Trial of Citicoline Therapy in Patients With Mania or Hypomania and Cocaine Abuse/Dependence

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Treatments: Choline; Cocaine; Cytidine Diphosphate Choline

Criteria

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