Characterizing the Effects of Family History of Alcoholism on Alcohol Analgesia

Study Overview
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Brief Summary
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Self-medication of pain with alcohol is a common, yet risky, behavior. Evidence suggests family history of alcoholism may affect the degree to which alcohol use relieves pain, but the independent contributions of expectation and conditioning have not been previously studied. Interactive effects of sex and family history are also currently unclear. This project addresses this gap in knowledge and will inform further research and clinical/translational efforts for reducing risk associated with these behaviors.

Official Title
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Characterizing the Effects of Family History of Alcoholism on Alcohol Analgesia

Conditions
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Effects of Family History of Alcoholism and Sex on Alcohol Analgesia

Intervention / Treatment
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* Drug: Ethanol
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Consume at least 1 drink/month over the past 6 months Exclusion Criteria: History of chronic pain 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 Safety concerns related to MRI (for example, implants or pacing devices)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Participants will receive an active oral dose of alcohol or placebo in a counterbalanced manner.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Family History Positive<br>People reporting at least one parent with a history of alcohol problems. | Drug: Ethanol<br>* A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.<br>Other: Placebo<br>* A beverage that does not meaningfully increase breath alcohol concentration.<br>|
| Experimental: Family History Negative<br>People who do not report having a parent with a history of alcohol problems. | Drug: Ethanol<br>* A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.<br>Other: Placebo<br>* A beverage that does not meaningfully increase breath alcohol concentration.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Heat Pain Threshold | Temperature of heat stimulus applied to the foot 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. | Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.) | 
| Change in Heat Pain Tolerance | Temperature of heat stimulus applied to the foot at which participant no longer tolerates 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. | Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.) | 
| Change in Heat Pain Ratings | Participant perception of pain at a temperature producing a pain rating of approximately 5 out of 10 at baseline. VAS (visual analogue scale) pain intensity ratings anchored from no pain at all to most intense imaginable will be collected. | Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.) | 
| Change in Perceived Relief | 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. | Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.) | 
| Change in Activity of Pain-related Brain Regions during Painful Stimulation | Functional activation of brain regions involved in pain response | Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.) | 
| Change in Connectivity of Pain-related Brain Regions during Painful Stimulation | Functional connectivity of brain regions involved in pain response | Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, alcohol effects