Citicoline for Bipolar 1 Disorder and Cocaine Dependence
Condition: Bipolar Disorder; Cocaine Dependence
MeSH terms: Cocaine-Related Disorders; Bipolar Disorder
Intervention: Citicoline; Placebo; Cognitive Behavioral Therapy (CBT)
Intervention description: Citicoline is a psychostimulant/nootropic. It is an intermediate in the generation of phosphatidylcholine from choline.; Inactive ingredient matching the active medication in appearance.; 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.
Intervention MeSH terms: Choline; Cytidine Diphosphate Choline
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 130.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

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. 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. The sessions may be videotaped for training purposes and may be
      viewed by the researchers, the therapist, and Dr. Schmitz, a clinical researcher at the
      University of Texas Houston who is the developer of the CBT for bipolar disorder and
      substance dependence used in the study. Before being videotaped, the patient will sign an
      "Authorization for Audio Recordings, Photography, or Other Images for Non-Treatment Purposes"
      to further understand how the videotape will be used, and by whom. The patient will be given
      the option to review their videotape to view their therapy session. Once the patient has
      completed all study procedures, or had discontinued the study, the tape will be destroyed,
      until then the tape will kept in the patient's confidential study file. 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 University of Texas 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.
    

Eligibility 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 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.