Trial Outcomes & Findings for Acute Alcohol Response In Bipolar Disorder: a fMRI Study (NCT NCT04063384)

Results Overview

Participants fill out self-report surveys \[specifically the Subjective Effects of Alcohol Scale (SEAS)\] on how they feel when they arrive to their beverage administration sessions (alcohol and placebo sessions). They then feel out the same self-report surveys on how intoxicated they feel during their beverage sessions (alcohol and placebo). Changes in how intoxicated they feel is calculated for both the alcohol and placebo condition (compared to how they felt pre-beverage). 4 subscores are calculated by summing individual items: positive valence/positive arousal (stimulation), SEAS positive valence/negative arousal (anxiolytic), negative valence/negative arousal (aggression/agitation), and negative valence/negative arousal (sedative effects). Summed subscores on the SEAS range between 0 and 40. Change scores can therefore range between -40 and 40 (post-beverage compared to pre-beverage feelings). Scores greater than 0 on any one subscale indicates feeling more effects of alcohol.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

up to 1 week

Results posted on

2025-12-11

Participant Flow

60 participants were recruited.

Participants were randomly assigned to receiving placebo first or alcohol beverage session first.

Participant milestones

Participant milestones
Measure	BD Alcohol First, Then Placebo Participants will be dosed to a 0.08g% blood alcohol concentration on alcohol day and then on a following day was dosed to \<.01 blood alcohol concentration (placebo day).	TD Alcohol First, Then Placebo Participants will be dosed to a 0.08g% blood alcohol concentration on alcohol day and then on a following day was dosed to \<.01 blood alcohol concentration (placebo day).	BD Placebo First, Then Alcohol Participants were dosed to \<.01 blood alcohol concentration (placebo day) for their first beverage, and then on a following day were dosed to a 0.08g% blood alcohol concentration (alcohol day).	TD Placebo First, Then Alcohol Participants were dosed to \<.01 blood alcohol concentration (placebo day) for their first beverage, and then on a following day were dosed to a 0.08g% blood alcohol concentration (alcohol day).
Overall Study STARTED	16	15	14	15
Overall Study COMPLETED	15	13	13	14
Overall Study NOT COMPLETED	1	2	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	BD Alcohol First, Then Placebo Participants will be dosed to a 0.08g% blood alcohol concentration on alcohol day and then on a following day was dosed to \<.01 blood alcohol concentration (placebo day).	TD Alcohol First, Then Placebo Participants will be dosed to a 0.08g% blood alcohol concentration on alcohol day and then on a following day was dosed to \<.01 blood alcohol concentration (placebo day).	BD Placebo First, Then Alcohol Participants were dosed to \<.01 blood alcohol concentration (placebo day) for their first beverage, and then on a following day were dosed to a 0.08g% blood alcohol concentration (alcohol day).	TD Placebo First, Then Alcohol Participants were dosed to \<.01 blood alcohol concentration (placebo day) for their first beverage, and then on a following day were dosed to a 0.08g% blood alcohol concentration (alcohol day).
Overall Study placebo manipulation issue	1	2	1	1

