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Alcohol Response in Bipolar Disorder (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

between 21 and 26 years of age

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 months

Awards & highlights

BACS Trial Summary

This trial is investigating whether alcohol use affects people with bipolar disorder differently than those without the disorder, and whether this difference is reflected in brain activity.

Who is the study for?

This study is for young adults aged 21-26 who have bipolar disorder and drink alcohol but don't have severe alcohol use disorders or other major health issues. They must be stable, not pregnant, and able to consume alcohol without adverse effects.Check my eligibility

What is being tested?

The trial tests how a person with bipolar disorder responds to an alcoholic beverage versus a placebo. It uses fMRI scans to observe brain activity related to emotional responses while under the influence of both substances.See study design

What are the potential side effects?

Since this trial involves consuming alcohol, potential side effects include typical reactions such as dizziness, nausea, mood changes, and impaired coordination. The fMRI procedure itself is non-invasive with minimal risks.

BACS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 21 and 26 years old.

BACS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in behavior (self-report surveys: alcohol session minus placebo session)

Change in neural responses to emotional stimuli (fMRI: neural responses during alcohol session minus neural responses during placebo session)

Secondary outcome measures

Drinking patterns

BACS 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).

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Texas at AustinLead Sponsor

350 Previous Clinical Trials

80,924 Total Patients Enrolled

Elizabeth Lippard, PhDPrincipal InvestigatorUniversity of Texas at Austin

3 Previous Clinical Trials

400 Total Patients Enrolled

Media Library

alcohol beverage (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04063384 — N/A

Alcohol Consumption Research Study Groups: Alcohol, Placebo

Alcohol Consumption Clinical Trial 2023: alcohol beverage Highlights & Side Effects. Trial Name: NCT04063384 — N/A

alcohol beverage (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04063384 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical trial accept individuals below the age of fifty-five?

"Eligibility for this medical trial is limited to individuals aged 21 - 26 years old. For patients younger than 18, there are 287 relevant studies available and 878 appropriate trials exist for those above the age of 65."

Answered by AI

Is it possible to become a participant in this clinical research?

"This clinical trial is targeting 60 young adults aged 21 - 26 with a confirmed diagnosis of manic disorder. Furthermore, to be considered for enrollment, participants must have consumed at least 4 beverages (for men) or 3 drinks (for women) on a single occasion in the past year and currently exhibit euthymic state."

Answered by AI

Are there open positions for volunteers in this research trial?

"According to information on clinicaltrials.gov, this trial is actively looking for participants at the current moment in time. Initially posted on July 22nd 2019 and last updated January 5th 2022, potential candidates are highly desired."

Answered by AI

Can you approximate the number of participants currently receiving treatment through this clinical trial?

"Affirmative. Per clinicaltrials.gov, the study was initially posted on July 22nd 2019 and last modified January 5th 2022; now, it is seeking 60 individuals from a single location to partake in this research endeavour."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Acute Alcohol Response In Bipolar Disorder: a fMRI Study

Elizabeth Thomas Cox Lippard 2019. "Acute Alcohol Response In Bipolar Disorder: a fMRI Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04063384.

All > Bipolar Disorder