Ignite Creation Date:
2025-12-26 @ 11:47 AM
Ignite Modification Date:
2025-12-26 @ 11:47 AM
Study NCT ID:
NCT04933916
Status:
TERMINATED
Last Update Posted:
2023-08-09
First Post:
2021-06-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of EMB-001 as a Potential Smoking Cessation Treatment
Sponsor:
Embera NeuroTherapeutics, Inc.
Organization:
Study Overview
Official Title:
Efficacy and Safety of Combination EMB-001 as a Potential Smoking Cessation Treatment
Status:
TERMINATED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Business decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: