Clinical trial for Bipolar Disorder
Official title Acute Alcohol Response In Bipolar Disorder: a Longitudinal Alcohol Administration/fMRI Study
ClinicalTrials.gov ID: NCT05838274
What this study is testing
- What it's testing
- This study is testing whether changes in your brain and how you feel after alcohol predict future alcohol problems in young adults with bipolar disorder.
- Who it's for
- You may be able to join if you are 21‑26 years old, have bipolar disorder, and are otherwise healthy.
- What's involved
- You will drink a small amount of alcohol and a pretend drink on different days while brain scans are taken. You will also answer questionnaires about stress and mood.
- Time commitment
- The study lasts about two years with several visits for scans and tests.
You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 26. Healthy volunteers may be eligible.
You may be able to join if
- between 21 and 26 years of age
- having consumed at least 4 (men) or 3 (women) drinks on a single occasion over the last year
- euthymic at the time of enrollment for bipolar disorder participants: \- Meeting Diagnostic and Statistical Manual-5 Research Version (DSM-V-RV)...
You likely can't join if
- history of significant medical illness, particularly if possible changes in cerebral tissue
- neurologic abnormality including significant head trauma (loss of consciousness of ≥5-min)
- full Scale intelligence quotient (IQ) \<85
- contraindication to MRI scanning
- positive pregnancy test
- current cannabis use disorder\>moderate
See the full eligibility criteria
- between 21 and 26 years of age
- having consumed at least 4 (men) or 3 (women) drinks on a single occasion over the last year
- euthymic at the time of enrollment for bipolar disorder participants: \- Meeting Diagnostic and Statistical Manual-5 Research Version (DSM-V-RV) diagnostic criteria for bipolar disorder, confirmed by structured interview
- history of significant medical illness, particularly if possible changes in cerebral tissue
- neurologic abnormality including significant head trauma (loss of consciousness of ≥5-min)
- full Scale intelligence quotient (IQ) \<85
- contraindication to MRI scanning
- positive pregnancy test
- current cannabis use disorder\>moderate
- history of severe AUDs
- scores \> 15 on the alcohol Use Disorders Identification Test (AUDIT; part of phone screen)
- 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
- history of heart attack, heart trouble, high blood pressure, diabetes, or liver disease
- an adverse reaction to alcoholic beverages
- reporting never consuming 4 (men) or 3 (women) or more drinks on a single occasion over the last year
- unwillingness to have a friend or family member drive them home after the alcohol administration sessions
- any prior psychiatric hospitalizations
- lifetime history of a neurodevelopmental disorder, affective disorder, psychotic disorder, eating disorder
- greater than 1 month of lifetime psychotropic medication.
The study team makes the final eligibility decision.
Where it is enrolling
- Austin, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 26 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Austin, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.