NCT05838274Recruiting
Acute Alcohol Response In Bipolar Disorder: a Longitudinal Alcohol Administration/fMRI Study
Biological Risk Factors for the Prospective Development of Alcohol Use Disorders in Young Adults With Bipolar Disorder and Typically Developing Young Adults
Source: ClinicalTrials.gov · Last updated 12 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 10 Apr 2023
- Start date
- 11 Jul 2023
- Primary completion date
- 31 Mar 2028
- Lead sponsor
- University of Texas at Austin
- Diseases
- Bipolar disorder
- NCT number
- NCT05838274
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 11 Jul 2023 to the primary completion date, 31 Mar 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- any prior psychiatric hospitalizations
- greater than 1 month of lifetime psychotropic medication.
Other illness
- history of significant medical illness, particularly if possible changes in cerebral tissue
- current cannabis use disorder\>moderate
- history of severe AUDs
- scores \> 15 on the alcohol Use Disorders Identification Test (AUDIT; part of phone screen)
- history of heart attack, heart trouble, high blood pressure, diabetes, or liver disease
- 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:
- lifetime history of a neurodevelopmental disorder, affective disorder, psychotic disorder, eating disorder
Other
- For all subjects exclusion criteria include:
- 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
- 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
- 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
Who the study is looking for
- 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
- \- Meeting Diagnostic and Statistical Manual-5 Research Version (DSM-V-RV) diagnostic criteria for bipolar disorder, confirmed by structured interview
Age in the registry: 21 years to 26 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Texas at Austin Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.