Understanding how alcohol affects young adults with bipolar disorder
Biological Risk Factors for the Prospective Development of Alcohol Use Disorders in Young Adults With Bipolar Disorder and Typically Developing Young Adults
NA · University of Texas at Austin · NCT05838274
This study looks at how alcohol affects young adults with bipolar disorder compared to their peers to see if it leads to problems with drinking over time.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 21 Years to 26 Years |
| Sex | All |
| Sponsor | University of Texas at Austin (other) |
| Locations | 1 site (Austin, Texas) |
| Trial ID | NCT05838274 on ClinicalTrials.gov |
What this trial studies
This study investigates the subjective and neural responses to alcohol in young adults with bipolar disorder compared to their typically developing peers. It involves a placebo-controlled alcohol administration and MRI assessments to explore how these responses change over time and their relationship with alcohol use and symptoms. The study aims to identify biological risk factors that may predict the development of alcohol use disorders in individuals with bipolar disorder, utilizing a longitudinal approach over two years. Participants will undergo clinical assessments and MRI scans at baseline and follow-ups to track changes in sensitivity to alcohol and associated neural changes.
Who should consider this trial
Good fit: Ideal candidates are young adults aged 21-26 who have experienced at least moderate alcohol consumption and are currently euthymic with a diagnosis of bipolar disorder.
Not a fit: Patients with significant medical illnesses, severe alcohol use disorders, or contraindications to MRI may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved interventions and prevention strategies for alcohol use disorders in individuals with bipolar disorder.
How similar studies have performed: While there have been studies on alcohol use disorders, this specific longitudinal approach in the context of bipolar disorder is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Inclusion criteria for all participants: * 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 Inclusion criteria for bipolar disorder participants: \- Meeting Diagnostic and Statistical Manual-5 Research Version (DSM-V-RV) diagnostic criteria for bipolar disorder, confirmed by structured interview Exclusion Criteria: For all subjects exclusion criteria include: * 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 * a past year substance use disorder (other than alcohol, cannabis, or nicotine) Additional exclusion criteria for bipolar disorder participants: \- not taking medications for greater than or equal to 4 weeks (i.e. participants must be stable on medications) Additional exclusion criteria for healthy comparison subjects also include: * any prior psychiatric hospitalizations * lifetime history of a neurodevelopmental disorder, affective disorder, psychotic disorder, eating disorder * greater than 1 month of lifetime psychotropic medication.
Where this trial is running
Austin, Texas
- University of Texas at Austin — Austin, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Elizabeth Lippard, PhD — University of Texas at Austin
- Study coordinator: Research Coordinator
- Email: behavioral.neuroimaging@austin.utexas.edu
- Phone: 5124955198
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Bipolar Disorder, Alcohol Drinking, Alcohol Use Disorder