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Sponsored by: |
University of Texas Southwestern Medical Center |
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Information provided by: | University of Texas Southwestern Medical Center |
ClinicalTrials.gov Identifier: | NCT00619723 |
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 |
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Bipolar Disorder Cocaine Dependence |
Drug: Citicoline |
Phase IV |
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 |
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 |
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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.
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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.
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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.
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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.
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Criteria for Inclusion of Subjects:
Criteria for Exclusion of Subjects:
Contact: Daren Denniston | 214-645-6963 | Daren.Denniston@UTSouthwestern.edu |
Principal Investigator: | Sherwood Brown, MD, PhD | UTSouthwestern Medical Center at Dallas |
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 |
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 |
Nootropic Agents Pathologic Processes Disease |
Therapeutic Uses Central Nervous System Agents Pharmacologic Actions |