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

May 26, 2021 updated by: Rose Research Center, LLC
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.

Study Overview

Status

Recruiting

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • North Carolina
      • Raleigh, North Carolina, United States, 27617
        • Recruiting
        • Rose Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Has signed the ICF and is able to read and understand the information provided in the ICF.
  2. Healthy smokers 21 to 65 years of age (inclusive) at screening.
  3. Smokes an average of at least 10 commercially available cigarettes per day for the last 12 months.
  4. Has an expired air CO reading of at least 10 ppm at screening.
  5. Express a desire to quit smoking within the next 30 days at screening.
  6. Serum Cortisol > 3 μg/dL at screening.
  7. Willing and able to comply with the requirements of the study.
  8. Owns a smart phone with text message and data capabilities compatible with necessary surveys.

Exclusion Criteria:

  1. Is unhealthy or cannot participate in the study for any reason (e.g., medical, psychiatric, and/or social reason) as judged by the Investigator or designated medical staff based on all available assessments from the screening period (e.g., safety laboratory, vital signs, physical examination, ECG, concomitant medications and medical history).
  2. PHQ-9 score greater than 9, or a score greater than 0 on item #9.
  3. Elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than two times the upper limit of normal or history of liver disease.
  4. Have positive serology test results for human immunodeficiency virus (HIV)-1/HIV-2 antibodies, hepatitis B surface antigen, or hepatitis C antibody.
  5. High blood pressure (systolic > 150 mmHg or diastolic >95 mmHg) at screening.
  6. Body mass index (BMI) less than 18.5 kg/m2 or greater than 35.0 kg/m2.
  7. Coronary heart disease, structural cardiac disease, cardiac dysrhythmias, abnormal ECG, syncope, cardiac chest pain, or history of heart attack or heart failure. For males, QTc > 450 msec. For females QTc > 470 msec (using Fridericia correction formula).
  8. Has a history of clinically significant drug/alcohol overdose as judged by the Investigator.
  9. Has alcohol breathalyzer > 0% at screening.
  10. Has a current DSM-5 opioid or benzodiazepine use disorder of any severity or use of these substances or alcohol in amounts that would increase risk of receiving oxazepam as part of EMB-001 or has received psychotherapy or behavioral treatments potentially impacting symptoms of depression, anxiety, or nicotine withdrawal within 30 days of screening, or during the study.
  11. Has history of mental illness that, in the opinion of the investigator, may interfere with subject safety or data integrity.
  12. Taking antidepressants, CNS or psychoactive medications (e.g., antipsychotics, benzodiazepines, hypnotics) or medications that prolong QTc within the last 30 days of screen or during study.
  13. Use of any of these products in the past 30 days:

    1. Illegal drugs (or if the urine drug screen is positive for cocaine, THC, amphetamines, methamphetamines, MDMA (Ecstasy), phencyclidine, benzodiazepines, barbiturates, or opiates at screening);
    2. Experimental (investigational) drugs or biologic;
    3. Chronic opiate use;
    4. Biotin products (Vitamin B7 or B8, Vitamin H, or coenzyme R).
  14. Use of glucocorticoids including:

    1. Oral glucocorticoids within 90 days of screen or during study;
    2. Inhaled glucocorticoids within 90 days of screen or during study;
    3. Topical glucocorticoids within 7 days of screen or during the study (except when applied to a small body surface area);
    4. Joint injection within 90 days of screening or during the study.
  15. Donation of any blood components within 84 days of screening or during the study or loss of blood ≥ 400 mL within 84 days of screen.
  16. Use of smokeless tobacco (chewing tobacco, snuff), cigars (except for cigarillos), pipes, hookah, e-cigarettes, nicotine replacement therapy or other smoking cessation treatments within 14 days of enrollment.
  17. Pregnant or nursing (by self-report) or has a positive pregnancy test.
  18. Female subjects must be of non-childbearing potential. Evidence of non-childbearing potential includes documented surgical sterilization (hysterectomy or bilateral oophorectomy) or being postmenopausal. Postmenopausal is defined clinically as 12 months of amenorrhea in a woman over 45 years of age in the absence of other biological or physiological cause. In addition, women must have a documented serum follicle stimulating hormone (FSH) level > 40 mIU/mL during the Screening Period.
  19. Known hypersensitivity to or intolerance of oxazepam, metyrapone, or any benzodiazepine, or severe hypersensitivity reaction (e.g., angioedema) to any drug.
  20. Treatment with an investigational drug or biologic within the 30 days preceding the first dose of study medication or plans to take another investigational drug or biologic within 30 days of study completion (including the follow-up visit).
  21. Enrollment requirements met.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EMB-001
EMB-001 will be administered utilizing capsules which contain 240 mg of metyrapone and 8 mg of oxazepam (240/8 mg). Subjects will be prescribed 3 capsules (total of 720 mg metyrapone and 24 mg oxazepam) taken twice daily for a total of 12 weeks. After week 12, or if indicated and possibly for a subject who is being discontinued early, subjects will take one capsule of EMB-001, 240/8 mg, twice a day for one additional week (taper dose).
EMB-001 is a proprietary combination of metyrapone (a cortisol synthesis inhibitor) and oxazepam (a short to medium acting benzodiazepine).
Other Names:
  • metyrapone
  • oxazepam

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Smoking Abstinence
Time Frame: Weeks 9 through 12
Participant self-report of no cigarette smoking (not even a puff).
Weeks 9 through 12
Smoking Abstinence
Time Frame: 6 month follow-up
Participant self-report of no cigarette smoking (not even a puff).
6 month follow-up
Smoking Abstinence
Time Frame: Week 12
Expired air CO reading of less than 5 ppm
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 19, 2021

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

October 5, 2020

First Submitted That Met QC Criteria

April 27, 2021

First Posted (Actual)

April 30, 2021

Study Record Updates

Last Update Posted (Actual)

May 28, 2021

Last Update Submitted That Met QC Criteria

May 26, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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