Study of EMB-001 as a Potential Smoking Cessation Treatment

Phase 1/2 Terminated 16 enrolled Embera NeuroTherapeutics, Inc. Foundation for a Smoke Free World INC · collab Rose Research Center, LLC · collab Segal Trials · collab

NaSingle-groupOpen-labelTreatment

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 an open-label study in up to 50 adult subjects to help smokers abstain from smoking during a 12-week trial period.

Timeline

Start: 2021-06-10
Primary completion: 2023-04-01
Completion: 2023-05-01

Outcome

Outcome not reported

Stopped (Business): “Business decision”

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	Metyrapone	Small molecule	720 mg	—
Subject	oxazepam	Small molecule	24 mg	—