Baseline Characteristics

Acute Alcohol Response In Bipolar Disorder: a fMRI Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BD Alcohol First, Then Placebo n=15 Participants Participants will be dosed to a 0.08g% blood alcohol concentration on alcohol day and then on a following day was dosed to \<.01 blood alcohol concentration (placebo day).	TD Alcohol First, Then Placebo n=13 Participants Participants will be dosed to a 0.08g% blood alcohol concentration on alcohol day and then on a following day was dosed to \<.01 blood alcohol concentration (placebo day).	BD Placebo First, Then Alcohol n=13 Participants Participants were dosed to \<.01 blood alcohol concentration (placebo day) for their first beverage, and then on a following day were dosed to a 0.08g% blood alcohol concentration (alcohol day).	TD Placebo First, Then Alcohol n=13 Participants Participants were dosed to \<.01 blood alcohol concentration (placebo day) for their first beverage, and then on a following day were dosed to a 0.08g% blood alcohol concentration (alcohol day).	Total n=54 Participants Total of all reporting groups
Age, Continuous	23.3 years STANDARD_DEVIATION 1.8 • n=237 Participants	22.1 years STANDARD_DEVIATION 1.3 • n=243 Participants	23.5 years STANDARD_DEVIATION 1.7 • n=480 Participants	22.9 years STANDARD_DEVIATION 1.3 • n=639 Participants	22.9 years STANDARD_DEVIATION 1.6 • n=277 Participants
Sex: Female, Male Female	11 Participants n=237 Participants	8 Participants n=243 Participants	9 Participants n=480 Participants	7 Participants n=639 Participants	35 Participants n=277 Participants
Sex: Female, Male Male	4 Participants n=237 Participants	5 Participants n=243 Participants	4 Participants n=480 Participants	6 Participants n=639 Participants	19 Participants n=277 Participants
Race/Ethnicity, Customized Hispanic	4 Participants n=237 Participants	3 Participants n=243 Participants	7 Participants n=480 Participants	3 Participants n=639 Participants	17 Participants n=277 Participants
Race/Ethnicity, Customized Nonhispanic White	10 Participants n=237 Participants	6 Participants n=243 Participants	3 Participants n=480 Participants	4 Participants n=639 Participants	23 Participants n=277 Participants
Race/Ethnicity, Customized Asian	0 Participants n=237 Participants	3 Participants n=243 Participants	2 Participants n=480 Participants	5 Participants n=639 Participants	10 Participants n=277 Participants
Race/Ethnicity, Customized More than one race	1 Participants n=237 Participants	1 Participants n=243 Participants	1 Participants n=480 Participants	1 Participants n=639 Participants	4 Participants n=277 Participants

PRIMARY outcome

Timeframe: up to 1 week

Population: Excluded participants with placebo manipulation issues. One TD participant was excluded because they later revealed a past depressive episode.

Participants fill out self-report surveys \[specifically the Subjective Effects of Alcohol Scale (SEAS)\] on how they feel when they arrive to their beverage administration sessions (alcohol and placebo sessions). They then feel out the same self-report surveys on how intoxicated they feel during their beverage sessions (alcohol and placebo). Changes in how intoxicated they feel is calculated for both the alcohol and placebo condition (compared to how they felt pre-beverage). 4 subscores are calculated by summing individual items: positive valence/positive arousal (stimulation), SEAS positive valence/negative arousal (anxiolytic), negative valence/negative arousal (aggression/agitation), and negative valence/negative arousal (sedative effects). Summed subscores on the SEAS range between 0 and 40. Change scores can therefore range between -40 and 40 (post-beverage compared to pre-beverage feelings). Scores greater than 0 on any one subscale indicates feeling more effects of alcohol.

Outcome measures

Outcome measures
Measure	BD Alcohol First, Then Placebo n=15 Participants Participants will be dosed to a 0.08g% blood alcohol concentration on alcohol day and then on a following day was dosed to \<.01 blood alcohol concentration (placebo day).	TD Alcohol First, Then Placebo n=13 Participants Participants will be dosed to a 0.08g% blood alcohol concentration on alcohol day and then on a following day was dosed to \<.01 blood alcohol concentration (placebo day).	BD Placebo First, Then Alcohol n=13 Participants Participants were dosed to \<.01 blood alcohol concentration (placebo day) for their first beverage, and then on a following day were dosed to a 0.08g% blood alcohol concentration (alcohol day).	TD Placebo First, Then Alcohol n=13 Participants Participants were dosed to \<.01 blood alcohol concentration (placebo day) for their first beverage, and then on a following day were dosed to a 0.08g% blood alcohol concentration (alcohol day).
Level of Intoxication (Subjective Response) on Each Condition Day After Drinking Relative to How They Felt When Arriving to the Lab on That Respective Day )Prior to Drinking) SEAS positive valence/positive arousal: alcohol session	7.3 score on a scale Standard Error 1.2	3.6 score on a scale Standard Error 1.0	15.4 score on a scale Standard Error 2.3	6.3 score on a scale Standard Error 1.3
Level of Intoxication (Subjective Response) on Each Condition Day After Drinking Relative to How They Felt When Arriving to the Lab on That Respective Day )Prior to Drinking) SEAS positive valence/positive arousal: placebo session	4.1 score on a scale Standard Error 1.1	2.3 score on a scale Standard Error 0.98	5.3 score on a scale Standard Error 1.8	3.3 score on a scale Standard Error 1.1
Level of Intoxication (Subjective Response) on Each Condition Day After Drinking Relative to How They Felt When Arriving to the Lab on That Respective Day )Prior to Drinking) SEAS positive valence/negative arousal: alcohol session	-1.4 score on a scale Standard Error 1.6	-5.3 score on a scale Standard Error 0.9	7.1 score on a scale Standard Error 2.1	0.9 score on a scale Standard Error 1.4
Level of Intoxication (Subjective Response) on Each Condition Day After Drinking Relative to How They Felt When Arriving to the Lab on That Respective Day )Prior to Drinking) SEAS positive valence/negative arousal: placebo session	1.7 score on a scale Standard Error 0.98	-0.42 score on a scale Standard Error 0.47	-2.3 score on a scale Standard Error 0.97	-2.96 score on a scale Standard Error 4.7

