Double Blind,Placebo Controlled Trial of Citicoline Therapy in Patients With Mania, Hypomania and Cocaine Abuse/Dependence

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sherwood Brown, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00223236
First received: September 15, 2005
Last updated: July 31, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Mania
Hypomania
Cocaine Abuse,Dependence
Drug: Citicoline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-controlled Trial of Citicoline add-on Therapy in Patients With a History of Mania or Hypomania and Cocaine Abuse/Dependence

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Urine Drug Screens [ Time Frame: Three a week ] [ Designated as safety issue: No ]

Enrollment: 130
Study Start Date: July 2010
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Citicoline
Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
Drug: Citicoline
Placebo Comparator: Placebo
Inactive ingredient matching the active medication in appearance

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women ages 18-70 years
  • History of mania or hypomania (bipolar I,II, 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00223236

Locations
United States, Texas
The UT Southwestern Medical Center of Dallas
Dallas, Texas, United States, 75390-8849
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: E. Sherwood Brown, PH.D., M.D. The UT Southwestern Medical Center of Dallas
  More Information

No publications provided

Responsible Party: Sherwood Brown, professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00223236     History of Changes
Other Study ID Numbers: 03T-439
Study First Received: September 15, 2005
Last Updated: July 31, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cocaine-Related Disorders
Bipolar Disorder
Substance-Related Disorders
Mental Disorders
Affective Disorders, Psychotic
Mood Disorders
Cytidine Diphosphate Choline
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014