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Alcohol Sensitivity and Risk of Bipolar Disorder (FACS Trial)
N/A
Recruiting
Led By Elizabeth Lippard, PhD
Research Sponsored by University of Texas at Austin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
having at least one parent diagnosed with an alcohol use disorder, confirmed by family history interview
having at least one parent diagnosed with bipolar disorder type I, confirmed by family history interview
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 hours for alcohol session and up to 6 hours for placebo session
Awards & highlights
FACS Trial Summary
This trialaims to identify responses to alcohol in young adults at risk for bipolar disorder & AUDs, to inform novel interventions & improve outcomes.
Who is the study for?
This trial is for young adults aged 21-26 with no history of moderate or severe alcohol use disorders. Participants must have a parent diagnosed with bipolar disorder and/or an alcohol use disorder, confirmed by family history interview. They should be in a stable mood state at the time of study and not have any significant medical conditions or adverse reactions to alcohol.Check my eligibility
What is being tested?
The study tests how individuals with different familial risks for bipolar disorder and alcohol use disorders respond to actual alcohol versus placebo beverages. It involves wearing SCRAM sensors that measure transdermal alcohol concentration, while also monitoring heart rate, body sway, and subjective feelings of intoxication.See study design
What are the potential side effects?
Potential side effects from participating may include typical responses to alcoholic beverages such as changes in heart rate, dizziness (body sway), stimulation or sedation effects, anxiety relief (anxiolytic effects), and possibly mild intoxication symptoms.
FACS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
One of my parents has been diagnosed with an alcohol use disorder.
Select...
One of my parents has been diagnosed with bipolar disorder type I.
Select...
I am between 21 and 26 years old.
FACS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change (peak BrAC minus baseline BrAC) in behavior (self-report surveys) will be compared between alcohol and placebo sessions.
Ethanol
Change (peak BrAC minus baseline BrAC) in heart rate will be compared between alcohol and placebo sessions.
+4 moreSecondary outcome measures
Recent alcohol use patterns relations with variability in transdermal alcohol concentration: absorption and elimination rates
Alcohol Use Disorder
Recent alcohol use patterns relations with variability in transdermal alcohol concentration: peak TAC
+1 moreFACS Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: AlcoholActive Control1 Intervention
Participants will be dosed to a 0.08g% blood alcohol concentration.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive a low dose of alcohol (placebo condition).
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Who is running the clinical trial?
University of Texas at AustinLead Sponsor
353 Previous Clinical Trials
81,144 Total Patients Enrolled
5 Trials studying Bipolar Disorder
226 Patients Enrolled for Bipolar Disorder
Elizabeth Lippard, PhDPrincipal InvestigatorUniversity of Texas at Austin
3 Previous Clinical Trials
360 Total Patients Enrolled
2 Trials studying Bipolar Disorder
160 Patients Enrolled for Bipolar Disorder
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have tried to stop drinking alcohol but have been unable to do so.This study is looking for individuals who have a family history of both bipolar disorder and alcohol use disorders.We are looking for participants who have a family history of alcohol use disorders.You have struggled with addiction to drugs (excluding alcohol, cannabis, or nicotine) within the last year.You experience facial flushing when you drink alcohol, which may indicate a change in how your body processes alcohol.I have not had 4+ (men) or 3+ (women) drinks in one day more than once last year.One of my parents has been diagnosed with an alcohol use disorder.I have been on medication for mental health for over a month.I have a serious illness that could affect my brain.One of my parents has been diagnosed with bipolar disorder type I.You have had at least four drinks on one occasion (if you're a man) or three drinks (if you're a woman) at least twice in the past year.You have participated in a program that focuses on stopping alcohol use completely.I have been on stable medication for my mood for over 4 weeks.You have had a bad reaction to alcoholic drinks in the past.I do not have a family history of bipolar disorder.You have ever been diagnosed with a condition that affects the way your brain develops, your emotions, your thoughts, or your eating habits.I am at risk for bipolar disorder due to family history.You have personal or health reasons for not drinking alcohol, such as medical, religious, or other beliefs.I have had a manic episode in the past.My parent has been diagnosed with a mood disorder or alcohol use disorder.I am unwilling to arrange for someone to drive me home after alcohol sessions.I am between 21 and 26 years old.I have a history of heart issues, high blood pressure, diabetes, or liver disease.You have a history of experiencing severe mental health issues like hallucinations or delusions.You have had a significant problem with using cannabis (marijuana) too much in the past year.You have a history of alcohol use disorder that is more than mild and has lasted for a long time.
Research Study Groups:
This trial has the following groups:- Group 1: Alcohol
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are participating in this clinical investigation?
"Affirmative. According to information found on clinicaltrials.gov, this medical trial is actively searching for participants; it was initially posted on October 1st 2020 and has most recently been revised as of October 31st 2022. The study seeks one hundred patients across a single site."
Answered by AI
Who is eligible to partake in the experiment?
"This medical trial is seeking 100 patients with manic disorder who are between 21 and 26 years of age. Eligibility requirements must be met for individuals to qualify as suitable candidates."
Answered by AI
Are there any openings remaining in this experiment for participants?
"This research study is presently recruiting volunteers, as affirmed by the details on clinicaltrials.gov. It was initially advertised on October 1st 2020 and had its most recent edits made in late October 2022."
Answered by AI
What objectives is this trial attempting to achieve?
"The main objective of this clinical trial, which will last up to 6 hours for alcohol and a placebo session respectively, is to compare behavioral changes as evaluated through self-report surveys between the two sessions. Secondary goals include exploring correlations between recent drinking patterns (quantity) and transdermal alcohol concentration; peak TAC [(g/dL)], area under the curve ((g/dL) x minutes), absorption rate (peak TAC / time it took to rise from .000 - peak), elimination rate (peak Tac divided by time it took to decline from peak - .000)."
Answered by AI
Are elderly individuals eligible to join this experiment?
"Candidates for this research must be between 21 and 26 years old to qualify."
Answered by AI
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