NCT04933916

Study of EMB-001 as a Potential Smoking Cessation Treatment

Efficacy and Safety of Combination EMB-001 as a Potential Smoking Cessation Treatment

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Embera NeuroTherapeutics, Inc. · Industry
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This an exploratory, single-group, open-label study of up to 50 subjects to evaluate the effects on smoking cessation and the safety and tolerability of EBM-001 in smokers. After obtaining informed consent, adult smokers will be enrolled into the study. There will be an observational period of at least five days to obtain baseline data on use of combustible cigarettes. Subjects who meet inclusion and exclusion criteria will be treated with EMB-001 (720 mg metyrapone/24 mg oxazepam mg BID, for a total daily dose of 1440 mg metyrapone and 48 mg oxazepam) for a 12-week period, followed by a one week taper. During the Taper Period, subjects will receive EMB-001 240/8 mg BID. There will be a follow-up visit for safety assessments at Week 15.

Conditions

• Tobacco Use Disorder

Interventions

Type	Name	Description
DRUG	EMB-001	Combination product metyrapone and oxazepam

Timeline

• Start date: 2021-06-10
• Primary completion: 2023-04-01
• Completion: 2023-05-01
• First posted: 2021-06-22
• Last updated: 2023-08-09

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study