Trial Outcomes & Findings for Characterizing the Effects of Family History of Alcoholism on Alcohol Analgesia (NCT NCT04925076)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

125 participants

Primary outcome timeframe

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

Results posted on

2024-08-13

Participant Flow

Participant milestones

Participant milestones
Measure	Family History Positive Men: Ethanol First, Then Placebo Men with at least one parent with a history of alcohol problems, randomized to received ethanol first, followed by placebo. The first laboratory session lasted 4-8 hours, followed by a minimum 48 hour gap, and the second laboratory session lasted 4-8 hours. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.	Family History Negative Men: Ethanol First, Then Placebo Men without a parent with a history of alcohol problems, randomized to received ethanol first, followed by placebo. The first laboratory session lasted 4-8 hours, followed by a minimum 48 hour gap, and the second laboratory session lasted 4-8 hours. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.	Family History Positive Men: Placebo First, Then Ethanol Men with at least one parent with a history of alcohol problems, randomized to received placebo first, followed by ethanol. The first laboratory session lasted 4-8 hours, followed by a minimum 48 hour gap, and the second laboratory session lasted 4-8 hours. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.	Family History Negative Men: Placebo First, Then Ethanol Men without a parent with a history of alcohol problems, randomized to received placebo first, followed by ethanol. The first laboratory session lasted 4-8 hours, followed by a minimum 48 hour gap, and the second laboratory session lasted 4-8 hours. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.	Family History Positive Women: Ethanol First, Then Placebo Women with at least one parent with a history of alcohol problems, randomized to received ethanol first, followed by placebo. The first laboratory session lasted 4-8 hours, followed by a minimum 48 hour gap, and the second laboratory session lasted 4-8 hours. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.	Family History Negative Women: Ethanol First, Then Placebo Women without a parent with a history of alcohol problems, randomized to received ethanol first, followed by placebo. The first laboratory session lasted 4-8 hours, followed by a minimum 48 hour gap, and the second laboratory session lasted 4-8 hours. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.	Family History Positive Women: Placebo First, Then Ethanol Women with at least one parent with a history of alcohol problems, randomized to received placebo first, followed by ethanol. The first laboratory session lasted 4-8 hours, followed by a minimum 48 hour gap, and the second laboratory session lasted 4-8 hours. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.	Family History Negative Women: Placebo First, Then Women without a parent with a history of alcohol problems, randomized to received placebo first, followed by ethanol. The first laboratory session lasted 4-8 hours, followed by a minimum 48 hour gap, and the second laboratory session lasted 4-8 hours. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.
Overall Study STARTED	10	17	12	14	12	23	18	19
Overall Study COMPLETED	10	17	12	14	12	23	18	19
Overall Study NOT COMPLETED	0	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Characterizing the Effects of Family History of Alcoholism on Alcohol Analgesia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Family History Positive Men n=22 Participants Men reporting at least one parent with a history of alcohol problems. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.	Family History Negative Men n=31 Participants Men who do not report having a parent with a history of alcohol problems. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.	Family History Positive Women n=30 Participants Women reporting at least one parent with a history of alcohol problems. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.	Family History Negative Women n=42 Participants Women who do not report having a parent with a history of alcohol problems. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.	Total n=125 Participants Total of all reporting groups
Age, Continuous	27.09 years STANDARD_DEVIATION 4.83 • n=5 Participants	27.23 years STANDARD_DEVIATION 5.64 • n=7 Participants	25.13 years STANDARD_DEVIATION 4.12 • n=5 Participants	26.19 years STANDARD_DEVIATION 4.40 • n=4 Participants	25.75 years STANDARD_DEVIATION 4.29 • n=21 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	30 Participants n=5 Participants	42 Participants n=4 Participants	72 Participants n=21 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	31 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	53 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants	11 Participants n=4 Participants	27 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants	26 Participants n=7 Participants	22 Participants n=5 Participants	31 Participants n=4 Participants	97 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	5 Participants n=4 Participants	12 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants	26 Participants n=7 Participants	24 Participants n=5 Participants	35 Participants n=4 Participants	102 Participants n=21 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	6 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment United States	22 participants n=5 Participants	31 participants n=7 Participants	30 participants n=5 Participants	42 participants n=4 Participants	125 participants n=21 Participants
Alcohol Use Disorders Identification Test	4.45 total score STANDARD_DEVIATION 2.09 • n=5 Participants	4.68 total score STANDARD_DEVIATION 1.45 • n=7 Participants	4.70 total score STANDARD_DEVIATION 1.99 • n=5 Participants	4.64 total score STANDARD_DEVIATION 1.61 • n=4 Participants	4.63 total score STANDARD_DEVIATION 1.74 • n=21 Participants
Quantity-Frequency Index	.55 oz. absolute ethanol consumed per day STANDARD_DEVIATION .40 • n=5 Participants	.47 oz. absolute ethanol consumed per day STANDARD_DEVIATION .27 • n=7 Participants	.44 oz. absolute ethanol consumed per day STANDARD_DEVIATION .32 • n=5 Participants	.44 oz. absolute ethanol consumed per day STANDARD_DEVIATION .27 • n=4 Participants	.47 oz. absolute ethanol consumed per day STANDARD_DEVIATION .31 • n=21 Participants
Max Quantity	4.54 oz. absolute ethanol STANDARD_DEVIATION 2.66 • n=5 Participants	5.05 oz. absolute ethanol STANDARD_DEVIATION 2.51 • n=7 Participants	4.33 oz. absolute ethanol STANDARD_DEVIATION 2.50 • n=5 Participants	4.16 oz. absolute ethanol STANDARD_DEVIATION 2.11 • n=4 Participants	4.49 oz. absolute ethanol STANDARD_DEVIATION 2.41 • n=21 Participants
Expectancies for Alcohol Analgesia	35.64 average score STANDARD_DEVIATION 26.20 • n=5 Participants	44.46 average score STANDARD_DEVIATION 22.78 • n=7 Participants	46.81 average score STANDARD_DEVIATION 19.40 • n=5 Participants	42.53 average score STANDARD_DEVIATION 23.27 • n=4 Participants	42.82 average score STANDARD_DEVIATION 22.68 • n=21 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Family History Positive Men n=20 Participants Men reporting at least one parent with a history of alcohol problems. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.	Family History Negative Men n=30 Participants Men who do not report having a parent with a history of alcohol problems. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.	Family History Positive Women n=27 Participants Women reporting at least one parent with a history of alcohol problems. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.	Family History Negative Women n=35 Participants Women who do not report having a parent with a history of alcohol problems. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.
Heat Pain Threshold Alcohol Condition	43.56 degrees celsius Standard Error .38	43.63 degrees celsius Standard Error .311	42.28 degrees celsius Standard Error .328	43.94 degrees celsius Standard Error .288
Heat Pain Threshold Placebo Condition	43.20 degrees celsius Standard Error .386	43.43 degrees celsius Standard Error .315	41.98 degrees celsius Standard Error .33	43.75 degrees celsius Standard Error .29

