A Study of Metyrapone and Oxazepam Combination Product (EMB-001) and Cocaine

Phase 1 Completed 18 enrolled Embera NeuroTherapeutics, Inc. National Institute on Drug Abuse (NIDA) · collab

RandomizedCrossoverTriple-blindTreatment

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 Phase 1b cocaine interaction study is being conducted in order to assess the safety and PK of EMB-001 and cocaine in combination.

Timeline

Start: 2016-07
Primary completion: 2017-02-17
Completion: 2017-07-25

Publications

Background Kablinger AS, Lindner MA, Casso S, Hefti F, DeMuth G, Fox BS, McNair LA, McCarthy BG, Goeders NE. Effects of the combination of metyrapone and oxazepam on cocaine craving and cocaine taking: a double-blind, randomized, placebo-controlled pilot study. J Psychopharmacol. 2012 Jul;26(7):973-81. doi: 10.1177/0269881111430745. Epub 2012 Jan 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cocaine	Small molecule	20 mg	Intravenous
Subject	Cocaine	Small molecule	40 mg	Intravenous
Subject	Metyrapone	Small molecule	720 mg	Oral
Subject	oxazepam	Small molecule	24 mg	Oral

A Study of Metyrapone and Oxazepam Combination Product (EMB-001) and Cocaine

Summary

Timeline

Publications

Drugs

Indications