An Add-On Trial of Quetiapine in Patients With Bipolar Disorder and Cocaine Dependence
Condition: Bipolar Disorder; Cocaine Dependence
MeSH terms: Cocaine-Related Disorders; Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine if quetiapine add-on therapy is associated with a
      decrease in cocaine use and craving and a greater improvement in mood.
    

Detailed description: 
      One Hundred (100) outpatients with a diagnosis of bipolar I disorder and cocaine
      abuse/dependence, established by a structured clinical interview and confirmed by a
      psychiatrist, will participate. Eligible participants will be given a physical exam,
      including an eye exam with an ophthalmoscope to rule out serious medical illnesses and
      cataracts. Additionally, medical and psychiatric histories and baseline labs, including CBC
      and a liver panel will be obtained. Blood will be drawn for routine laboratory analyses
      including a complete blood count (CBC) and SMA-20 at baseline and exit. Women of childbearing
      potential will be given a urine pregnancy test. Baseline measures of psychiatric symptoms
      will be assessed with the Hamilton Rating Scale for Depression HRSD, Young Mania Rating Scale
      (YMRS), Inventory of Depression Symptomatology-Self-Report 30-item version (IDS-SR30), and
      the Psychobiology of Recovery in Depression III - Somatic Symptom Scale (PRD-III). Cocaine
      craving will be assessed with Cocaine Craving Questionnaire (CCQ). Drug use will be assessed
      by self-report, with the Addiction Severity Index (ASI) and a urine drug screen (UDS). Two
      UDSs are performed at baseline. Cocaine use in the past week (dollar amount spent/week and
      days used/week) will be assessed by patient self-report. Use of and craving for other
      substances (benzodiazepines, barbiturates, alcohol, opiates, phencyclidine, and cannabis)
      will also be assessed by self-report of dollar amount and days used in the past week, UDSs,
      and with 100-mm single item visual analog craving scales. Side effects will be assessed with
      the Abnormal Involuntary Movement Scale (AIMS), the Simpson-Angus Scale (SAS), and the Barnes
      Akathesia Rating Scale (BARS). Subjects will be randomized and be titrated up to 400 mg/day
      with additional flexible titration after that time to a maximum of 800 mg/day of Quetiapine
      or identical appearing placebo add-on therapy in a double- blind fashion for 12 weeks. At
      each weekly assessment subjects will be evaluated with the HRSD17, IDS-R30, YMRS, CCQ, and a
      UDS, and receive an upward titration of the study drug. The ASI will be repeated every four
      weeks. Further, participants will return one additional time each week for a UDS. At the end
      of the study an unblinded psychiatrist will provide standard open label treatment with
      Quetiapine until the participants can be transferred back to their usual treatment facility.
      Follow up and after care arrangements will be made for each participant near completion of
      the study.
    

Intervention name(s): Quetiapine; PLacebo
Intervention type(s): Drug; Drug
Intervention description(s): Active Quetiapine; Placebo
Other intervention name(s): Active Quetiapine
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: bipolar disorder; cocaine dependence; quetiapine