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Family History Positive Men n=20 Participants Men reporting at least one parent with a history of alcohol problems. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.	Family History Negative Men n=30 Participants Men who do not report having a parent with a history of alcohol problems. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.	Family History Positive Women n=27 Participants Women reporting at least one parent with a history of alcohol problems. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.	Family History Negative Women n=34 Participants Women who do not report having a parent with a history of alcohol problems. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.
Heat Pain Tolerance Alcohol Condition	48.33 degrees celsius Standard Error .331	48.13 degrees celsius Standard Error .27	46.65 degrees celsius Standard Error .285	47.50 degrees celsius Standard Error .25
Heat Pain Tolerance Placebo Condition	48.18 degrees celsius Standard Error .339	47.95 degrees celsius Standard Error .277	46.57 degrees celsius Standard Error .29	47.68 degrees celsius Standard Error .257

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Family History Positive Men n=20 Participants Men reporting at least one parent with a history of alcohol problems. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.	Family History Negative Men n=30 Participants Men who do not report having a parent with a history of alcohol problems. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.	Family History Positive Women n=27 Participants Women reporting at least one parent with a history of alcohol problems. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.	Family History Negative Women n=34 Participants Women who do not report having a parent with a history of alcohol problems. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.
Heat Pain Intensity Ratings Alcohol Condition	25.58 units on a VAS Standard Error 3.43	25.48 units on a VAS Standard Error 2.81	24.51 units on a VAS Standard Error 2.98	27.11 units on a VAS Standard Error 2.64
Heat Pain Intensity Ratings Placebo Condition	28.41 units on a VAS Standard Error 3.37	25.76 units on a VAS Standard Error 2.75	24.07 units on a VAS Standard Error 2.90	24.92 units on a VAS Standard Error 2.58

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Family History Positive Men n=20 Participants Men reporting at least one parent with a history of alcohol problems. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.	Family History Negative Men n=30 Participants Men who do not report having a parent with a history of alcohol problems. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.	Family History Positive Women n=27 Participants Women reporting at least one parent with a history of alcohol problems. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.	Family History Negative Women n=35 Participants Women who do not report having a parent with a history of alcohol problems. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.
Perceived Pain Relief Alcohol Condition	33.44 units on a VAS Standard Error 4.41	32.18 units on a VAS Standard Error 3.60	35.64 units on a VAS Standard Error 3.78	37.60 units on a VAS Standard Error 3.34
Perceived Pain Relief Placebo Condition	13.63 units on a VAS Standard Error 3.75	13.76 units on a VAS Standard Error 3.06	14.83 units on a VAS Standard Error 3.22	11.61 units on a VAS Standard Error 2.83

