A Study to Evaluate EMB 001 in Subjects With Cocaine Use Disorder
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).
This study is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group, study
 to compare the safety and efficacy of EMB-001 with a placebo control in approximately 80
 subjects with moderate-to-severe CUD. Subjects will receive investigational medicinal product
 (IMP) during a 12-week, double-blind Treatment Period (Week 2 through Week 13) and a 1-week,
 double-blind Taper Period (Week 14).

 After undergoing study procedures during the Screening and Baseline Periods, subjects who
 meet inclusion and exclusion criteria will then be randomized in a 1:1 ratio (n=40/arm) to
 one of the following for the Treatment Period (weeks 2 - 13) on Study Day 8:

 -  EMB-001 720 mg metyrapone/24 mg oxazepam mg BID, for a total daily dose of 1440 mg
 metyrapone and 48 mg oxazepam (Active Group)

 -  Placebo BID, (Placebo Group)

 During the Taper Period (week 14), subjects in the Active Group will receive EMB-001 240/8 mg
 BID; and the Placebo Group will continue to receive placebo. Both groups will change from
 taking three capsules BID (twice daily) to one capsule BID (twice daily).

 There will be a follow-up visit for safety assessments at Week 18.
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