Acute Alcohol Response in Bipolar Disorder Study

This study is looking into how alcohol affects young adults (ages 21-26) with bipolar disorder, especially those who have had at least 4 (men) or 3 (women) drinks on one occasion in the past year. Researchers want to understand why alcohol use disorder (AUD) is common in people with bipolar disorder. You would drink beverages containing alcohol or a placebo (a drink with no alcohol) while researchers use fMRI (functional magnetic resonance imaging, a type of brain scan) to see how your brain responds. The study aims to see how your personal response to alcohol and brain activity change over two years, and if these changes are linked to symptoms of alcohol use disorder.

Study design
This interventional study plans to enroll 100 participants, with half having bipolar disorder. It compares responses to alcohol versus a placebo beverage.
What's involved
You would complete baseline clinical assessments, MRI scans, and sessions where you drink alcohol or a placebo. You would also have follow-up assessments, including clinical evaluations, detailed alcohol use assessments, and MRI scans, at approximately one and two years after joining.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for approximately two years after enrollment, with assessments at one and two years.

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NCT05838274

Acute Alcohol Response In Bipolar Disorder: a Longitudinal Alcohol Administration/fMRI Study

Recruiting
NAAges 21–26InterventionalPrevention
University of Texas at Austin
~100 participants
Updated 2026-01-12 on ClinicalTrials.gov
What's tested:Alcohol vs. Placebo beverage conditions

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
changes in subjective response
Measured over 2 years
+3 more outcomes measured
Bipolar Disorder
Alcohol Drinking
Alcohol Use Disorder
1 sites across 1 states
Texas1
  • Elizabeth Lippard, PhD · PRINCIPAL_INVESTIGATOR · University of Texas at Austin

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Eligibility criteria

Inclusion

between 21 and 26 years of age
having consumed at least 4 (men) or 3 (women) drinks on a single occasion over the last year
euthymic at the time of enrollment

Exclusion

history of significant medical illness, particularly if possible changes in cerebral tissue
neurologic abnormality including significant head trauma (loss of consciousness of ≥5-min)
full Scale intelligence quotient (IQ) \<85
contraindication to MRI scanning
positive pregnancy test
current cannabis use disorder\>moderate
history of severe AUDs
scores \> 15 on the alcohol Use Disorders Identification Test (AUDIT; part of phone screen)
ever being in an abstinence-oriented treatment program for alcohol use
reporting wanting to quit drinking but not being able to
any medical, religious, or other reasons for not drinking alcohol
history of heart attack, heart trouble, high blood pressure, diabetes, or liver disease
an adverse reaction to alcoholic beverages
reporting never consuming 4 (men) or 3 (women) or more drinks on a single occasion over the last year
unwillingness to have a friend or family member drive them home after the alcohol administration sessions
a past year substance use disorder (other than alcohol, cannabis, or nicotine)
any prior psychiatric hospitalizations
lifetime history of a neurodevelopmental disorder, affective disorder, psychotic disorder, eating disorder
greater than 1 month of lifetime psychotropic medication.
  • changes in subjective response2 years

    Subjective response to alcohol will be measured with the subjective effects of alcohol scale (SEAS) at baseline and two-years later and changes in subjective response to alcohol over time (SEAS two year follow-up minus SEAS baseline) investigated and interactions with group (young adults with bipolar disorder, typical comparison young adults) modeled.

  • Neural trajectories associated with subjective response to alcohol2 years

    Changes in neural trajectories over the two-year follow-up period will be modeled and relations with subjective response at two-year follow-up investigated. We will model changes in cortical thickness and surface area of frontolimbic regions of interest and investigate if these neural trajectories relate to changes in subjective response to alcohol (measured with the SEAS at baseline and follow-up).

  • Relations between changes in subjective response and associated neural trajectories with alcohol use disorder symptoms at two-year follow-up2 years

    Changes in subjective response (measured with the SEAS) and neural trajectories over the follow up period (changes in cortical thickness and surface area of frontlimbic regions of interest) and relations with alcohol problems at two-year follow up will be modeled with number of alcohol use disorder symptoms on the SCID at two-year follow up as the dependent variable.

  • Relations between changes in subjective response and associated neural trajectories with alcohol misuse and problems at two-year follow-up2 years

    Changes in subjective response (measured with the SEAS) and neural trajectories over the follow up period (changes in cortical thickness and surface area of frontolimbic regions of interest) and relations with alcohol problems at two-year follow up will be modeled with AUDIT score at two-year follow up as the dependent variable.