Controls: Ethanol vs Jaw Pain Patients: Placebo vs Healthy Controls: Placebo: p = .99, ANOVA
Jaw Pain Patients: Ethanol vs Healthy Controls: Ethanol vs Jaw Pain Patients: Placebo vs Healthy Controls: Placebo: p <.0001, ANOVA
Jaw Pain Patients: Ethanol vs Healthy Controls: Ethanol vs Jaw Pain Patients: Placebo vs Healthy Controls: Placebo: p = .015, ANOVA

Primary outcome: Pressure Pain Intensity

Time frame: Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.). Mean (Standard Deviation). Unit: VAS units

Measure	Jaw Pain Patients: Ethanol, 4lbf n = 17	Healthy Controls: Ethanol, 4lbf n = 28	Jaw Pain Patients: Placebo, 4lbf n = 17	Healthy Controls: Placebo, 4lbf n = 28	Jaw Pain Patients: Ethanol, 5lbf n = 17	Healthy Controls: Ethanol, 5lbf n = 28	Jaw Pain Patients: Placebo, 5lbf n = 17	Healthy Controls: Placebo, 5lbf n = 28	Jaw Pain Patients: Ethanol, 6lbf n = 17	Healthy Controls: Ethanol, 6lbf n = 28	Jaw Pain Patients: Placebo, 6lbf n = 17	Healthy Controls: Placebo, 6lbf n = 28
Value	23.96 (28.03)	12.76 (13.44)	32.39 (19.95)	22.05 (17.72)	35.43 (19.67)	20.92 (17.02)	41.81 (20.28)	29.98 (23.89)	37.19 (23.90)	26.95 (23.06)	46.10 (22.97)	34.03 (22.94)

Jaw Pain Patients: Ethanol, 4lbf vs Healthy Controls: Ethanol, 4lbf vs Jaw Pain Patients: Placebo, 4lbf vs Healthy Controls: Placebo, 4lbf vs Jaw Pain Patients: Ethanol, 5lbf vs Healthy Controls: Ethanol, 5lbf vs Jaw Pain Patients: Placebo, 5lbf vs Healthy Controls: Placebo, 5lbf vs Jaw Pain Patients: Ethanol, 6lbf vs Healthy Controls: Ethanol, 6lbf vs Jaw Pain Patients: Placebo, 6lbf vs Healthy Controls: Placebo, 6lbf: p = .76, ANOVA
Jaw Pain Patients: Ethanol, 4lbf vs Healthy Controls: Ethanol, 4lbf vs Jaw Pain Patients: Placebo, 4lbf vs Healthy Controls: Placebo, 4lbf vs Jaw Pain Patients: Ethanol, 5lbf vs Healthy Controls: Ethanol, 5lbf vs Jaw Pain Patients: Placebo, 5lbf vs Healthy Controls: Placebo, 5lbf vs Jaw Pain Patients: Ethanol, 6lbf vs Healthy Controls: Ethanol, 6lbf vs Jaw Pain Patients: Placebo, 6lbf vs Healthy Controls: Placebo, 6lbf: p = .52, ANCOVA
Jaw Pain Patients: Ethanol, 4lbf vs Healthy Controls: Ethanol, 4lbf vs Jaw Pain Patients: Placebo, 4lbf vs Healthy Controls: Placebo, 4lbf vs Jaw Pain Patients: Ethanol, 5lbf vs Healthy Controls: Ethanol, 5lbf vs Jaw Pain Patients: Placebo, 5lbf vs Healthy Controls: Placebo, 5lbf vs Jaw Pain Patients: Ethanol, 6lbf vs Healthy Controls: Ethanol, 6lbf vs Jaw Pain Patients: Placebo, 6lbf vs Healthy Controls: Placebo, 6lbf: p = .04, ANOVA

Population analysed: Participant ratings from stimuli that were not within 0.5 lbf of the target pressure were excluded from analyses. This resulted in exclusion of 3 participants' data from this analysis.

