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NCT04716036 · ClinicalTrials.gov registry record · NA
Familial Risk for Bipolar Disorder and Alcohol Sensitivity
A NA study, sponsored by University of Texas at Austin.
- Completed
- Registry status
- NA
- Development phase
- 68
- Enrollment target
NCT04716036 is a NA study that has completed, run by University of Texas at Austin. The registered enrollment target is 68 participants.
The verdict
NCT04716036, a NA study, has completed, sponsored by University of Texas at Austin.
- COMPLETED
- Registry status
- NA
- Development phase
- 68 participants
- Enrollment target
Study 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 to use alcohol administration procedures and alcohol biosensor technology to investigate responses to alcohol, compared to placebo, and relationship with parental risk for alcohol use disorders and/or bipolar disorder in young adults. Baseline clinical, cognitive, and behavioral assessments will be completed in 100 young adults (21-26 years; 50% women, no history of AUDs\>mild). Participants would be equally divided among those with parental history of bipolar disorder but not AUDs, parental history of bipolar disorder and AUDs, parental history of AUDs but not bipolar disorder, and typically developing age- and sex-matched controls with no parental history of mood disorders or AUDs (N=25 per group). Then, while wearing Secure Continuous Remote Alcohol Monitoring \[SCRAM\] sensors, participants will complete within-person, counter-balanced, beverage sessions (following standard beverage administration procedures) in a simulated bar laboratory. Changes in heart rate, body sway and subjective self-report measurements of intoxication will also be completed while under the influence of alcohol or placebo. Specifically, individual differences in transdermal alcohol concentration (the primary data output from SCRAM sensors), physiological changes (e.g. heart rate), and the experience of stimulating, sedative, and anxiolytic effects of alcohol (measured with self-report surveys) will be investigated and differences between parental risk subgroups and healthy comparison participants investigated. Differences in transdermal alcohol concentration collected while under the influence of alcohol will be the primary data outcome assessed. Changes in heart rate, body sway, and experience of stimulating, sedative, and anxiolytic effects (from self-report survey data) while under the in
Interventions
- OTHER Alcohol beverage
- OTHER Placebo beverage
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2021-05-13 |
| Est. Completion | 2024-04-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04716036
The ClinicalTrials.gov registry entry for NCT04716036 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 68 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Texas at Austin, which has 257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Alcohol beverage is the first listed.
NCT04716036 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04716036 about?
NCT04716036 is a clinical study titled "Familial Risk for Bipolar Disorder and Alcohol Sensitivity". 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 alcohol biosensor technology to investigate responses t...
What is the current status of trial NCT04716036?
This trial is currently completed. It is a NA study. The enrollment target is 68 participants. The study started on 2021-05-13. Estimated completion is 2024-04-30.
What interventions are being tested in trial NCT04716036?
The interventions under investigation include: Alcohol beverage (OTHER), Placebo beverage (OTHER).
Who is sponsoring clinical trial NCT04716036?
This trial is sponsored by University of Texas at Austin, which has 257 total clinical trials registered on ClinicalTrials.gov.
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