Cariprazine for Comorbid Cocaine and Opioid Use Disorder

Subjects will attend two visits per week during the 8-week Outpatient Treatment Phase. Counseling services, in the form of Medication Management (MM) will be provided weekly. A urine sample for drug testing, vitals, AEs, and COWS will be collected/assessed at each visit. At the first weekly visit attended, concomitant medications, medication compliance, AIMS and a blood sample for later analysis of plasma levels of cariprazine and its metabolites will also be collected. The TLFB, C-SSRS, CSSA, SOWS, BSCS, DTS and a UPT (females only) will be collected once weekly. On the final appointment of week 8 only, a physical exam and ECG will be performed and standard laboratory measures (blood chemistry, CBC with differential, fasting glucose and lipids, serum prolactin, medical urinalysis) will be assessed. During week 8, additional assessments will be collected, including the ASI, HAM A/D and Treatment Opinion Form (TOF).

Subjects will attend two visits per week during the 8-week Outpatient Treatment Phase. Counseling services, in the form of Medication Management (MM) will be provided weekly. A urine sample for drug testing, vitals, AEs, and COWS will be collected/assessed at each visit. At the first weekly visit attended, concomitant medications, medication compliance, AIMS and a blood sample for later analysis of plasma levels of cariprazine and its metabolites will also be collected. The TLFB, C-SSRS, CSSA, SOWS, BSCS, DTS and a UPT (females only) will be collected once weekly. On the final appointment of week 8 only, a physical exam and ECG will be performed and standard laboratory measures (blood chemistry, CBC with differential, fasting glucose and lipids, serum prolactin, medical urinalysis) will be assessed. During week 8, additional assessments will be collected, including the ASI, HAM A/D and Treatment Opinion Form (TOF).