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NCT05838274 · ClinicalTrials.gov registry record · NA
Acute Alcohol Response In Bipolar Disorder: a Longitudinal Alcohol Administration/fMRI Study
A NA study of Alcohol Use Disorder and Bipolar Disorder, sponsored by University of Texas at Austin.
- Recruiting
- Registry status
- NA
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT05838274 is a NA study of Alcohol Use Disorder and Bipolar Disorder that is actively recruiting participants, run by University of Texas at Austin. The registered enrollment target is 100 participants, below the 328-participant average among 184 other Alcohol Use Disorder trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05838274, a NA study of Alcohol Use Disorder and Bipolar Disorder, is actively recruiting participants, sponsored by University of Texas at Austin.
- RECRUITING
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study 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 st
Conditions Studied
Interventions
- OTHER Alcohol vs. Placebo beverage conditions
Study Locations (1)
Texas
- University of Texas at Austin - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2023-07-11 |
| Est. Completion | 2028-03-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05838274
The ClinicalTrials.gov registry entry for NCT05838274 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 328-participant average among 184 other Alcohol Use Disorder trials with a reported enrollment target (70% lower). The listed sponsor is University of Texas at Austin, which has 257 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Alcohol Use Disorder appearing as the primary indexed condition, and to 1 intervention - of which Alcohol vs. Placebo beverage conditions is the first listed.
NCT05838274 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT05838274 about?
NCT05838274 is a clinical study titled "Acute Alcohol Response In Bipolar Disorder: a Longitudinal Alcohol Administration/fMRI Study". 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...
What is the current status of trial NCT05838274?
This trial is currently recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2023-07-11. Estimated completion is 2028-03-31.
What conditions does trial NCT05838274 study?
This clinical trial studies the following conditions: Alcohol Use Disorder, Bipolar Disorder, Alcohol Drinking.
What interventions are being tested in trial NCT05838274?
The interventions under investigation include: Alcohol vs. Placebo beverage conditions (OTHER).
Who is sponsoring clinical trial NCT05838274?
This trial is sponsored by University of Texas at Austin, which has 257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05838274 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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