Clinical Medication Development for Bipolar Disorder and Alcohol Use Disorders
Status:
Recruiting
Trial end date:
2022-03-01
Target enrollment:
Participant gender:
Summary
Preclinical and clinical data as well as mechanistic justification have been presented
suggesting citicoline and pregnenolone are each promising treatments for alcohol use in BPD.
Both appear to have favorable side effect profiles and no known drug-drug interactions. Thus,
they have the potential to be safely used in a dual diagnosis population already taking other
medications. A 12-week, randomized, double-blind, parallel-group, placebo-controlled adaptive
design study of citicoline and pregnenolone is proposed in 199 persons with alcohol use
disorder and bipolar I or II disorder or schizoaffective disorder (bipolar type). The primary
aim will be to assess change in alcohol use. 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.
Phase:
Phase 4
Details
Lead Sponsor:
Sherwood Brown, MD, PhD University of Texas Southwestern Medical Center