The purpose of this study is to determine if ondansetron as an add-on therapy is associated with greater reduction in depressive symptoms and alcohol use than placebo in outpatients with bipolar disorder (BPD) and alcohol-use disorder.
We will also examine if ondansetron as an add-on therapy is associated with a greater reduction in manic symptoms and/or alcohol craving than placebo.
The exploratory analyses aim to determine if ondansetron is associated with greater improvement in cognition and if alcohol use/craving is associated with reduction in manic and depressive symptoms with this group.
This is a 12-week, randomized, double-blind, parallel-group, placebo-controlled study looking to enroll 70 participants who are currently depressed with BPD and early-onset alcohol use disorder. The study is open to English-speaking outpatient men and women age 18-65 years old who are currently on mood stabilizer therapy or be willing to start within 14 days prior to starting study.
Participants must not have a severe or life-threatening medical condition (e.g., hepatic cirrhosis), have a high risk for suicide, or be considered part of a vulnerable population (e.g. pregnant, cognitively impaired, or incarcerated). We do, however, encourage all patients to call the researchers to be screened for the study criteria.
Our recent research findings have shown ondansetron (a serotonin receptor antagonist approved by the FDA as an antiemetic) to be a promising medication to treat alcohol dependence and improve negative mood symptoms.
Frequently Asked Questions
Q: What medication will I be given?
A: Enrolled participants will either receive the study medication (ondansetron) or a placebo (a pill that looks the same but has no active ingredients).
Q: What will my visits consist of?
A: Each visit will consist of structured assessments and laboratory tests administered by a research assistant and psychiatrist.
Q: Is compensation available for participation in the study?
A: Yes, patients will be compensated for their time and efforts contributed for the study.
Q: Is transportation available for the study appointments?
A: Yes. DART passes will be made available to study participants who need transportation assistance.