Phase 3
N=34
Trial of Citicoline Therapy in Patients With Mania or Hypomania and Cocaine Abuse/Dependence
Mania · Hypomania · Cocaine Abuse · Cocaine Dependence
Bottom Line
View on ClinicalTrials.gov: NCT00223236 ↗Enrolled (actual)
34
Serious AEs
6.8%
Results posted
Aug 2014
Primary outcome: Primary: Cocaine Use Determined by Urine Analysis — 62.50; 50.00 percentage of participants no cocaine — p=.4637
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Citicoline (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cocaine Use Determined by Urine Analysis |
62.50; 50.00 | .4637 |
| SECONDARY Inventory of Depressive Symptomatology Self Report (IDS-SR). |
-20.54; -11.89 | — |
| SECONDARY Young Mania Rating Scale(YMRS). |
-2.00; -2.88 | — |
| SECONDARY Rey Auditory Verbal Learning Test(RAVLT) |
7.06; 3.14 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00223236). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.