Status:
COMPLETED
Trial of Citicoline Therapy in Patients With Mania or Hypomania and Cocaine Abuse/Dependence
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Mania
Hypomania
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief 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 alterna...
Detailed Description
Forty-four outpatients meeting the inclusion and exclusion criteria were enrolled after completing an Institutional Review Board (IRB)-approved informed consent process. Baseline evaluation included a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00223236
Start Date
July 1 2010
End Date
May 1 2012
Last Update
August 11 2014
Active Locations (1)
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1
The UT Southwestern Medical Center of Dallas
Dallas, Texas, United States, 75390-8849