Ignite Creation Date:
2024-05-06 @ 6:56 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05838274
Status:
RECRUITING
Last Update Posted:
2023-12-26
First Post:
2023-04-10
Brief Title:
Acute Alcohol Response In Bipolar Disorder a Longitudinal Alcohol AdministrationfMRI Study
Sponsor:
University of Texas at Austin
Organization:
University of Texas at Austin
Study Overview
Official Title:
Biological Risk Factors for the Prospective Development of Alcohol Use Disorders in Young Adults With Bipolar Disorder and Typically Developing Young Adults
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Long_BACS
Brief Summary:
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-ie 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 PIs 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
Detailed Description:
The PI is currently investigating subjective response to alcohol in bipolar disorder and typical developing young adults n60 50 with bipolar disorder using placebo-controlled alcohol administration with baseline structuralfunctional MRI assessments collected with her K01 The proposed work will extend this active study to enroll 100 new young adults 50 with bipolar disorder to complete baseline clinical MRI and placebo-controlled alcohol administration sessions The PIs K01 is focused on investigating differences in subjective and neural response to alcohol between bipolar disorder and typical developing young adults The proposed study will focus on investigating changes in subjective response to alcohol placebo response and relations with neural trajectories the roles of stress and prediction of alcohol problems over a two-year period Longitudinal follow-up clinical detailed assessment of alcohol use and MRI will occur on average 1- and 2-years following enrollment Participants enrolled on the PIs K01 will be brought back for longitudinal assessments to reach N80 per group with longitudinal data 50 female aged 21-26 At 2-year follow-up placebo-controlled alcohol administration sessions will be repeated to test if sensitivity to alcohol changes over time-and if change in sensitivity to alcohol is associated with progressive neural changes in corticolimbic brain networks during young adulthood-and associations with alcohol use and symptoms of AUDs over time and interactions with bipolar disorder Changes in placebo-response and if changes are predictive of increased alcohol use and symptoms of AUDs will also be modeled At one-year follow-up a subset of participants will be invited to complete a psychosocial stress and neutral fMRI task on separate days counter balanced n40 per group Participants will immediately complete an alcohol session following the fMRI tasks and stress-induced changes in subjective response to alcohol and interactions with group will be modeled
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None