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NCT04063384 · ClinicalTrials.gov registry record · NA
Acute Alcohol Response In Bipolar Disorder: a fMRI Study
A NA study of Alcohol Use Disorder and Bipolar Disorder, sponsored by University of Texas at Austin.
- Completed
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT04063384 is a NA study of Alcohol Use Disorder and Bipolar Disorder that has completed, run by University of Texas at Austin. The registered enrollment target is 60 participants, below the 328-participant average among 184 other Alcohol Use Disorder trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04063384, a NA study of Alcohol Use Disorder and Bipolar Disorder, has completed, sponsored by University of Texas at Austin.
- COMPLETED
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study 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 contribute to elevated rates of comorbidity are not known. 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 to use alcohol administration procedures and functional MRI techniques to investigate subjective response to alcohol, compared to placebo, and relationship with functional responses of, and connectivity among, brain regions in ventral prefrontal emotional networks in young adults with bipolar disorder and healthy comparison young adults. Baseline clinical and structural MRI assessments will be completed in 30 bipolar and 30 healthy young adults (21-26 years of age, 50% women). Then, following standard beverage administration procedures, participants will complete within-person, counter-balanced, fMRI scans and complete measures of subjective response to alcohol while under the influence of alcohol or placebo. Specifically, individual differences in the experience of stimulating, sedative, and anxiolytic effects of alcohol (measured with self-report surveys) and individual differences in neural responses to alcohol within ventral prefrontal emotional networks will be investigated and differences in bipolar disorder compared to healthy participants assessed. Functional MRI scans during a continuous performance task with emotional and neutral distractors (CPT-END) and at rest will be collected while under the influence of alcohol and placebo and compared. Experience of stimulating, sedative, and anxiolytic effects of alcohol from self-report survey data and neural responses to emotional stimuli while under the influence of alcohol compared to placebo will be the primary data outcomes assessed. Additionally, associations be
Conditions Studied
Interventions
- OTHER alcohol beverage
- OTHER Placebo beverage
Study Locations (1)
Texas
- University of Texas at Austin - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2019-07-22 |
| Est. Completion | 2024-03-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04063384
The ClinicalTrials.gov registry entry for NCT04063384 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 60 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 (82% 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 2 interventions - of which alcohol beverage is the first listed.
NCT04063384 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT04063384 about?
NCT04063384 is a clinical study titled "Acute Alcohol Response In Bipolar Disorder: a fMRI Study". 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 contribute to elevated rates of comorbidity are not known. Early identification in individuals with bipo...
What is the current status of trial NCT04063384?
This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2019-07-22. Estimated completion is 2024-03-31.
What conditions does trial NCT04063384 study?
This clinical trial studies the following conditions: Alcohol Use Disorder, Bipolar Disorder, Alcohol Drinking.
What interventions are being tested in trial NCT04063384?
The interventions under investigation include: alcohol beverage (OTHER), Placebo beverage (OTHER).
Who is sponsoring clinical trial NCT04063384?
This trial is sponsored by University of Texas at Austin, which has 257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04063384 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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Read our methodology - how this data is sourced, computed, and verified.
Related
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