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

The University of Texas System (UT)

Status and phase: Completed; Phase 3

Conditions: Cocaine Dependence; Cocaine Abuse; Mania; Hypomania

Treatments: Drug: Citicoline; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00223236

03T-439

Details and patient eligibility

About

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.

Full 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 medical and psychiatric history, structured diagnostic interview using Diagnostic and Statistical Manual (DSM)-IV criteria, mood assessment with the Inventory of Depressive Symptomatology-Self Report (IDS-SR), Young Mania Rating Scale (YMRS), and cognitive assessment with the Rey Auditory Verbal Learning Test (RAVLT). Alternate but equivalent versions of the RAVLT were used to minimize practice effects with repeated administration. Cocaine use was assessed at each biweekly visit with urine drug screens. Citicoline or placebo was given beginning at one tablet (500 mg)/day with an increase to two tablets (1000 mg/day) at week 2, three tablets (1500 mg/day) at week 4, and four tablets (2000 mg/day) at week 6. Doses were decreased, if needed, due to side effects.

Enrollment: 44 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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44 participants in 2 patient groups, including a placebo group

Citicoline

Active Comparator group

Description:

Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.

Treatment:

Drug: Citicoline

Placebo

Placebo Comparator group

Description:

Inactive ingredient matching the active medication in appearance

Treatment:

Drug: Placebo