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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: Completed NA study, sponsored by University of Texas at Austin.

NCT04716036 is a NA study that has completed, run by University of Texas at Austin. The registered enrollment target is 68 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

Changes in transdermal alcohol concentration (TAC) during the alcohol session (i.e. time to reach peak TAC \[measured in minutes\]) will be compared between subgroups. Study participation to collect data (baseline clinical assessment, alcohol and placebo beverage sessions) should not take more than 13 hours. Participants will wear SCRAM sensors overnight following their alcohol session and return the following morning for SCRAM sensor removal (which takes \<15 minutes).

Interventions

  • OTHER Alcohol beverage
  • OTHER Placebo beverage

Trial Details

FieldValue
Enrollment Target 68 participants
Start Date 2021-05-13
Est. Completion 2024-04-30
Phase NA
University of Texas at Austin

257 total trials

What the finished NCT04716036 record still lists

NCT04716036 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 2 interventions - of which Alcohol beverage is the first listed.

NCT04716036 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT04716036's enrollment target sits among peer trials

68 1133rd of 2000 higher than 862 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04716036, the US trial registry maintained by the National Library of Medicine. NCT04716036 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.