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Family History Positive Men n=19 Participants Men reporting at least one parent with a history of alcohol problems. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.	Family History Negative Men n=27 Participants Men who do not report having a parent with a history of alcohol problems. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.	Family History Positive Women n=21 Participants Women reporting at least one parent with a history of alcohol problems. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.	Family History Negative Women n=30 Participants Women who do not report having a parent with a history of alcohol problems. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.
Dorsolateral Prefrontal Cortex Activation Alcohol Condition	-.01 beta weight Standard Error .054	-.02 beta weight Standard Error .045	.04 beta weight Standard Error .051	.097 beta weight Standard Error .043
Dorsolateral Prefrontal Cortex Activation Placebo Condition	.099 beta weight Standard Error .047	.019 beta weight Standard Error .039	.082 beta weight Standard Error .044	.115 beta weight Standard Error .037

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Family History Positive Men n=19 Participants Men reporting at least one parent with a history of alcohol problems. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.	Family History Negative Men n=27 Participants Men who do not report having a parent with a history of alcohol problems. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.	Family History Positive Women n=21 Participants Women reporting at least one parent with a history of alcohol problems. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.	Family History Negative Women n=30 Participants Women who do not report having a parent with a history of alcohol problems. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.
Hypothalamus Activation Alcohol Condition	-.096 beta weight Standard Error .0449	-.047 beta weight Standard Error .041	.007 beta weight Standard Error .046	-.036 beta weight Standard Error .039
Hypothalamus Activation Placebo Condition	-.083 beta weight Standard Error .047	.018 beta weight Standard Error .04	-.023 beta weight Standard Error .045	-.022 beta weight Standard Error .038

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Family History Positive Men n=19 Participants Men reporting at least one parent with a history of alcohol problems. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.	Family History Negative Men n=27 Participants Men who do not report having a parent with a history of alcohol problems. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.	Family History Positive Women n=21 Participants Women reporting at least one parent with a history of alcohol problems. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.	Family History Negative Women n=30 Participants Women who do not report having a parent with a history of alcohol problems. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.
Medial Prefrontal Cortex Activation Alcohol Condition	-.173 beta weight Standard Error .081	-.163 beta weight Standard Error .068	-.096 beta weight Standard Error .077	-.173 beta weight Standard Error .065
Medial Prefrontal Cortex Activation Placebo Condition	-.183 beta weight Standard Error .075	-.201 beta weight Standard Error .063	-.189 beta weight Standard Error .072	-.15 beta weight Standard Error .06

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Family History Positive Men n=19 Participants Men reporting at least one parent with a history of alcohol problems. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.	Family History Negative Men n=27 Participants Men who do not report having a parent with a history of alcohol problems. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.	Family History Positive Women n=21 Participants Women reporting at least one parent with a history of alcohol problems. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.	Family History Negative Women n=30 Participants Women who do not report having a parent with a history of alcohol problems. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.
Nucleus Accumbens Activation Alcohol Condition	-.037 beta weight Standard Error .041	.055 beta weight Standard Error .034	.075 beta weight Standard Error .039	.131 beta weight Standard Error .033
Nucleus Accumbens Activation Placebo Condition	.091 beta weight Standard Error .043	.103 beta weight Standard Error .036	.092 beta weight Standard Error .041	.155 beta weight Standard Error .034

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Family History Positive Men n=19 Participants Men reporting at least one parent with a history of alcohol problems. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.	Family History Negative Men n=27 Participants Men who do not report having a parent with a history of alcohol problems. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.	Family History Positive Women n=21 Participants Women reporting at least one parent with a history of alcohol problems. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.	Family History Negative Women n=30 Participants Women who do not report having a parent with a history of alcohol problems. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.
Periaqueductal Gray Activation Alcohol Condition	-.162 beta weight Standard Error .063	-.089 beta weight Standard Error .053	.055 beta weight Standard Error .060	.052 beta weight Standard Error .05
Periaqueductal Gray Activation Placebo Condition	.012 beta weight Standard Error .069	-.038 beta weight Standard Error .058	.036 beta weight Standard Error .066	.059 beta weight Standard Error .055

