Status:
COMPLETED
Familial Risk for Bipolar Disorder and Alcohol Sensitivity
Lead Sponsor:
University of Texas at Austin
Conditions:
Bipolar Disorder
Alcohol Drinking
Eligibility:
All Genders
21-26 years
Phase:
NA
Brief Summary
Early identification in individuals with bipolar disorder who are at risk for AUDs could inform novel intervention strategies and improve life-long outcomes. The primary objective of this protocol is ...
Detailed Description
A total of 100 young adults (21-26 years; 50% women, no history of AUDs\>mild) will be recruited from the greater Austin area. Participants will be equally divided among those with parental history of...
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 at least twice over the last year
- euthymic at the time of study
- Inclusion criteria for familial risk for bipolar disorder (only) participants:
- \- having at least one parent diagnosed with bipolar disorder type I, confirmed by family history interview
- Inclusion criteria for familial risk for both bipolar disorder and alcohol use disorders participants:
- having at least one parent diagnosed with bipolar disorder type I, confirmed by family history interview
- having at least one parent diagnosed with an alcohol use disorder, confirmed by family history interview
- Inclusion criteria for familial risk for alcohol use disorders (only) participants:
- \- having at least one parent diagnosed with an alcohol use disorder, confirmed by family history interview
Exclusion
- For all subjects exclusion criteria include:
- history of manic episode
- history of psychosis
- history of significant medical illness, particularly if possible changes in cerebral tissue
- full Scale IQ \<85
- positive pregnancy test
- history of cannabis use disorder\>moderate over past year
- history of AUD\>mild over lifetime
- 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
- a flushing response (possibly suggesting altered alcohol metabolism)
- reporting never consuming 4 (men) or 3 (women) or more drinks on a single occasion at least twice over the last year
- unwillingness to have a friend or family member drive them home after the alcohol administration sessions
- a past substance use disorder (other than alcohol, cannabis, or nicotine) over the past year
- Additional exclusion criteria for familial risk for bipolar disorder participants:
- \- not taking medications for \>4 weeks (i.e. participants must be stable on antidepressant or anti-anxiety medication)
- 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
- having a parent diagnosed with a mood disorder or AUD
- greater than 1 month of lifetime psychotropic medication
Key Trial Info
Start Date :
May 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2024
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT04716036
Start Date
May 13 2021
End Date
April 30 2024
Last Update
July 24 2024
Active Locations (1)
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1
University of Texas at Austin
Austin, Texas, United States, 78712