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Characterizing the Effects of Family History of Alcoholism on Alcohol Analgesia

Sponsor
University of Florida (Other)
Overall Status
Recruiting
CT.gov ID
NCT04925076
Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)
110
Enrollment
1
Location
2
Arms
54.3
Anticipated Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
110 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Participants will receive an active oral dose of alcohol or placebo in a counterbalanced manner.Participants will receive an active oral dose of alcohol or placebo in a counterbalanced manner.
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
Characterizing the Effects of Family History of Alcoholism on Alcohol Analgesia
Actual Study Start Date :
Nov 20, 2018
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Family History Positive

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

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

Other: Placebo
A beverage that does not meaningfully increase breath alcohol concentration.
Experimental: Family History Negative

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

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

Other: Placebo
A beverage that does not meaningfully increase breath alcohol concentration.

Outcome Measures

Primary Outcome Measures

  1. Change in Heat Pain Threshold [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. Change in Heat Pain Tolerance [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. Change in Heat Pain Ratings [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 anchored from "no pain at all" to "most intense imaginable" will be collected.

  4. Change in Perceived Relief [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. VAS (visual analogue scale) assessing perceived relief anchored from "No relief at all" to "Most profound relief imaginable".

  5. Change in Activity of Pain-related Brain Regions during Painful Stimulation [Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.)]

    Functional activation of brain regions involved in pain response

  6. Change in Connectivity of Pain-related Brain Regions during Painful Stimulation [Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.)]

    Functional connectivity of brain regions involved in pain response

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Center for Pain Research and Behavioral Health at UF Health Gainesville Florida United States 32610

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Jeff Boissoneault, PhD, Assistant Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Florida
ClinicalTrials.gov Identifier:
NCT04925076
Other Study ID Numbers:
  • IRB201800992-N
  • R01AA025337
First Posted:
Jun 14, 2021
Last Update Posted:
Aug 3, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Florida
alcohol effects
pain
Additional relevant MeSH terms:
Alcoholism
Ethanol

Study Results

No Results Posted as of Aug 3, 2022