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Family History Positive Men n=19 Participants Men reporting at least one parent with a history of alcohol problems. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.	Family History Negative Men n=27 Participants Men who do not report having a parent with a history of alcohol problems. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.	Family History Positive Women n=21 Participants Women reporting at least one parent with a history of alcohol problems. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.	Family History Negative Women n=30 Participants Women who do not report having a parent with a history of alcohol problems. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.
Anterior Cingulate Cortex Activation Alcohol Condition	.020 beta weight Standard Error .046	.045 beta weight Standard Error .038	.082 beta weight Standard Error .044	.040 beta weight Standard Error .037
Anterior Cingulate Cortex Activation Placebo Condition	.049 beta weight Standard Error .044	.038 beta weight Standard Error .037	.066 beta weight Standard Error .042	.080 beta weight Standard Error .035

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Family History Positive Men n=19 Participants Men reporting at least one parent with a history of alcohol problems. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.	Family History Negative Men n=27 Participants Men who do not report having a parent with a history of alcohol problems. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.	Family History Positive Women n=21 Participants Women reporting at least one parent with a history of alcohol problems. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.	Family History Negative Women n=30 Participants Women who do not report having a parent with a history of alcohol problems. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.
Amgydala Activation Alcohol Condition	-.155 beta weight Standard Error .055	-.039 beta weight Standard Error .046	.013 beta weight Standard Error .052	-.061 beta weight Standard Error .044
Amgydala Activation Placebo Condition	-.050 beta weight Standard Error .048	-.007 beta weight Standard Error .040	.011 beta weight Standard Error .046	-.054 beta weight Standard Error .038

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Family History Positive Men n=19 Participants Men reporting at least one parent with a history of alcohol problems. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.	Family History Negative Men n=27 Participants Men who do not report having a parent with a history of alcohol problems. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.	Family History Positive Women n=21 Participants Women reporting at least one parent with a history of alcohol problems. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.	Family History Negative Women n=30 Participants Women who do not report having a parent with a history of alcohol problems. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.
Hippocampus Activation Alcohol Condition	-.154 beta weight Standard Error .048	-.130 beta weight Standard Error .041	-.116 beta weight Standard Error .046	-.128 beta weight Standard Error .039
Hippocampus Activation Placebo Condition	-.074 beta weight Standard Error .046	-.083 beta weight Standard Error .039	-.145 beta weight Standard Error .044	-.158 beta weight Standard Error .037

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Family History Positive Men n=19 Participants Men reporting at least one parent with a history of alcohol problems. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.	Family History Negative Men n=27 Participants Men who do not report having a parent with a history of alcohol problems. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.	Family History Positive Women n=21 Participants Women reporting at least one parent with a history of alcohol problems. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.	Family History Negative Women n=30 Participants Women who do not report having a parent with a history of alcohol problems. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.
Insula Activation Alcohol Condition	.220 beta weight Standard Error .054	.286 beta weight Standard Error .045	.270 beta weight Standard Error .051	.318 beta weight Standard Error .043
Insula Activation Placebo Condition	.389 beta weight Standard Error .055	.298 beta weight Standard Error .046	.329 beta weight Standard Error .052	.312 beta weight Standard Error .044

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Family History Positive Men n=19 Participants Men reporting at least one parent with a history of alcohol problems. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.	Family History Negative Men n=27 Participants Men who do not report having a parent with a history of alcohol problems. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.	Family History Positive Women n=21 Participants Women reporting at least one parent with a history of alcohol problems. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.	Family History Negative Women n=30 Participants Women who do not report having a parent with a history of alcohol problems. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.
Postcentral Gyrus Activation Alcohol Condition	-.139 beta weight Standard Error .046	-.038 beta weight Standard Error .039	-.068 beta weight Standard Error .044	-.041 beta weight Standard Error .37
Postcentral Gyrus Activation Placebo Condition	-.053 beta weight Standard Error .048	-.085 beta weight Standard Error .041	-.048 beta weight Standard Error .046	-.077 beta weight Standard Error .039

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Family History Positive Men n=19 Participants Men reporting at least one parent with a history of alcohol problems. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.	Family History Negative Men n=27 Participants Men who do not report having a parent with a history of alcohol problems. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.	Family History Positive Women n=21 Participants Women reporting at least one parent with a history of alcohol problems. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.	Family History Negative Women n=30 Participants Women who do not report having a parent with a history of alcohol problems. Ethanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. Placebo: A beverage that does not meaningfully increase breath alcohol concentration.
Thalamus Activation Placebo Condition	-.033 beta weight Standard Error .053	-.027 beta weight Standard Error .044	.066 beta weight Standard Error .050	-.029 beta weight Standard Error .042
Thalamus Activation Alcohol Condition	-.141 beta weight Standard Error .059	-.076 beta weight Standard Error .049	.023 beta weight Standard Error .056	-.022 beta weight Standard Error .047

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jeff Boissoneault, PhD

University of Minnesota

Phone: 612-624-7357

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place