Effects of Family History of Alcoholism and Sex on Alcohol AnalgesiaNCT04925076

Characterizing the Effects of Family History of Alcoholism on Alcohol Analgesia

A study testing Ethanol in people with Effects of Family History of Alcoholism and Sex on Alcohol Analgesia, run by University of Florida at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Effects of Family History of Alcoholism and Sex on Alcohol Analgesia
What is being tested?: Ethanol
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 125 participants
Where: 1 siteUnited States
Study dates: 20 Nov 2018to 1 Jun 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

History of chronic pain
Current use of opioids
Current major depression
History of any psychotic disorder
Undercontrolled hypertension or diabetes
History of neurologic disease

Show all 9Show fewer

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)

Trial locations and contacts

1 site in 1 country.

United States1 site

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

Other trials in United States

About this study

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
Being tested: Ethanol, Placebo
Keywords: alcohol effects, pain
Medical subject headings: Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EthanolDrug
A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.
PlaceboOther
A beverage that does not meaningfully increase breath alcohol concentration.

Study groups in NCT04925076
Study group	Role	What they receive
Family History Positive	Experimental	People reporting at least one parent with a history of alcohol problems. Receives: Drug: Ethanol; Other: Placebo
Family History Negative	Experimental	People who do not report having a parent with a history of alcohol problems. Receives: Drug: Ethanol; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Nov 20181 Jun 2023

First posted14 Jun 2021
Study start20 Nov 2018
Primary completion1 Jun 2023
Study completion1 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Effects of Family History of Alcoholism and Sex on Alcohol AnalgesiaStudies of the same condition, open and under way.
More trials run by University of FloridaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Model description: Participants will receive an active oral dose of alcohol or placebo in a counterbalanced manner.
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 125 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04925076
Sponsor's protocol ID: IRB201800992-N
Other IDs: R01AA025337
Status last verified: Jul 2024
First submitted: 8 Jun 2021
Last updated: 13 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 31891860
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.
PubMed 32472620
Cushnie AK, Bush NJ, Sevel LS, Stennett-Blackmon B, Farone A, Nixon SJ, Robinson ME, Boissoneault J. Insula under the influence: Alcohol-induced changes in resting state functional connectivity. Alcohol Clin Exp Res (Hoboken). 2025 Jun;49(6):1221-1232. doi: 10.1111/acer.70053. Epub 2025 Apr 19.
PubMed 40251982

Study at a glance

From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Characterizing the Effects of Family History of Alcoholism on Alcohol Analgesia
ClinicalTrials.gov ID: NCT04925076
Acronym / sponsor ID: IRB201800992-N
Conditions: Effects of Family History of Alcoholism and Sex on Alcohol Analgesia
Keywords: alcohol effects, pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 125 participants (actual)
Lead sponsor: University of FloridaUniversity, hospital or other
Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study start: 20 Nov 2018 (actual)
Primary completion: 1 Jun 2023 (actual)
Study completion: 1 Jun 2023 (actual)
First posted: 14 Jun 2021 (actual)
Results: Posted 13 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2
Model description: Participants will receive an active oral dose of alcohol or placebo in a counterbalanced manner.

Arm	Type	Receives
Family History Positive	Experimental	Drug: Ethanol, Other: PlaceboPeople reporting at least one parent with a history of alcohol problems.
Family History Negative	Experimental	Drug: Ethanol, Other: PlaceboPeople who do not report having a parent with a history of alcohol problems.

Who may qualify

Ages: 21 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (9 listed)

History of chronic pain
Current use of opioids
Current major depression
History of any psychotic disorder
Undercontrolled hypertension or diabetes

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EthanolA beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.	Drug	Family History Negative, Family History Positive
PlaceboA beverage that does not meaningfully increase breath alcohol concentration.	Other	Family History Negative, Family History Positive

Primary outcome

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Results and safety

Results posted to the registry on 13 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Family History Positive Men: Ethanol First, Then Placebo	10	10
Family History Negative Men: Ethanol First, Then Placebo	17	17
Family History Positive Men: Placebo First, Then Ethanol	12	12
Family History Negative Men: Placebo First, Then Ethanol	14	14
Family History Positive Women: Ethanol First, Then Placebo	12	12
Family History Negative Women: Ethanol First, Then Placebo	23	23
Family History Positive Women: Placebo First, Then Ethanol	18	18
Family History Negative Women: Placebo First, Then	19	19

Primary outcome: Heat Pain Threshold

Time frame: Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.). Mean (Standard Error). Unit: degrees celsius

Measure	Family History Positive Men n = 20	Family History Negative Men n = 30	Family History Positive Women n = 27	Family History Negative Women n = 35
Alcohol Condition	43.56 (.38)	43.63 (.311)	42.28 (.328)	43.94 (.288)
Placebo Condition	43.20 (.386)	43.43 (.315)	41.98 (.33)	43.75 (.29)

