Research

Clinical medication development for bipolar disorder and alcohol-use disorders

Purpose

The purpose of this study is to determine if pregnenolone and citicoline are associated with greater reduction in alcohol use than placebo in outpatients with bipolar disorder and alcohol-use disorder.

Biomarkers of alcohol use, alcohol craving, mood, and cognition will also be assessed. Relationships between neurosteroid and choline levels and the outcome measures will be explored.

Summary

A 12-week, randomized, double-blind, parallel-group, placebo-controlled adaptive design study of pregnenolone and citicoline is proposed in 199 persons with alcohol use disorder and bipolar I or II disorder, mood state currently depressed. The study is open to English- and Spanish-speaking outpatient men and women age 18-65 years old, who are currently on mood stabilizer therapy or are willing to start within 21 days prior to starting the 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.

Background

Our recent research findings have shown that both pregnenolone and citicoline are promising medications to treat alcohol dependence and improve negative mood symptoms and cognition.

Frequently Asked Questions

Q: What medication will I be given?

A: Enrolled participants will receive one of three medications: pregnenolone, citicoline, or 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.