Pilot Study for High-Dose Citicoline Therapy in Bipolar I Disorder and Cocaine Dependence
We propose an 8-week open-label, pilot trial for high-dose citicoline in 4 persons with BPD and cocaine dependence. Participants will be recruited from referral sources we have developed over many years. The primary outcome measure will be cocaine-positive urines between groups. This clinical trial will be conducted at uT Southwestern Medical Center. Dr. Brown has conducted every randomized, placebo-controlled trial published, to date, in BPD and cocaine dependence. The research staff is highly experienced in recruitment and assessment of patients with BPD and cocaine dependence. The goal of this small pilot study is to collect some very preliminary safety, tolerability and efficacy data for an niH grant application that will compare high-dose citicoline to the combination of low-dose citicoline and lamotrigine. The data will be used as pilot data for a R01 application to niH that will explore higher dose citicoline vs. the citicoline + lamotrigine combination for cocaine use in bipolar disorder. We also anticipate publishing the findings as a case series in a peer-reviewed journal.
* Men and women age 18-65 years old.
* Outpatients with a diagnosis of bipolar I or II disorder on the SCID and confirmed by interview with PI or co-I. Current diagnosis of cocaine dependence in DSM-IV (cocaine-use disorder in DSM-V), cocaine use (by self-report) within 4 days prior to baseline, and a cocaine-positive urine at baseline.
* Current mood state of depressed or mixed (depression plus mania) based on DSM criteria.
* Baseline MADRS score < 35 and YMRS score < 35. Values were selected to reflect upper limits of severity we encountered in prior research in BPD and substance dependence and should not decrease enrollment.