A 12-week, Randomized, Double-blind, Parallel-group, Placebo-controlled Trial of Citicoline as an add-on Therapy Will be Conducted in 200 Outpatients With Bipolar I Disorder and Cocaine Dependence.

Detailed Summary

A 12-week, randomized, double-blind, parallel-group, placebo-controlled trial of citicoline as an add-on therapy will be conducted in 200 outpatients with bipolar I disorder and cocaine dependence. Patients will complete mood and memory assessments weekly, in addition to completing self-report measures for cocaine (and other substances, like alcohol) use and craving. Participants will receive manual-driven Cognitive Behavioral Therapy (CBT: two sessions each week for 4 weeks followed by weekly sessions, total 16 sessions) specifically designed for persons with bipolar 1 disorder and substance abuse, and provided by a therapist with experience in CBT. The sessions may be videotaped for training purposes and may be viewed by the researchers, the therapist, and Dr. Schmitz, a clinical researcher at the University of Texas Houston who is the developer of the CBT for bipolar disorder and substance dependence used in the study. Before being videotaped, the patient will sign an "Authorization for Audio Recordings, Photography, or Other Images for Non-Treatment Purposes" to further understand how the videotape will be used, and by whom. The patient will be given the option to review their videotape to view their therapy session. Once the patient has completed all study procedures, or had discontinued the study, the tape will be destroyed, until then the tape will kept in the patient's confidential study file. Further, patients will return to the clinic three times a week for urine drug tests (UDS). 200 patients are expected to be consented for this study and all study procedures will take place at the clinic on the University of Texas Southwestern Medical Center campus. All non-study medications are not part of the study. Non-study medication will be verbally self-reported by the patient at the time of enrollment into the study. The patient will be responsible for the costs of their non-study related medications. The patient will manage their non-study medications with their personal doctor, including any changes in these medications. However the protocol has concomitant medication algorithm in the event that a change in the medication schedule needs to be made by a study doctor. If a study doctor requests a laboratory test for the patient, it will be paid for by the clinic. Otherwise, the patient will be responsible for all costs (including laboratories) associated with their non-study medications.

Study Details

Timeline

Interventions