Adults 21 to 26, any sex, with Bipolar Disorder or Alcohol Drinking. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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)Primary· up to 1 week
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
SEAS positive valence/positive arousal: alcohol session
Group
Value
95% CI
BD Alcohol First, Then Placebo
7.3
± 1.2
TD Alcohol First, Then Placebo
3.6
± 1.0
BD Placebo First, Then Alcohol
15.4
± 2.3
TD Placebo First, Then Alcohol
6.3
± 1.3
SEAS positive valence/positive arousal: placebo session
Group
Value
95% CI
BD Alcohol First, Then Placebo
4.1
± 1.1
TD Alcohol First, Then Placebo
2.3
± 0.98
BD Placebo First, Then Alcohol
5.3
± 1.8
TD Placebo First, Then Alcohol
3.3
± 1.1
SEAS positive valence/negative arousal: alcohol session
Group
Value
95% CI
BD Alcohol First, Then Placebo
-1.4
± 1.6
TD Alcohol First, Then Placebo
-5.3
± 0.9
BD Placebo First, Then Alcohol
7.1
± 2.1
TD Placebo First, Then Alcohol
0.9
± 1.4
SEAS positive valence/negative arousal: placebo session
Group
Value
95% CI
BD Alcohol First, Then Placebo
1.7
± 0.98
TD Alcohol First, Then Placebo
-0.42
± 0.47
BD Placebo First, Then Alcohol
-2.3
± 0.97
TD Placebo First, Then Alcohol
-2.96
± 4.7
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)Primary· up to 1 week
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.
Insula:sgACC functional connectivity: alcohol
Group
Value
95% CI
BD Alcohol First, Then Placebo
-0.04
± 0.02
TD Alcohol First, Then Placebo
0.03
± 0.02
BD Placebo First, Then Alcohol
0.002
± 0.02
TD Placebo First, Then Alcohol
0.05
± 0.03
Insula:sgACC functional connectivity: placebo
Group
Value
95% CI
BD Alcohol First, Then Placebo
0.001
± 0.02
TD Alcohol First, Then Placebo
-0.0003
± 0.02
BD Placebo First, Then Alcohol
0.05
± 0.01
TD Placebo First, Then Alcohol
-0.006
± 0.02
Left NAc:vmPFC functional connectivity: alcohol
Group
Value
95% CI
BD Alcohol First, Then Placebo
-0.006
± 0.03
TD Alcohol First, Then Placebo
-0.05
± 0.02
BD Placebo First, Then Alcohol
0.01
± 0.02
TD Placebo First, Then Alcohol
-0.02
± 0.03
Left NAc:vmPFC functional connectivity: placebo
Group
Value
95% CI
BD Alcohol First, Then Placebo
-0.06
± 0.02
TD Alcohol First, Then Placebo
-0.002
± 0.02
BD Placebo First, Then Alcohol
-0.014
± 0.03
TD Placebo First, Then Alcohol
0.003
± 0.02
Sponsor's own description
Alcohol use disorders (AUDs) affect up to 60% of individuals with bipolar disorder during their lifetime-a rate 3 to 5 times higher than what occurs in the general population. The mechanisms that contribute to elevated rates of comorbidity are not known. Early identification in individuals with bipolar disorder who are at risk for AUDs could inform novel intervention strategies and improve life-long outcomes. The primary objective of this protocol is to use alcohol administration procedures and functional MRI techniques to investigate subjective response to alcohol, compared to placebo, and relationship with functional responses of, and connectivity among, brain regions in ventral prefrontal emotional networks in young adults with bipolar disorder and healthy comparison young adults. Baseline clinical and structural MRI assessments will be completed in 30 bipolar and 30 healthy young adults (21-26 years of age, 50% women). Then, following standard beverage administration procedures, participants will complete within-person, counter-balanced, fMRI scans and complete measures of subjective response to alcohol while under the influence of alcohol or placebo. Specifically, individual differences in the experience of stimulating, sedative, and anxiolytic effects of alcohol (measured with self-report surveys) and individual differences in neural responses to alcohol within ventral prefrontal emotional networks will be investigated and differences in bipolar disorder compared to healthy participants assessed. Functional MRI scans during a continuous performance task with emotional and neutral distractors (CPT-END) and at rest will be collected while under the influence of alcohol and placebo and compared. Experience of stimulating, sedative, and anxiolytic effects of alcohol from self-report survey data and neural responses to emotional stimuli while under the influence of alcohol compared to placebo will be the primary data outcomes assessed. Additionally, associations between subjective and neural response to alcohol and drinking patterns will be explored (secondary outcomes). The primary endpoint of the study will be after completion of both alcohol and placebo beverage conditions.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Texas at Austin
Last refreshed: 11 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04063384.