NCT04716036Completed

Familial Risk for Bipolar Disorder and Alcohol Sensitivity

Dissecting Responses to Alcohol in Individuals With Familial Risk for Bipolar Disorder

Source: ClinicalTrials.gov · Last updated 24 Jul 2024

Brief summary (registry, in English)

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 influence of alcohol compared to placebo session will also be investigated. Additionally, associations between objective and subjective responses to alcohol and drinking patterns will be explored (secondary outcome). The primary endpoint of the study will be after completion of both alcohol and placebo beverage conditions.

Status (registry): Completed
Study type: Interventional
Enrollment: 68 (actual)
First submitted: 12 Jan 2021
Start date: 13 May 2021
Primary completion date: 30 Apr 2024
Lead sponsor: University of Texas at Austin
Diseases: Bipolar disorder
NCT number: NCT04716036

What you commit to

Study type: Interventional
Participants enrolled: 68
From 13 May 2021 to the primary completion date, 30 Apr 2024
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 manic episode
history of psychosis
history of significant medical illness, particularly if possible changes in cerebral tissue
history of cannabis use disorder\>moderate over past year
history of AUD\>mild over lifetime
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 substance use disorder (other than alcohol, cannabis, or nicotine) over the past year
- Additional exclusion criteria for familial risk for bipolar disorder participants:
- \- not taking medications for \>4 weeks (i.e. participants must be stable on antidepressant or anti-anxiety medication)
- Additional exclusion criteria for healthy comparison subjects also include:
lifetime history of a neurodevelopmental disorder, affective disorder, psychotic disorder, eating disorder
having a parent diagnosed with a mood disorder or AUD

Other

For all subjects exclusion criteria include:
full Scale IQ \<85
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
a flushing response (possibly suggesting altered alcohol metabolism)
reporting never consuming 4 (men) or 3 (women) or more drinks on a single occasion at least twice 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 at least twice over the last year
euthymic at the time of study
\- having at least one parent diagnosed with bipolar disorder type I, confirmed by family history interview
having at least one parent diagnosed with bipolar disorder type I, confirmed by family history interview
having at least one parent diagnosed with an alcohol use disorder, confirmed by family history interview
\- having at least one parent diagnosed with an alcohol use disorder, confirmed by family history interview

Age in the registry: 21 years to 26 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

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	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.