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Alcohol Response for Bipolar Disorder (Long_BACS 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
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Long_BACS Trial Summary
This trial will look at how stress, childhood maltreatment, and brain development affect the risk of developing alcohol use disorders in people with bipolar disorder. It will involve 160 people, half with bipolar disorder, and study their brain development and response to alcohol over two years.
Who is the study for?
This study is for young adults aged 21-26, both with bipolar disorder and typical development. Participants must have had a certain level of alcohol use in the past year but not severe alcohol use disorders or other significant medical conditions. They should be stable on medications if any, and able to undergo MRI scans.Check my eligibility
What is being tested?
The trial investigates how individuals with bipolar disorder respond to alcohol compared to a placebo beverage. It aims to understand biological risk factors for developing alcohol misuse by using neuroimaging techniques over two years.See study design
What are the potential side effects?
While the study involves consuming alcohol, potential side effects are not detailed; however, common reactions may include impaired judgment, coordination issues, mood changes, and hangover symptoms like headache or nausea.
Long_BACS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Neural trajectories associated with subjective response to alcohol
Relations between changes in subjective response and associated neural trajectories with alcohol misuse and problems at two-year follow-up
Relations between changes in subjective response and associated neural trajectories with alcohol use disorder symptoms at two-year follow-up
+1 moreLong_BACS Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: AlcoholActive Control1 Intervention
Participants will be provided alcohol during study visits and changes in behavior/neural activity after consuming alcohol will be examined.
Group II: PlaceboPlacebo Group1 Intervention
placebo beverage 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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of heart issues, high blood pressure, diabetes, or liver disease.I have had a significant head injury with unconsciousness for 5 minutes or more.I have never been hospitalized for psychiatric reasons.I have taken psychotropic medication for no more than 1 month in my life.I am unwilling to arrange for someone to drive me home after alcohol sessions.I have been on stable medication for my bipolar disorder for at least 4 weeks.I have not had more than 3 (if woman) or 4 (if man) drinks in one day in the past year.I am between 21 and 26 years old.I have never been diagnosed with a neurodevelopmental, mood, psychotic, or eating disorder.I have been diagnosed with bipolar disorder by a structured interview.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Alcohol
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.
What is the size of the cohort under scrutiny in this research endeavor?
"Affirmative. According to clinicaltrials.gov, this medical study was established on June 1st 2023 and is currently in the process of recruitment. One hundred individuals are needed from a single site for successful completion of the trial."
Answered by AI
What criteria would make a person qualified to join this clinical experiment?
"The prerequisites of this trial dictate that applicants must be between 21 and 26 years old with a diagnosis of bipolar disorder. This study seeks to enrol approximately 100 participants."
Answered by AI
Are individuals below the age of forty eligible to join this trial?
"Eligibility for this experiment is restricted to the age bracket of 21-26. Separately, there are 304 trials available for minors and 928 studies available for elderly patients."
Answered by AI
Are any new participants being sought for this experiment?
"Clinicaltrials.gov reveals that this clinical trial is actively enrolling patients, with the initial post being made on June 1st 2023 and updated on July 6th of the same year."
Answered by AI
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