Trial results for a study investigating acute alcohol response in Bipolar Disorder were posted on ClinicalTrials.gov on 2025-11-19, involving 60 participants.
Background
Alcohol use disorders (AUDs) affect up to 60% of individuals with bipolar disorder (BD) during their lifetime, a rate significantly higher than in the general population. The underlying mechanisms contributing to these elevated rates of comorbidity are not fully understood. Early identification of individuals with bipolar disorder who are at risk for AUDs could inform the development of novel intervention strategies and potentially improve long-term outcomes. This study aimed to investigate the subjective response to alcohol, compared to placebo, using alcohol administration procedures and functional MRI techniques.
Trial design
This completed study, designated as Phase NA, enrolled 60 participants to investigate conditions including Bipolar Disorder, Alcohol Drinking, and Alcohol Use Disorder. The trial examined subjective response to alcohol compared to placebo. Participants were divided into groups, including those with bipolar disorder (BD) and typically developing (TD) individuals, who received alcohol or placebo in a crossover design (alcohol first, then placebo; or placebo first, then alcohol).
Key results
The trial reported several key measurements related to the level of intoxication (subjective response) on each condition day after drinking, relative to how participants felt when arriving at the lab prior to drinking:
- For the first set of measurements for "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)":
- In the "BD Alcohol First, Then Placebo" group, the mean score was 7.3 (Standard Error 1.2) on a scale.
- In the "TD Alcohol First, Then Placebo" group, the mean score was 3.6 (Standard Error 1.0) on a scale.
- In the "BD Placebo First, Then Alcohol" group, the mean score was 15.4 (Standard Error 2.3) on a scale.
- In the "TD Placebo First, Then Alcohol" group, the mean score was 6.3 (Standard Error 1.3) on a scale.
- For a second set of measurements for the same outcome title:
- In the "BD Alcohol First, Then Placebo" group, the mean score was 4.1 (Standard Error 1.1) on a scale.
- In the "TD Alcohol First, Then Placebo" group, the mean score was 2.3 (Standard Error 0.98) on a scale.
- In the "BD Placebo First, Then Alcohol" group, the mean score was 5.3 (Standard Error 1.8) on a scale.
- In the "TD Placebo First, Then Alcohol" group, the mean score was 3.3 (Standard Error 1.1) on a scale.
- For a third set of measurements for the same outcome title:
- In the "BD Alcohol First, Then Placebo" group, the mean score was -1.4 (Standard Error 1.6) on a scale.
- In the "TD Alcohol First, Then Placebo" group, the mean score was -5.3 (Standard Error 0.9) on a scale.
- In the "BD Placebo First, Then Alcohol" group, the mean score was 7.1 (Standard Error 2.1) on a scale.
- In the "TD Placebo First, Then Alcohol" group, the mean score was 0.9 (Standard Error 1.4) on a scale.
Key analyses performed included:
- A Mixed Models Analysis yielded a p-value of 0.05.
- Another Mixed Models Analysis yielded a p-value of 0.004. This analysis noted that the sample size (n = 23 with bipolar disorder, n = 24 healthy comparison participants), at an alpha = 0.05, provided > 80% statistical power to detect a within-subject effect size (ES) d ≥ 0.6 in both subgroups and a between-group ES d ≥ 0.8 in this fMRI analysis.
What this means
The posted results indicate differences in subjective intoxication levels between individuals with bipolar disorder and typically developing participants following alcohol administration. For instance, in some conditions, individuals with bipolar disorder reported higher mean subjective intoxication scores compared to the typically developing group. The statistical analyses, with p-values of 0.05 and 0.004, suggest these observed differences are statistically significant. These findings contribute to understanding the distinct acute alcohol responses in individuals with bipolar disorder, which may shed light on the mechanisms underlying the high comorbidity between bipolar disorder and alcohol use disorders.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04063384, titled "Acute Alcohol Response In Bipolar Disorder: a fMRI Study", were posted on 2025-11-19 on clinicaltrials.gov.