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Citicoline for Bipolar 1 Disorder and Cocaine Dependence
This study is not yet open for participant recruitment.
Verified by University of Texas Southwestern Medical Center, February 2008
Sponsored by: University of Texas Southwestern Medical Center
Information provided by: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00619723
  Purpose

The primary aim of this study is to determine citicoline treatment is associated with less cocaine use than placebo in outpatients with bipolar 1 disorder and cocaine dependence. The second aim of the study is to determine if citicoline treatment is associated with greater improvement in executive functioning than placebo in outpatients with bipolar 1 disorder and cocaine dependence.

A 12-week, randomized, double-blind, parallel-group, placebo-controlled trial of citicoline as an add-on therapy will be conducted in 200 outpatients with bipolar I disorder and cocaine dependence. Patients will complete mood and memory assessments weekly, in addition to completing self-report measures for cocaine (and other substances, like alcohol) use and craving. Participants will receive manual-driven Cognitive Behavioral Therapy (CBT: two sessions each week for 4 weeks followed by weekly sessions, total 16 sessions) specifically designed for persons with bipolar 1 disorder and substance abuse, and provided by a therapist with experience in CBT. Further, patients will return to the clinic three times a week for urine drug tests (UDS). 200 patients are expected to be consented for this study and all study procedures will take place at the clinic on the UT Southwestern Medical Center campus.

All non-study medications are not part of the study. Non-study medication will be verbally self-reported by the patient at the time of enrollment into the study. The patient will be responsible for the costs of their non-study related medications. The patient will manage their non-study medications with their personal doctor, including any changes in these medications. However the protocol has concomitant medication algorithm in the event that a change in the medication schedule needs to be made by a study doctor. If a study doctor requests a laboratory test for the patient, it will be paid for by the clinic. Otherwise, the patient will be responsible for all costs (including laboratories) associated with their non-study medications.


Condition Intervention Phase
Bipolar Disorder
Cocaine Dependence
Drug: Citicoline
Phase IV

MedlinePlus related topics: Bipolar Disorder
Drug Information available for: 8-Azabicyclo(3.2.1)octane-2-carboxylic acid, 3-(benzoyloxy)-8-methyl-, methyl ester, (1R-(exo,exo))- Cocaine hydrochloride Cytidine diphosphate choline
U.S. FDA Resources
Study Type: Interventional
Study Design: Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
Official Title: Citicoline for Bipolar 1 Disorder and Cocaine Dependence

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

Primary Outcome Measures:
  • The primary aim of this study is to determine citicoline treatment is associated with less cocaine use than placebo in outpatients with bipolar 1 disorder and cocaine dependence. [ Time Frame: two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The second aim of the study is to determine if citicoline treatment is associated with greater improvement in executive functioning than placebo in outpatients with bipolar 1 disorder and cocaine dependence. [ Time Frame: two years ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: March 2008
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Participants will receive active medication or placebo identical in appearance bid throughout the study. Citicoline or placebo will be given beginning at two capsules (500 mg/day) with an increase to four capsules (1000 mg/day) at week 2, six capsules (1500 mg/day) at week 4, and eight capsules (2000 mg/day) at week 6. Doses will be decreased, based on clinician judgment, due to side effects. Citicoline will be purchased from Jarrow Formulas, Los Angeles, California.
Drug: Citicoline
Citicoline or placebo will be given orally beginning at 500 mg/day (two tablets) with an increase to 1000 mg/day (four tablets) at week 2, 1500 mg/day (six tablets) at week 4, and 2000 mg/day (eight tablets) at week 6. Doses will be decreased if needed due to side effects.
2: Placebo Comparator
Participants will receive active medication or placebo identical in appearance bid throughout the study. Citicoline or placebo will be given beginning at two capsules (500 mg/day) with an increase to four capsules (1000 mg/day) at week 2, six capsules (1500 mg/day) at week 4, and eight capsules (2000 mg/day) at week 6. Doses will be decreased, based on clinician judgment, due to side effects. Citicoline will be purchased from Jarrow Formulas, Los Angeles, California.
Drug: Citicoline
Citicoline or placebo will be given orally beginning at 500 mg/day (two tablets) with an increase to 1000 mg/day (four tablets) at week 2, 1500 mg/day (six tablets) at week 4, and 2000 mg/day (eight tablets) at week 6. Doses will be decreased if needed due to side effects.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Criteria for Inclusion of Subjects:

