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Search / Trial NCT05838274

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

Launched by UNIVERSITY OF TEXAS AT AUSTIN · Apr 20, 2023

Trial Information

Current as of August 22, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying how alcohol affects individuals with bipolar disorder and aims to understand why many people with this condition may also develop problems with alcohol use. The researchers want to learn about the biological factors that contribute to this link, especially focusing on how stress and early life experiences might change the way people respond to alcohol. They will follow the experiences of 160 young adults over two years, half of whom will have bipolar disorder and half who are typically developing, to see how their brains respond to alcohol and stress.

To participate in this study, individuals need to be between 21 and 26 years old and have consumed a certain amount of alcohol in the past year. For those with bipolar disorder, they must meet specific diagnostic criteria confirmed by an interview. Participants will undergo brain scans and alcohol administration sessions, during which they will be monitored for their reactions. It's important to note that participants should not have serious medical conditions or a history of substance use disorders that could affect their eligibility. If you or someone you know fits this description and is interested in contributing to this important research, this study could provide valuable insights into the relationship between bipolar disorder and alcohol use.

Gender

ALL

Eligibility criteria

  • 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.

About University Of Texas At Austin

The University of Texas at Austin, a leading research institution, is dedicated to advancing knowledge and innovation in the field of healthcare through rigorous clinical trials. Known for its commitment to scientific excellence, the university leverages its diverse expertise and cutting-edge facilities to conduct research that addresses critical health challenges. Collaborating with a multidisciplinary team of researchers, clinicians, and students, the University of Texas at Austin aims to translate scientific discoveries into effective treatments and interventions, ultimately enhancing patient outcomes and contributing to the advancement of medical science.

Locations

Austin, Texas, United States

Patients applied

MW

JG

2 patients applied

Trial Officials

Elizabeth Lippard, PhD

Principal Investigator

University of Texas at Austin

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported