Characterizing the Effects of Family History of Alcoholism on Alcohol Analgesia

NCT04925076 | Completed Results

• 2 other identifiers: IRB201800992-NR01AA025337
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Effects of Family History of Alcoholism and Sex on Alcohol Analgesia

Keywords

alcohol effects; pain

Outcome Measures

Primary Outcomes (15)

• 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.)

• 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.)

• Heat Pain Intensity 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 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.

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

• Perceived Pain Relief

  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.

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

• Dorsolateral Prefrontal Cortex Activation

  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.

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

• Hypothalamus Activation

  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.

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

• Medial Prefrontal Cortex Activation

  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.

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

• Nucleus Accumbens Activation

  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.

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

• Periaqueductal Gray Activation

  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.

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

• Anterior Cingulate Cortex Activation

  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.

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

• Amgydala Activation

  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.

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

• Hippocampus Activation

  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.

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

• Insula Activation

  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.

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

• Postcentral Gyrus Activation

  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.

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

• Thalamus Activation

  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.

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

Study Arms (2)

Family History Positive

EXPERIMENTAL

People reporting at least one parent with a history of alcohol problems.

Drug: Ethanol; Other: Placebo

Family History Negative

EXPERIMENTAL

People who do not report having a parent with a history of alcohol problems.

Drug: Ethanol; Other: Placebo

Interventions

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.

Family History Negative; Family History Positive

Placebo OTHER

A beverage that does not meaningfully increase breath alcohol concentration.

Family History Negative; Family History Positive

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- Consume at least 1 drink/month over the past 6 months

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Florida: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Center for Pain Research and Behavioral Health at UF Health

Gainesville, Florida, 32610, United States

Location

Related Publications (2)

• Boissoneault J, Stennett B, Robinson ME. Acute alcohol intake alters resting state functional connectivity of nucleus accumbens with pain-related corticolimbic structures. Drug Alcohol Depend. 2020 Feb 1;207:107811. doi: 10.1016/j.drugalcdep.2019.107811. Epub 2019 Dec 24.

  PMID: 31891860 RESULT

• Sevel L, Stennett B, Schneider V 2nd, Bush N, Nixon SJ, Robinson M, Boissoneault J. Acute Alcohol Intake Produces Widespread Decreases in Cortical Resting Signal Variability in Healthy Social Drinkers. Alcohol Clin Exp Res. 2020 Jul;44(7):1410-1419. doi: 10.1111/acer.14381. Epub 2020 Jun 18.

  PMID: 32472620 RESULT

MeSH Terms

Conditions

Pain

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Results Point of Contact

• Title: Jeff Boissoneault, PhD
• Organization: University of Minnesota

jboisson@umn.edu

612-624-7357

Study Officials

• Jeff Boissoneault, PhD

  Assistant Professor

  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
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will receive an active oral dose of alcohol or placebo in a counterbalanced manner.

Study Record Dates

• First Submitted: June 8, 2021
• First Posted: June 14, 2021
• Study Start: November 20, 2018
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: August 13, 2024
• Results First Posted: August 13, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)