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Completed

NCT Number: NCT04925076

Characterizing the Effects of Family History of Alcoholism on Alcohol Analgesia

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.

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Key information

Conditions

Effects of Family History of Alcoholism and Sex on Alcohol Analgesia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

21 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Pain Research and Behavioral Health at UF Health

Gainesville, Florida, 32610, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Ethanol

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

Other

A beverage that does not meaningfully increase breath alcohol concentration.

Primary outcomes

  1. Heat Pain Threshold

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

    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.

  2. Heat Pain Tolerance

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

    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.

  3. Heat Pain Intensity Ratings

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

    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 ranging from 0-100 and anchored from "no pain at all" to "most intense imaginable" will be collected. Higher values reflect ratings of more intense pain.

  4. Perceived Pain 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. This is a VAS (visual analogue scale) assessing perceived pain relief ranging from 0-100 and anchored from "No relief at all" to "Most profound relief imaginable". Higher scores reflect greater perception of pain relief.

  5. Dorsolateral Prefrontal Cortex Activation

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

    Pain-related activation in the dorsolateral prefrontal cortex associated with application of painful heat vs. non-noxious warmth to the bottom of the right foot during fMRI acquisition. Scores are beta-weights associated with fit of activity within the region to activity predicted by convolving the canonical hemodynamic response function with the heat pain stimulus paradigm assessed using general linear modeling. Positive beta weights reflect activation associated with the stimulus paradigm, while negative beta weights reflect deactivation.

  6. Hypothalamus Activation

    Time frame: Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours

    Pain-related activation in the hypothalamus associated with application of painful heat vs. non-noxious warmth to the bottom of the right foot during fMRI acquisition. Scores are beta-weights associated with fit of activity within the region to activity predicted by convolving the canonical hemodynamic response function with the heat pain stimulus paradigm assessed using general linear modeling. Positive beta weights reflect activation associated with the stimulus paradigm, while negative beta weights reflect deactivation.

  7. Medial Prefrontal Cortex Activation

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

    Pain-related activation in the medial prefrontal cortex associated with application of painful heat vs. non-noxious warmth to the bottom of the right foot during fMRI acquisition. Scores are beta-weights associated with fit of activity within the region to activity predicted by convolving the canonical hemodynamic response function with the heat pain stimulus paradigm assessed using general linear modeling. Positive beta weights reflect activation associated with the stimulus paradigm, while negative beta weights reflect deactivation.

  8. Nucleus Accumbens Activation

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

    Pain-related activation in the nucleus accumbens associated with application of painful heat vs. non-noxious warmth to the bottom of the right foot during fMRI acquisition. Scores are beta-weights associated with fit of activity within the region to activity predicted by convolving the canonical hemodynamic response function with the heat pain stimulus paradigm assessed using general linear modeling. Positive beta weights reflect activation associated with the stimulus paradigm, while negative beta weights reflect deactivation.

  9. Periaqueductal Gray Activation

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

    Pain-related activation in the periaqueductal gray associated with application of painful heat vs. non-noxious warmth to the bottom of the right foot during fMRI acquisition. Scores are beta-weights associated with fit of activity within the region to activity predicted by convolving the canonical hemodynamic response function with the heat pain stimulus paradigm assessed using general linear modeling. Positive beta weights reflect activation associated with the stimulus paradigm, while negative beta weights reflect deactivation.

  10. Anterior Cingulate Cortex Activation

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

    Pain-related activation in the anterior cingulate cortex associated with application of painful heat vs. non-noxious warmth to the bottom of the right foot during fMRI acquisition. Scores are beta-weights associated with fit of activity within the region to activity predicted by convolving the canonical hemodynamic response function with the heat pain stimulus paradigm assessed using general linear modeling. Positive beta weights reflect activation associated with the stimulus paradigm, while negative beta weights reflect deactivation.

  11. Amgydala Activation

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

    Pain-related activation in the amygdala associated with application of painful heat vs. non-noxious warmth to the bottom of the right foot during fMRI acquisition. Scores are beta-weights associated with fit of activity within the region to activity predicted by convolving the canonical hemodynamic response function with the heat pain stimulus paradigm assessed using general linear modeling. Positive beta weights reflect activation associated with the stimulus paradigm, while negative beta weights reflect deactivation.

  12. Hippocampus Activation

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

    Pain-related activation in the hippocampus associated with application of painful heat vs. non-noxious warmth to the bottom of the right foot during fMRI acquisition. Scores are beta-weights associated with fit of activity within the region to activity predicted by convolving the canonical hemodynamic response function with the heat pain stimulus paradigm assessed using general linear modeling. Positive beta weights reflect activation associated with the stimulus paradigm, while negative beta weights reflect deactivation.

  13. Insula Activation

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

    Pain-related activation in the insula associated with application of painful heat vs. non-noxious warmth to the bottom of the right foot during fMRI acquisition. Scores are beta-weights associated with fit of activity within the region to activity predicted by convolving the canonical hemodynamic response function with the heat pain stimulus paradigm assessed using general linear modeling. Positive beta weights reflect activation associated with the stimulus paradigm, while negative beta weights reflect deactivation.

  14. Postcentral Gyrus Activation

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

    Pain-related activation in the postcentral gyrus associated with application of painful heat vs. non-noxious warmth to the bottom of the right foot during fMRI acquisition. Scores are beta-weights associated with fit of activity within the region to activity predicted by convolving the canonical hemodynamic response function with the heat pain stimulus paradigm assessed using general linear modeling. Positive beta weights reflect activation associated with the stimulus paradigm, while negative beta weights reflect deactivation.

  15. Thalamus Activation

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

    Pain-related activation in the thalamus associated with application of painful heat vs. non-noxious warmth to the bottom of the right foot during fMRI acquisition. Scores are beta-weights associated with fit of activity within the region to activity predicted by convolving the canonical hemodynamic response function with the heat pain stimulus paradigm assessed using general linear modeling. Positive beta weights reflect activation associated with the stimulus paradigm, while negative beta weights reflect deactivation.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Jun 14, 2021
Registry last updated
Aug 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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