Status:
COMPLETED
Citicoline for Bipolar 1 Disorder and Cocaine Dependence
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Bipolar Disorder
Cocaine Dependence
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
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. Pa...
Detailed Description
There will be 13 study visits where patients complete assessments, urine drug screen, and cognitive behavioral therapy (CBT). Patients will need to come to the clinic two more times in the same week t...
Eligibility Criteria
Inclusion
- 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 Diagnostic and Statistical Manual (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 14 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, not otherwise specified (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 14 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, Alcoholics Anonymous (AA), Narcotics Anonymous (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.
Exclusion
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00619723
Start Date
April 1 2008
End Date
April 1 2012
Last Update
January 24 2018
Active Locations (1)
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1
Exchange Park Center, American General Building (Bass)- PNE: FL8, STE 828
Dallas, Texas, United States, 75235