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Study of EMB-001 as a Potential Smoking Cessation Treatment

NCT04933916 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2023-08-09

No results posted yet for this study

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.

Conditions

  • Tobacco Use Disorder

Interventions

DRUG

EMB-001

Combination product metyrapone and oxazepam

Sponsors & Collaborators

  • Foundation for a Smoke Free World INC

    collaborator OTHER

  • Rose Research Center, LLC

    collaborator INDUSTRY

  • Segal Trials

    collaborator UNKNOWN

  • Embera NeuroTherapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Bruce McCarthy, MD · Embera NeuroTherapeutics, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-10
Primary Completion
2023-04-01
Completion
2023-05-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04933916 on ClinicalTrials.gov