Understanding how alcohol affects young adults with bipolar disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the subjective and neural responses to alcohol in young adults with bipolar disorder compared to their typically developing peers. It involves a placebo-controlled alcohol administration and MRI assessments to explore how these responses change over time and their relationship with alcohol use and symptoms. The study aims to identify biological risk factors that may predict the development of alcohol use disorders in individuals with bipolar disorder, utilizing a longitudinal approach over two years. Participants will undergo clinical assessments and MRI scans at baseline and follow-ups to track changes in sensitivity to alcohol and associated neural changes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Inclusion criteria for all participants:

* 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

Inclusion criteria for bipolar disorder participants:

\- Meeting Diagnostic and Statistical Manual-5 Research Version (DSM-V-RV) diagnostic criteria for bipolar disorder, confirmed by structured interview

Exclusion Criteria:

For all subjects exclusion criteria include:

* 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)

Additional exclusion criteria for bipolar disorder participants:

\- not taking medications for greater than or equal to 4 weeks (i.e. participants must be stable on medications)

Additional exclusion criteria for healthy comparison subjects also include:

* any prior psychiatric hospitalizations
* lifetime history of a neurodevelopmental disorder, affective disorder, psychotic disorder, eating disorder
* greater than 1 month of lifetime psychotropic medication.

Where it's running

• University of Texas at Austin
  Austin, Texas, United States Recruiting

Study contacts

• Principal investigator: Elizabeth Lippard, PhD — University of Texas at Austin
• Study coordinator: Research Coordinator
• Email: behavioral.neuroimaging@austin.utexas.edu
• Phone: 5124955198

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.