Family History Positive Men vs Family History Negative Men vs Family History Positive Women vs Family History Negative Women: p = .92, ANOVA
Family History Positive Men vs Family History Negative Men vs Family History Positive Women vs Family History Negative Women: p = .92, ANOVA
Family History Positive Men vs Family History Negative Men vs Family History Positive Women vs Family History Negative Women: p = .61, Chi-squared

Primary outcome: Heat Pain Tolerance

Time frame: Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.). Mean (Standard Error). Unit: degrees celsius

Measure	Family History Positive Men n = 20	Family History Negative Men n = 30	Family History Positive Women n = 27	Family History Negative Women n = 34
Alcohol Condition	48.33 (.331)	48.13 (.27)	46.65 (.285)	47.50 (.25)
Placebo Condition	48.18 (.339)	47.95 (.277)	46.57 (.29)	47.68 (.257)

Family History Positive Men vs Family History Negative Men vs Family History Positive Women vs Family History Negative Women: p = .38, ANOVA
Family History Positive Men vs Family History Negative Men vs Family History Positive Women vs Family History Negative Women: p = .27, ANOVA
Family History Positive Men vs Family History Negative Men vs Family History Positive Women vs Family History Negative Women: p = .70, ANOVA

Primary outcome: Heat Pain Intensity Ratings

Time frame: Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.). Mean (Standard Error). Unit: units on a VAS

Measure	Family History Positive Men n = 20	Family History Negative Men n = 30	Family History Positive Women n = 27	Family History Negative Women n = 34
Alcohol Condition	25.58 (3.43)	25.48 (2.81)	24.51 (2.98)	27.11 (2.64)
Placebo Condition	28.41 (3.37)	25.76 (2.75)	24.07 (2.90)	24.92 (2.58)

Family History Positive Men vs Family History Negative Men vs Family History Positive Women vs Family History Negative Women: p = .83, ANOVA
Family History Positive Men vs Family History Negative Men vs Family History Positive Women vs Family History Negative Women: p = .12, ANOVA
Family History Positive Men vs Family History Negative Men vs Family History Positive Women vs Family History Negative Women: p = .25, ANOVA

Primary outcome: Perceived Pain Relief

Time frame: Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.). Mean (Standard Error). Unit: units on a VAS

Measure	Family History Positive Men n = 20	Family History Negative Men n = 30	Family History Positive Women n = 27	Family History Negative Women n = 35
Alcohol Condition	33.44 (4.41)	32.18 (3.60)	35.64 (3.78)	37.60 (3.34)
Placebo Condition	13.63 (3.75)	13.76 (3.06)	14.83 (3.22)	11.61 (2.83)

Family History Positive Men vs Family History Negative Men vs Family History Positive Women vs Family History Negative Women: p = .36, ANOVA
Family History Positive Men vs Family History Negative Men vs Family History Positive Women vs Family History Negative Women: p = .24, ANOVA
Family History Positive Men vs Family History Negative Men vs Family History Positive Women vs Family History Negative Women: p = .60, ANOVA

Adverse events

Time frame: Duration of study participation (4-8 hours per study session, with at least 48 hours separating each session). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Family History Positive Men - Alcohol Condition	0 of 22 (0%)	0 of 22 (0%)	0 of 22
Family History Negative Men - Alcohol Condition	0 of 31 (0%)	0 of 31 (0%)	0 of 31
Family History Positive Women - Alcohol Condition	0 of 30 (0%)	0 of 30 (0%)	0 of 30
Family History Negative Women - Alcohol Condition	0 of 42 (0%)	0 of 42 (0%)	0 of 42
Family History Positive Men - Placebo Condition	0 of 22 (0%)	0 of 22 (0%)	0 of 22
Family History Negative Men - Placebo Condition	0 of 31 (0%)	0 of 31 (0%)	0 of 31
Family History Positive Women - Placebo Condition	0 of 30 (0%)	0 of 30 (0%)	0 of 30
Family History Negative Women - Placebo Condition	0 of 42 (0%)	0 of 42 (0%)	0 of 42

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 31891860Boissoneault 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.
Results publication: PubMed 32472620Sevel 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.
Derived from this study: PubMed 40251982Cushnie AK, Bush NJ, Sevel LS, Stennett-Blackmon B, Farone A, Nixon SJ, Robinson ME, Boissoneault J. Insula under the influence: Alcohol-induced changes in resting state functional connectivity. Alcohol Clin Exp Res (Hoboken). 2025 Jun;49(6):1221-1232. doi: 10.1111/acer.70053. Epub 2025 Apr 19.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jeff Boissoneault, PhD principal investigator

Assistant Professor

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Ethanol in people with Effects of Family History of Alcoholism and Sex on Alcohol Analgesia, run by University of Florida at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Heat Pain Threshold (time frame: Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.)). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04925076, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2024.