RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Alcohol use disorders (AUDs) affect up to 60% of individuals with bipolar disorder during their lifetime and is associated with worse illness outcomes, yet few studies have been performed to clarify the causes of this comorbidity. Understanding biological risk factors that associate with and predict the development of AUDs in bipolar disorder could inform interventions and prevention efforts to reduce the rate of this comorbidity and improve outcomes of both disorders. Identifying predictors of risk requires longitudinal studies in bipolar disorder aimed at capturing the mechanisms leading to the emergence of AUDs. Previous work in AUDs suggest that subjective responses to alcohol and stress-related mechanisms may contribute to the development of AUDs. In bipolar disorder, altered developmental trajectory of critical ventral prefrontal networks that modulate mood and reward processing may alter responses to alcohol and stressors; consequently, the disruption in typical neurodevelopment may be an underlying factor for the high rates of comorbidity. No longitudinal data exist investigating if this developmental hypothesis is correct. To address this gap, the investigators will use a multimodal neuroimaging approach, modeling structural and functional neural trajectories of corticolimbic networks over young adulthood, incorporating alcohol administration procedures, clinical phenotyping, and investigating effects of acute stress exposure and early life stress. Research aims are to identify biological risk factors-i.e., changes in subjective response to alcohol and associated neural trajectories-that are associated with the development of alcohol misuse and symptoms of AUDs over a two-year longitudinal period in young adults with bipolar disorder and typical developing young adults. Longitudinal data will be collected on 160 young adults (50% with bipolar disorder, 50% female; aged 21-26). This study is a natural extension of the PI's K01 award. How acute exposure to stress and childhood maltreatment affects subjective response to alcohol and risk for prospective alcohol misuse and symptoms of AUDs will be investigated. The investigators will test our hypothesis that developmental differences in bipolar disorder versus typical developing individuals disrupt corticolimbic networks during young adulthood, increase sensitivity to stress, and lead to changes in subjective response to alcohol and placebo response increasing risk for developing AUDs.

Official Title

Biological Risk Factors for the Prospective Development of Alcohol Use Disorders in Young Adults With Bipolar Disorder and Typically Developing Young Adults

Quick Facts

Study Start:2023-07-11
Study Completion:2028-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05838274

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 26 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * between 21 and 26 years of age
  2. * having consumed at least 4 (men) or 3 (women) drinks on a single occasion over the last year
  3. * euthymic at the time of enrollment
  1. * history of significant medical illness, particularly if possible changes in cerebral tissue
  2. * neurologic abnormality including significant head trauma (loss of consciousness of ≥5-min)
  3. * full Scale intelligence quotient (IQ) \<85
  4. * contraindication to MRI scanning
  5. * positive pregnancy test
  6. * current cannabis use disorder\>moderate
  7. * history of severe AUDs
  8. * scores \> 15 on the alcohol Use Disorders Identification Test (AUDIT; part of phone screen)
  9. * ever being in an abstinence-oriented treatment program for alcohol use
  10. * reporting wanting to quit drinking but not being able to
  11. * any medical, religious, or other reasons for not drinking alcohol
  12. * history of heart attack, heart trouble, high blood pressure, diabetes, or liver disease
  13. * an adverse reaction to alcoholic beverages
  14. * reporting never consuming 4 (men) or 3 (women) or more drinks on a single occasion over the last year
  15. * unwillingness to have a friend or family member drive them home after the alcohol administration sessions
  16. * a past year substance use disorder (other than alcohol, cannabis, or nicotine)
  17. * any prior psychiatric hospitalizations
  18. * lifetime history of a neurodevelopmental disorder, affective disorder, psychotic disorder, eating disorder
  19. * greater than 1 month of lifetime psychotropic medication.

Contacts and Locations

Study Contact

Research Coordinator
CONTACT
5124955198
behavioral.neuroimaging@austin.utexas.edu

Principal Investigator

Elizabeth Lippard, PhD
PRINCIPAL_INVESTIGATOR
University of Texas at Austin

Study Locations (Sites)

University of Texas at Austin
Austin, Texas, 78712
United States

Collaborators and Investigators

Sponsor: University of Texas at Austin

  • Elizabeth Lippard, PhD, PRINCIPAL_INVESTIGATOR, University of Texas at Austin

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-11
Study Completion Date2028-03-31

Study Record Updates

Study Start Date2023-07-11
Study Completion Date2028-03-31

Terms related to this study

Additional Relevant MeSH Terms

  • Bipolar Disorder
  • Alcohol Drinking
  • Alcohol Use Disorder