Citicoline for Bipolar 1 Disorder and Cocaine Dependence
Status:
Completed
Trial end date:
2012-04-01
Target enrollment:
Participant gender:
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.