Primary outcome: Perceived Relief

Time frame: Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.). Mean (Standard Deviation). Unit: VAS units

Measure	Jaw Pain Patients: Ethanol, 4lbf n = 19	Healthy Controls: Ethanol, 4lbf n = 28	Jaw Pain Patients: Placebo, 4lbf n = 19	Healthy Controls: Placebo, 4lbf n = 28	Jaw Pain Patients: Ethanol, 5lbf n = 19	Healthy Controls: Ethanol, 5lbf n = 28	Jaw Pain Patients: Placebo, 5lbf n = 19	Healthy Controls: Placebo, 5lbf n = 28	Jaw Pain Patients: Ethanol, 6lbf n = 19	Healthy Controls: Ethanol, 6lbf n = 28	Jaw Pain Patients: Placebo, 6lbf n = 19	Healthy Controls: Placebo, 6lbf n = 28
Value	40.58 (31.31)	39.79 (30.58)	7.91 (13.71)	5.51 (11.36)	41.00 (28.27)	42.75 (30.14)	7.20 (13.01)	5.57 (11.13)	39.72 (30.05)	43.65 (29.61)	7.20 (13.41)	5.89 (13.11)

Jaw Pain Patients: Ethanol, 4lbf vs Healthy Controls: Ethanol, 4lbf vs Jaw Pain Patients: Placebo, 4lbf vs Healthy Controls: Placebo, 4lbf vs Jaw Pain Patients: Ethanol, 5lbf vs Healthy Controls: Ethanol, 5lbf vs Jaw Pain Patients: Placebo, 5lbf vs Healthy Controls: Placebo, 5lbf vs Jaw Pain Patients: Ethanol, 6lbf vs Healthy Controls: Ethanol, 6lbf vs Jaw Pain Patients: Placebo, 6lbf vs Healthy Controls: Placebo, 6lbf: p = .50, ANOVA
Jaw Pain Patients: Ethanol, 4lbf vs Healthy Controls: Ethanol, 4lbf vs Jaw Pain Patients: Placebo, 4lbf vs Healthy Controls: Placebo, 4lbf vs Jaw Pain Patients: Ethanol, 5lbf vs Healthy Controls: Ethanol, 5lbf vs Jaw Pain Patients: Placebo, 5lbf vs Healthy Controls: Placebo, 5lbf vs Jaw Pain Patients: Ethanol, 6lbf vs Healthy Controls: Ethanol, 6lbf vs Jaw Pain Patients: Placebo, 6lbf vs Healthy Controls: Placebo, 6lbf: p = .21, ANOVA
Jaw Pain Patients: Ethanol, 4lbf vs Healthy Controls: Ethanol, 4lbf vs Jaw Pain Patients: Placebo, 4lbf vs Healthy Controls: Placebo, 4lbf vs Jaw Pain Patients: Ethanol, 5lbf vs Healthy Controls: Ethanol, 5lbf vs Jaw Pain Patients: Placebo, 5lbf vs Healthy Controls: Placebo, 5lbf vs Jaw Pain Patients: Ethanol, 6lbf vs Healthy Controls: Ethanol, 6lbf vs Jaw Pain Patients: Placebo, 6lbf vs Healthy Controls: Placebo, 6lbf: p = .053, ANOVA

Adverse events

Time frame: Duration of study participation (4-8 hours per study session, with at least 48 hours separating each session). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Jaw Pain Patients: Ethanol	0 of 19 (0%)	0 of 19 (0%)	0 of 19
Healthy Controls: Ethanol	0 of 29 (0%)	1 of 29 (3.4%)	0 of 29
Jaw Pain Patients: Placebo	0 of 19 (0%)	0 of 19 (0%)	0 of 19
Healthy Controls: Placebo	0 of 29 (0%)	0 of 29 (0%)	0 of 29

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37358545Alexander 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.
Individual participant dataSharing planned: No

Related trials for Temporomandibular Joint Disorders

Recruiting
Photobiomodulation for Management of Temporomandibular Disorder Pain
Pain Related to TMD
Recruiting
Effects of Vagus Nerve Stimulation on Temporomandibular Disorders.
TMD, Temporomandibular Disorders (TMDs)
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Not yet recruiting
Comparing Dextrose Prolotherapy vs. Sodium Hyaluronic Acid Injections for Jaw Joint Internal Derangement
Temporomandibular Joint Internal Derangement, TMJ-ID
Recruiting
R01_Pilot Jaw Muscle Phenotypes
Chronic TMD Pain, Temporomandibular Disorder

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jeff Boissoneault, PhD principal investigator

University of Florida

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Ethanol in people with Temporomandibular Joint Disorders, run by University of Florida at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pressure Pain Threshold (time frame: Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04019093, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.