Intervention: Citicoline
Trial phase: Phase 4
ATC code: N06BX06
SMILES: C[N+](C)(C)CCOP(=O)([O-])OP(=O)(O)OC[C@H]1O[C@@H](n2ccc(N)nc2=O)[C@H](O)[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 61
Group description: Participants will receive active medication throughout the study. Citicoline 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: Citicoline is a psychostimulant/nootropic. It is an intermediate in the generation of phosphatidylcholine from choline.

Cognitive Behavioral Therapy (CBT): 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.
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.