Characterizing the Effects of Family History of Alcoholism on Alcohol Analgesia

August 14, 2023 updated by: University of Florida
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

125

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
        • Center for Pain Research and Behavioral Health at UF Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Perceived 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. 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 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.
Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.)
Change in 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.
Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.)
Change in Heat Pain 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 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 Activity of Pain-related Brain Regions during Painful Stimulation
Time Frame: Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.)
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
Time Frame: Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.)
Functional connectivity of brain regions involved in pain response
Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

  • Principal Investigator: Jeff Boissoneault, PhD, Assistant Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2018

Primary Completion (Actual)

June 1, 2023

Study Completion (Actual)

June 1, 2023

Study Registration Dates

First Submitted

June 8, 2021

First Submitted That Met QC Criteria

June 8, 2021

First Posted (Actual)

June 14, 2021

Study Record Updates

Last Update Posted (Actual)

August 15, 2023

Last Update Submitted That Met QC Criteria

August 14, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB201800992-N
  • R01AA025337 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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