A Study to Evaluate EMB 001 in Subjects With Cocaine Use Disorder

EMB-001 is a combination of 2 drugs: the cortisol synthesis inhibitor, metyrapone (Metopirone®), and the benzodiazepine receptor agonist, oxazepam (original trade name Serax®; now marketed as oxazepam (generic) only). This is a Phase 2 study in approximately 80 adult subjects with moderate-to-severe Cocaine Use Disorder (CUD).

Key Inclusion Criteria: * Provide written informed consent prior to any study procedures * 18 to 65 years of age * DSM-5 diagnosis of moderate-to-severe CUD * Seeking treatment for CUD. Subjects with past rehabilitation attempts are eligible if the most recent rehabilitation attempt ended at least 30 days prior to Screening * Female subjects must be of non-childbearing potential * Male subjects must agree to use accepted contraceptive regimens during the study and for at least 90 days after the last dose of the study drug Key Exclusion Criteria: * Any significant current medical conditions * Known hypersensitivity to or intolerance of oxazepam, metyrapone, or any benzodiazepine, or severe hypersensitivity reaction (e.g., angioedema) to any drug * Heightened likelihood of having adrenal insufficiency in the investigator's or designees' opinion * Current court-mandated treatment requirement for a substance-use disorder * Current DSM-5 moderate-to-severe substance use disorder, other than CUD, tobacco or caffeine * Current DSM-5 opioid or benzodiazepine use disorder of any severity