- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05838274
Acute Alcohol Response In Bipolar Disorder: a Longitudinal Alcohol Administration/fMRI Study (Long_BACS)
Biological Risk Factors for the Prospective Development of Alcohol Use Disorders in Young Adults With Bipolar Disorder and Typically Developing Young Adults
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Research Coordinator
- Phone Number: 5124955198
- Email: behavioral.neuroimaging@austin.utexas.edu
Study Locations
-
-
Texas
-
Austin, Texas, United States, 78712
- Recruiting
- University of Texas at Austin
-
Contact:
- Research Coordinator
- Phone Number: 512-495-5198
- Email: behavioral.neuroimaging@austin.utexas.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Alcohol
Participants will be provided alcohol during study visits and changes in behavior/neural activity after consuming alcohol will be examined.
|
Individuals will drink beverages containing alcohol.
How they respond to a high vs. low dose will be compared.
|
Placebo Comparator: Placebo
placebo beverage condition
|
Individuals will drink beverages containing alcohol.
How they respond to a high vs. low dose will be compared.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
changes in subjective response
Time Frame: 2 years
|
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.
|
2 years
|
Neural trajectories associated with subjective response to alcohol
Time Frame: 2 years
|
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).
|
2 years
|
Relations between changes in subjective response and associated neural trajectories with alcohol use disorder symptoms at two-year follow-up
Time Frame: 2 years
|
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.
|
2 years
|
Relations between changes in subjective response and associated neural trajectories with alcohol misuse and problems at two-year follow-up
Time Frame: 2 years
|
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.
|
2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Elizabeth Lippard, PhD, University of Texas at Austin
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01AA030038 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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