Back to results

Characterizing the Effects of Family History of Alcoholism on Alcohol Analgesia

Primary Purpose

Effects of Family History of Alcoholism and Sex on Alcohol Analgesia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Ethanol

Placebo

About this trial

This is an interventional basic science trial for Effects of Family History of Alcoholism and Sex on Alcohol Analgesia focused on measuring alcohol effects, pain

Eligibility Criteria

21 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

Center for Pain Research and Behavioral Health at UF Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Family History Positive

Family History Negative

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

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.

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.

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".

Change in Activity of Pain-related Brain Regions during Painful Stimulation

Functional activation of brain regions involved in pain response

Change in Connectivity of Pain-related Brain Regions during Painful Stimulation

Functional connectivity of brain regions involved in pain response

Secondary Outcome Measures

Full Information

NCT ID

NCT04925076

First Posted

June 8, 2021

Last Updated

August 14, 2023

Sponsor

University of Florida

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

1. Study Identification

Unique Protocol Identification Number

NCT04925076

Brief Title

Characterizing the Effects of Family History of Alcoholism on Alcohol Analgesia

Official Title

Characterizing the Effects of Family History of Alcoholism on Alcohol Analgesia

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

November 20, 2018 (Actual)

Primary Completion Date

June 1, 2023 (Actual)

Study Completion Date

June 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Florida

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Effects of Family History of Alcoholism and Sex on Alcohol Analgesia

Keywords

alcohol effects, pain

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

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

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

125 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Family History Positive

Arm Type

Experimental

Arm Description

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

Arm Title

Family History Negative

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Ethanol

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

A beverage that does not meaningfully increase breath alcohol concentration.

Primary Outcome Measure Information:

Title

Change in Heat Pain Threshold

Description

Time Frame