Actively Recruiting
Biological Risk Factors for Development of Alcohol Use Disorders in Young Adults With Bipolar Disorder and Typical Development
Led by University of Texas at Austin · Updated on 2026-01-12
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating biological risk factors that contribute to alcohol use disorders (AUDs) in young adults with bipolar disorder compared to typically developing young adults. This study aims to understand how changes in brain networks and subjective responses to alcohol and stress may predict the development of AUDs over two years. The study focuses on individuals aged 21 to 26, tracking how stress exposure and early life experiences influence alcohol use and symptoms in these groups. Participants will undergo alcohol administration sessions where they consume beverages containing alcohol or placebo to study their behavioral and neural responses. Initial assessments include clinical evaluations, MRI scans, and placebo-controlled alcohol sessions. Follow-up occurs at one and two years, repeating clinical and MRI assessments, with some participants completing additional stress-related brain imaging and alcohol response tests. This approach allows researchers to examine changes in sensitivity to alcohol and brain function over time in relation to AUD symptoms. Throughout the study, participants will be evaluated using clinical interviews, neuroimaging, and detailed alcohol use assessments. Researchers will monitor changes in subjective alcohol response, neural brain network trajectories, and the impact of stress. Outcomes focus on how these factors relate to alcohol misuse and AUD symptoms after two years. Safety measures include monitoring alcohol intake and ensuring participants have safe transportation after sessions. The total study duration for participants is approximately two years with multiple visits for testing and follow-up.
CONDITIONS
Brief Title
Acute Alcohol Response In Bipolar Disorder: a Longitudinal Alcohol Administration/fMRI Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between 21 and 26 years of age
- Consumed at least 4 (men) or 3 (women) drinks on a single occasion in the last year
- Euthymic (stable mood) at the time of enrollment
- For bipolar disorder group: diagnosed with bipolar disorder confirmed by structured interview
You will not qualify if you...
- History of significant medical illness affecting brain tissue
- Neurologic abnormalities including head trauma with loss of consciousness over 5 minutes
- Full scale IQ below 85
- Contraindications to MRI
- Positive pregnancy test
- Current moderate or greater cannabis use disorder
- History of severe alcohol use disorders
- Alcohol Use Disorders Identification Test (AUDIT) score over 15
- Previous participation in abstinence-oriented alcohol treatment
- Desire to quit drinking but inability to do so
- Medical, religious, or other reasons for not drinking alcohol
- History of heart attack, heart trouble, high blood pressure, diabetes, or liver disease
- Adverse reaction to alcoholic beverages
- Never consumed 4 (men) or 3 (women) or more drinks on a single occasion in the last year
- Unwillingness to have a friend or family member drive after alcohol sessions
- Past year substance use disorder (other than alcohol, cannabis, or nicotine)
- For bipolar group: not stable on medications for at least 4 weeks
- For healthy group: any prior psychiatric hospitalizations, lifetime history of neurodevelopmental, affective, psychotic, or eating disorders
- More than 1 month lifetime use of psychotropic medication
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single visit period
Participants complete baseline clinical assessments, MRI scans, and placebo-controlled alcohol administration sessions to evaluate subjective and neural responses to alcohol.
1 to 2 visits including MRI and alcohol/placebo sessions
Duration - Over several days at one year after enrollment
A subset of participants complete psychosocial stress and neutral fMRI tasks on separate days followed immediately by alcohol sessions to assess stress-induced changes.
2 to 3 visits depending on tasks
Duration - Single visit period at two years after enrollment
Participants return for repeat placebo-controlled alcohol administration sessions and MRI assessments to examine changes in alcohol sensitivity and neural trajectories over time.
1 to 2 visits including MRI and alcohol/placebo sessions
Trial Site Locations
Total: 1 location
1
University of Texas at Austin
Austin, Texas, United States, 78712
Actively Recruiting
Research Team
R
Research Coordinator
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
PREVENTION
Number of Arms
2
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