AzTrials
AzTrials

Smoking CessationPhase 2/3NCT04868253

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

A Phase 2/3 study testing EMB-01 in people with Smoking Cessation and Tobacco Use Disorder, run by Rose Research Center, LLC at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 21 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Smoking Cessation, Tobacco Use Disorder
What is being tested?
EMB-01
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteUnited States
Study dates
19 May 2021to 31 Dec 2021
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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).
  • PHQ-9 score greater than 9, or a score greater than 0 on item #9.
  • Elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than two times the upper limit of normal or history of liver disease.
  • Have positive serology test results for human immunodeficiency virus (HIV)-1/HIV-2 antibodies, hepatitis B surface antigen, or hepatitis C antibody.
  • High blood pressure (systolic > 150 mmHg or diastolic >95 mmHg) at screening.
  • Body mass index (BMI) less than 18.5 kg/m2 or greater than 35.0 kg/m2.
Show all 29Show fewer
  • 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).
  • Has a history of clinically significant drug/alcohol overdose as judged by the Investigator.
  • Has alcohol breathalyzer > 0% at screening.
  • 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.
  • Has history of mental illness that, in the opinion of the investigator, may interfere with subject safety or data integrity.
  • 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.
  • Use of any of these products in the past 30 days:
  • Illegal drugs (or if the urine drug screen is positive for cocaine, THC, amphetamines, methamphetamines, MDMA (Ecstasy), phencyclidine, benzodiazepines, barbiturates, or opiates at screening);
  • Experimental (investigational) drugs or biologic;
  • Chronic opiate use;
  • Biotin products (Vitamin B7 or B8, Vitamin H, or coenzyme R).
  • Use of glucocorticoids including:
  • Oral glucocorticoids within 90 days of screen or during study;
  • Inhaled glucocorticoids within 90 days of screen or during study;
  • Topical glucocorticoids within 7 days of screen or during the study (except when applied to a small body surface area);
  • Joint injection within 90 days of screening or during the study.
  • 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.
  • 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.
  • Pregnant or nursing (by self-report) or has a positive pregnancy test.
  • 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.
  • Known hypersensitivity to or intolerance of oxazepam, metyrapone, or any benzodiazepine, or severe hypersensitivity reaction (e.g., angioedema) to any drug.
  • 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).
  • Enrollment requirements met.

Trial locations and contacts

1 site in 1 country.

United States1 site, 1 recruiting

  • Rose Research Center

    Raleigh, North Carolina, 27617

    Stacy L Drew, MS, MHS, PA-C, 919-325-2345, stacy.drew@roseresearchcenter.com

    Tanaia Loeback, tanaia.loeback@roseresearchcener.com

    Recruiting

Other trials in United States

About this study

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.

Being tested
EMB-01
Medical subject headings
Smoking Cessation, Tobacco Use Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EMB-01Drug

    Also called metyrapone, oxazepam

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

Study groups in NCT04868253
Study groupRoleWhat they receive
EMB-001ExperimentalEMB-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).
Receives: Drug: EMB-01

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Smoking Abstinence

    Participant self-report of no cigarette smoking (not even a puff).

    Measured: Weeks 9 through 12

  2. Smoking Abstinence

    Participant self-report of no cigarette smoking (not even a puff).

    Measured: 6 month follow-up

  3. Smoking Abstinence

    Expired air CO reading of less than 5 ppm

    Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2021
  2. Study start19 May 2021
  3. Primary completion31 Dec 2021 (estimated)
  4. Study completion31 Dec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04868253
Sponsor's protocol ID
ERL-T002
Status last verified
May 2021
First submitted
5 Oct 2020
Last updated
28 May 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing EMB-01 in people with Smoking Cessation and Tobacco Use Disorder, run by Rose Research Center, LLC at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Smoking Abstinence (time frame: Weeks 9 through 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04868253.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in