Acute Effects of Alcohol Use on Chronic Orofacial Pain

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-05

Study Completion Date

2022-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Temporomandibular Joint Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Jaw pain patients

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

Group Type EXPERIMENTAL

Ethanol

Intervention Type DRUG

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

Placebo

Intervention Type OTHER

A beverage that does not meaningfully increase breath alcohol concentration.

Healthy controls

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

Group Type EXPERIMENTAL

Ethanol

Intervention Type DRUG

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

Placebo

Intervention Type OTHER

A beverage that does not meaningfully increase breath alcohol concentration.

Interventions

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Ethanol

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

Intervention Type DRUG

Placebo

A beverage that does not meaningfully increase breath alcohol concentration.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes