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

• Status: Recruiting
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Embera NeuroTherapeutics, Inc.
• Collaborator: National Institute on Drug Abuse (NIDA)

Criteria

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