Status:
COMPLETED
Acute Alcohol Response In Bipolar Disorder: a fMRI Study
Lead Sponsor:
University of Texas at Austin
Conditions:
Bipolar Disorder
Alcohol Drinking
Eligibility:
All Genders
21-26 years
Phase:
NA
Brief Summary
Alcohol use disorders (AUDs) affect up to 60% of individuals with bipolar disorder during their lifetime-a rate 3 to 5 times higher than what occurs in the general population. The mechanisms that cont...
Detailed Description
A total of 60 bipolar and healthy comparison subjects (n=30 per group, 21-26 years of age, 50% women, with no history of a moderate/severe AUD) will be recruited from the greater Austin area. Once rec...
Eligibility Criteria
Inclusion
- 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
- 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. -
Key Trial Info
Start Date :
July 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04063384
Start Date
July 22 2019
End Date
March 31 2024
Last Update
December 11 2025
Active Locations (1)
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1
University of Texas at Austin
Austin, Texas, United States, 78712