PRIMARY outcome

Timeframe: up to 1 week

Population: Analysis was completed prior to study completion.

Neural responses to emotional stimuli during the alcohol and placebo sessions were modeled. Fisher transformed correlation coefficients between regions of interest while viewing emotional stimuli (compared to squares) were calculated for each beverage session and data extracted for posthoc analysis. Values represent change scores in correlation coefficients during each beverage session.

Outcome measures

Outcome measures
Measure	BD Alcohol First, Then Placebo n=11 Participants Participants will be dosed to a 0.08g% blood alcohol concentration on alcohol day and then on a following day was dosed to \<.01 blood alcohol concentration (placebo day).	TD Alcohol First, Then Placebo n=12 Participants Participants will be dosed to a 0.08g% blood alcohol concentration on alcohol day and then on a following day was dosed to \<.01 blood alcohol concentration (placebo day).	BD Placebo First, Then Alcohol n=12 Participants Participants were dosed to \<.01 blood alcohol concentration (placebo day) for their first beverage, and then on a following day were dosed to a 0.08g% blood alcohol concentration (alcohol day).	TD Placebo First, Then Alcohol n=13 Participants Participants were dosed to \<.01 blood alcohol concentration (placebo day) for their first beverage, and then on a following day were dosed to a 0.08g% blood alcohol concentration (alcohol day).
Change in Functional Coupling Between Regions of Interest During Viewing of Emotional Stimuli (Neural Responses While Viewing Emotional Stimuli Were Contrasted Against Neural Responses When Viewing Squares) Insula:sgACC functional connectivity: placebo	0.001 Change scores in correlation coefficient Standard Error 0.02	-0.0003 Change scores in correlation coefficient Standard Error 0.02	0.05 Change scores in correlation coefficient Standard Error 0.01	-0.006 Change scores in correlation coefficient Standard Error 0.02
Change in Functional Coupling Between Regions of Interest During Viewing of Emotional Stimuli (Neural Responses While Viewing Emotional Stimuli Were Contrasted Against Neural Responses When Viewing Squares) Left NAc:vmPFC functional connectivity: alcohol	-0.006 Change scores in correlation coefficient Standard Error 0.03	-0.05 Change scores in correlation coefficient Standard Error 0.02	0.01 Change scores in correlation coefficient Standard Error 0.02	-0.02 Change scores in correlation coefficient Standard Error 0.03
Change in Functional Coupling Between Regions of Interest During Viewing of Emotional Stimuli (Neural Responses While Viewing Emotional Stimuli Were Contrasted Against Neural Responses When Viewing Squares) Insula:sgACC functional connectivity: alcohol	-0.04 Change scores in correlation coefficient Standard Error 0.02	0.03 Change scores in correlation coefficient Standard Error 0.02	0.002 Change scores in correlation coefficient Standard Error 0.02	0.05 Change scores in correlation coefficient Standard Error 0.03
Change in Functional Coupling Between Regions of Interest During Viewing of Emotional Stimuli (Neural Responses While Viewing Emotional Stimuli Were Contrasted Against Neural Responses When Viewing Squares) Left NAc:vmPFC functional connectivity: placebo	-0.06 Change scores in correlation coefficient Standard Error 0.02	-0.002 Change scores in correlation coefficient Standard Error 0.02	-0.014 Change scores in correlation coefficient Standard Error 0.03	0.003 Change scores in correlation coefficient Standard Error 0.02

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Elizabeth Lippard

University of Texas at Austin

Phone: 512-495-5216

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place