Safety and PK Study of BICX104 With or Without Bupropion Compared to Vivitrol

Inclusion criteria

• Willing and able to provide informed consent and to read and understand study documents in English or Spanish
• Female or male subjects aged 18-65 years old
• In good health, as determined by the study physician, based on complete medical history, physical examination, vital signs measurement, ECG, and laboratory tests within normal ranges, to permit treatment.
• Meet subjective and objective measures of being opioid-free prior to study treatment initiation, including negative urine drug screen results at screening and enrollment.
• BMI of 18.5 to 30.0 kg/m2, inclusive.
• Must agree to comply with all study requirements and be willing to complete entire study.
• Persons of childbearing potential agree to use acceptable birth control methods and have periodic urine pregnancy testing done during participation in the study

Exclusion criteria

• Have a history of any psychiatric disorder OR suicidal ideation, behavior, or risk of self-harm as evidenced by endorsement of items 2, 3, 4, or 5 on the C-SSRS
• Have a history of angle-closure glaucoma
• Have a history of epilepsy, seizure disorder, or head trauma with neurological sequelae (e.g., loss of consciousness that required hospitalization); current anorexia nervosa or bulimia; or any other conditions that increase seizure risk in the opinion of the study medical clinician
• Have evidence of second or third degree heart block, atrial fibrillation, atrial flutter, prolongation of the QTc interval (> 450 in males or > 470 in females), or any other finding on the screening ECG that, in the opinion of the study medical clinician, would preclude safe participation in the study
• Have Stage 2 hypertension as determined by the study medical clinician (e.g., greater than or equal to 160/100 in 2 out of 3 readings during screening)
• Have any elevated bilirubin test value, or AST, ALT or alkaline phosphatase > 1.5 times the upper limit of normal, per laboratory criteria
• Have a platelet count <100 x 103/μL; known coagulopathy, or need for anticoagulant therapy during the study
• Have a known allergy or sensitivity to bupropion, naltrexone, or magnesium stearate, or any topical antiseptics or local anesthetics to be used in the implant procedure.
• Have taken an investigational drug in another study within 30 days of study consent
• Have a history of any substance abuse disorder, have been prescribed and taken naltrexone or bupropion within 30 days of study consent, or have been administered Vivitrol® within 60 days of study consent
• Be receiving ongoing treatment with antidepressants, xanthines (i.e., theophylline and aminophylline), systemic corticosteroids, nelfinavir, efavirenz, chlorpromazine, MAOIs, central nervous system stimulants (e.g., Adderall, Ritalin, etc.), or any medication that, in the judgment of the study medical clinician, could interact adversely with study medications
• Have a current pattern of alcohol, benzodiazepine, or other sedative hypnotic use which would preclude safe participation in the study as determined by the study medical clinician
• Require treatment with opioid-containing medications (e.g., opioid analgesics) during the study period
• Have a surgery planned or scheduled during the study period
• Are currently in jail, prison or any inpatient overnight facility as required by court of law or have pending legal action or other situation (e.g., unstable living arrangements) that could prevent participation in the study or in any study activities
• Is prone to skin rashes, keloid scars, or irritation, or has a chronic skin condition or any other condition which might predispose them to adverse reactions to the implant procedure.