Trial of Citicoline Therapy in Patients With Mania or Hypomania and Cocaine Abuse/Dependence (NCT00223236) | Clinical Trial Compass
CompletedPhase 3
Trial of Citicoline Therapy in Patients With Mania or Hypomania and Cocaine Abuse/Dependence
United States44 participantsStarted 2010-07
Plain-language summary
The purpose of this research is to determine if a citicoline supplement is associated with a reduction in cocaine use and craving in patients with bipolar disorder (a mental disorder marked by alternating periods of mania and depression) or schizoaffective disorder/bipolar type (a psychotic disturbance in which there is a mixture of schizophrenic and manic-depressive symptoms) and cocaine abuse/dependence. This research also wants to explore if citicoline supplements are associated with greater improvement in symptoms of mania and on memory and cognition (the mental faculty of perception, reasoning, and judgement) in these patients.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Men and women ages 18-70 years
* History of mania or hypomania (bipolar I,II, not otherwise specified (NOS) or cyclothymic disorder or schizoaffective disorder/bipolar type)
* Early recovery for cocaine abuse/dependence (between 7 days and 12 weeks of enrollment).
* Any current mood state as indicated by structured diagnostic interview
* No psychotropic medication changes within 7 days prior to enrollment.
* English or Spanish speaking
Exclusion Criteria:
* Pregnant/nursing woman
* Current or past citicoline therapy
* Active suicidal or homicidal ideation with plan and intent
* Dementia, mental retardation or other severe cognitive impairment
* Severe or life threatening medical condition
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cocaine Use Determined by Urine Analysis
Timeframe: Biweekly (visit) urine drug screens
Trial details
NCT IDNCT00223236
SponsorUniversity of Texas Southwestern Medical Center