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

NCT04868253 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2021-05-28

No results posted yet for this study

Summary

This open-label study will evaluate EMB-001, comprised of metyrapone, a cortisol synthesis inhibitor marketed as a diagnostic drug for testing hypothalamic-pituitary-adrenal (HPA) axis function, combined with oxazepam, an anxiolytic and sedative/hypnotic benzodiazepine, to help smokers abstain from smoking during a 12-week trial period.

Conditions

  • Smoking Cessation
  • Tobacco Use Disorder

Interventions

DRUG

EMB-01

EMB-001 is a proprietary combination of metyrapone (a cortisol synthesis inhibitor) and oxazepam (a short to medium acting benzodiazepine).

Sponsors & Collaborators

  • Foundation for a Smoke Free World INC

    collaborator OTHER

  • Embera NeuroTherapeutics, Inc.

    collaborator INDUSTRY

  • Rose Research Center, LLC

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-19
Primary Completion
2021-12-31
Completion
2021-12-31
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 NCT04868253 on ClinicalTrials.gov