  • Outpatients with a diagnosis of bipolar I disorder on the SCID and confirmed by interview with PI or co-I.
  • Current diagnosis of cocaine dependence, cocaine use (by self-report) within 7 days prior to baseline, and a cocaine-positive urine at baseline
  • Current mood state of depressed or mixed (depression plus mania) based on SCID interview using DSM-IV criteria.
  • Baseline HRSD17 score < 35 and YMRS score < 35.
  • On a stable medication regimen that may include mood stabilizers, antidepressants or other psychotropic medications (e.g. lithium, divalproex/valproic acid) for at least 28 days.
  • Age 18-65 years old.
  • Men and women.
  • English speaking individual, who can also read English. The neurocognitive measures used in this study are not available in any other languages, and must be read by the patient. There is no ability to collect this data in another manner; therefore people unable to read English may not be enrolled for participation in this study.

Criteria for Exclusion of Subjects:

  • Bipolar disorders other than bipolar I (e.g., bipolar II, NOS, or cyclothymic disorders) based on the SCID and confirmed through clinical assessment by PI or co-I.
  • Mental retardation or other severe cognitive impairment, prison or jail inmates, pregnant or nursing women, or women of childbearing age who will not use hormonal contraceptives, abstinence, or other acceptable methods of birth control during the study.
  • Currently experiencing psychotic features (delusions, hallucinations, disorganized thought processes).
  • Initiation of antidepressants, mood stabilizers, or psychotherapy within the past 28 days.
  • High risk for suicide, defined as any suicide attempt in the past 6 months, or current suicidal ideation with plan and intent or a score of ≥ 2 on the suicide item of the HRSD17.
  • Intensive outpatient treatment for substance abuse (however, AA, NA meetings, or weekly therapy/counseling for bipolar disorder or substance use for at least 28 days prior to randomization will be encouraged).
  • Severe or life-threatening medical condition (e.g., hepatic cirrhosis, congestive heart failure, terminal cancer), laboratory or physical examination findings consistent with serious medical illness (e.g., severe edema, atrial fibrillation, dangerously abnormal electrolytes), history of severe alcohol withdrawal in the past (e.g., delirium tremens), or current clinically significant alcohol (Clinical Institute Withdrawal Assessment for Alcohol Scale [CIWA-AR] score > 8 at baseline), opiate (Clinical Opiate Withdrawal Scale [COWS] score > 4 are baseline) or sedative/hypnotic/anxiolytic (Benzodiazepine Withdrawal Symptom Questionnaire [BWSQ] > 2).
  • Drug of choice is not cocaine.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00619723

Contacts
Contact: Daren Denniston 214-645-6963 Daren.Denniston@UTSouthwestern.edu

Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Sherwood Brown, MD, PhD UTSouthwestern Medical Center at Dallas
  More Information

Responsible Party: UT Southwestern Medical Center at Dallas ( E. Sherwood Brown )
Study ID Numbers: 122007-039, 1 R01DA022460-01A2
Study First Received: February 7, 2008
Last Updated: February 20, 2008
ClinicalTrials.gov Identifier: NCT00619723  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Cocaine-Related Disorders
Choline
Affective Disorders, Psychotic
Mental Disorders
Bipolar Disorder
Cytidine Diphosphate Choline
Substance-Related Disorders
Mood Disorders
Disorders of Environmental Origin
Psychotic Disorders
Cocaine

Additional relevant MeSH terms:
Nootropic Agents
Pathologic Processes
Disease
Therapeutic Uses
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009