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

Primary Purpose

Bipolar Disorder, Alcohol Drinking, Alcohol Use Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Alcohol vs. Placebo beverage conditions
Sponsored by
University of Texas at Austin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bipolar Disorder

Eligibility Criteria

21 Years - 26 Years (Adult)All SexesAccepts Healthy Volunteers

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 study 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.

Sites / Locations

  • University of Texas at AustinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Alcohol

Placebo

Arm Description

Participants will be provided alcohol during study visits and changes in behavior/neural activity after consuming alcohol will be examined.

placebo beverage condition

Outcomes

Primary Outcome Measures

changes in subjective response
Subjective response to alcohol will be measured with the subjective effects of alcohol scale (SEAS) at baseline and two-years later and changes in subjective response to alcohol over time (SEAS two year follow-up minus SEAS baseline) investigated and interactions with group (young adults with bipolar disorder, typical comparison young adults) modeled.
Neural trajectories associated with subjective response to alcohol
Changes in neural trajectories over the two-year follow-up period will be modeled and relations with subjective response at two-year follow-up investigated. We will model changes in cortical thickness and surface area of frontolimbic regions of interest and investigate if these neural trajectories relate to changes in subjective response to alcohol (measured with the SEAS at baseline and follow-up).
Relations between changes in subjective response and associated neural trajectories with alcohol use disorder symptoms at two-year follow-up
Changes in subjective response (measured with the SEAS) and neural trajectories over the follow up period (changes in cortical thickness and surface area of frontlimbic regions of interest) and relations with alcohol problems at two-year follow up will be modeled with number of alcohol use disorder symptoms on the SCID at two-year follow up as the dependent variable.
Relations between changes in subjective response and associated neural trajectories with alcohol misuse and problems at two-year follow-up
Changes in subjective response (measured with the SEAS) and neural trajectories over the follow up period (changes in cortical thickness and surface area of frontolimbic regions of interest) and relations with alcohol problems at two-year follow up will be modeled with AUDIT score at two-year follow up as the dependent variable.

Secondary Outcome Measures

Full Information

First Posted
April 10, 2023
Last Updated
June 7, 2023
Sponsor
University of Texas at Austin
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1. Study Identification

Unique Protocol Identification Number
NCT05838274
Brief Title
Acute Alcohol Response In Bipolar Disorder: a Longitudinal Alcohol Administration/fMRI Study
Acronym
Long_BACS
Official Title
Biological Risk Factors for the Prospective Development of Alcohol Use Disorders in Young Adults With Bipolar Disorder and Typically Developing Young Adults
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
March 31, 2028 (Anticipated)
Study Completion Date
March 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas at Austin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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-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.
Detailed Description
The PI is currently investigating subjective response to alcohol in bipolar disorder and typical developing young adults (n=60; 50% with bipolar disorder) using placebo-controlled alcohol administration with baseline structural/functional 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 PI's 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 role(s) 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 PI's K01 will be brought back for longitudinal assessments to reach N=80 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; n=40 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder, Alcohol Drinking, Alcohol Use Disorder

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Alcohol
Arm Type
Active Comparator
Arm Description
Participants will be provided alcohol during study visits and changes in behavior/neural activity after consuming alcohol will be examined.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo beverage condition
Intervention Type
Other
Intervention Name(s)
Alcohol vs. Placebo beverage conditions
Intervention Description
Individuals will drink beverages containing alcohol. How they respond to a high vs. low dose will be compared.
Primary Outcome Measure Information:
Title
changes in subjective response
Description
Subjective response to alcohol will be measured with the subjective effects of alcohol scale (SEAS) at baseline and two-years later and changes in subjective response to alcohol over time (SEAS two year follow-up minus SEAS baseline) investigated and interactions with group (young adults with bipolar disorder, typical comparison young adults) modeled.
Time Frame
2 years
Title
Neural trajectories associated with subjective response to alcohol
Description
Changes in neural trajectories over the two-year follow-up period will be modeled and relations with subjective response at two-year follow-up investigated. We will model changes in cortical thickness and surface area of frontolimbic regions of interest and investigate if these neural trajectories relate to changes in subjective response to alcohol (measured with the SEAS at baseline and follow-up).
Time Frame
2 years
Title
Relations between changes in subjective response and associated neural trajectories with alcohol use disorder symptoms at two-year follow-up
Description
Changes in subjective response (measured with the SEAS) and neural trajectories over the follow up period (changes in cortical thickness and surface area of frontlimbic regions of interest) and relations with alcohol problems at two-year follow up will be modeled with number of alcohol use disorder symptoms on the SCID at two-year follow up as the dependent variable.
Time Frame
2 years
Title
Relations between changes in subjective response and associated neural trajectories with alcohol misuse and problems at two-year follow-up
Description
Changes in subjective response (measured with the SEAS) and neural trajectories over the follow up period (changes in cortical thickness and surface area of frontolimbic regions of interest) and relations with alcohol problems at two-year follow up will be modeled with AUDIT score at two-year follow up as the dependent variable.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 study 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Research Coordinator
Phone
5124955198
Email
behavioral.neuroimaging@austin.utexas.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Lippard, PhD
Organizational Affiliation
University of Texas at Austin
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas at Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
512-495-5198
Email
behavioral.neuroimaging@austin.utexas.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
After study completion and publication of finding, functional neuroimaging data and behavior data collected following alcohol and placebo conditions will be shared.
IPD Sharing Time Frame
We will complete all our analyses and publish results and methodologies in scientific journals before the data are available to the research community. Data will be made available following 6 months after publication.
IPD Sharing Access Criteria
We will be collecting identifying information. Even though the final dataset will be stripped of identifiers prior to release for sharing, we believe that there remains the possibility of deductive disclosure of subjects with unusual characteristics. Thus, we will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.

Learn more about this trial

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

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