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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

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.
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.
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 more

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

Find a Location

Who is running the clinical trial?

University of Texas at AustinLead Sponsor
375 Previous Clinical Trials
86,195 Total Patients Enrolled
5 Trials studying Bipolar Disorder
194 Patients Enrolled for Bipolar Disorder
Elizabeth Lippard, PhDPrincipal InvestigatorUniversity of Texas at Austin
3 Previous Clinical Trials
328 Total Patients Enrolled
2 Trials studying Bipolar Disorder
128 Patients Enrolled for Bipolar Disorder

Media Library

Alcohol vs. Placebo beverage conditions Clinical Trial Eligibility Overview. Trial Name: NCT05838274 — N/A
Bipolar Disorder Research Study Groups: Placebo, Alcohol
Bipolar Disorder Clinical Trial 2023: Alcohol vs. Placebo beverage conditions Highlights & Side Effects. Trial Name: NCT05838274 — N/A
Alcohol vs. Placebo beverage conditions 2023 Treatment Timeline for Medical Study. Trial Name: NCT05838274 — N/A
~67 spots leftby Mar 2028
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