Tobacco Use DisorderPhase 1/2NCT04933916
Study of EMB-001 as a Potential Smoking Cessation Treatment
A Phase 1/2 study testing EMB-001 in people with Tobacco Use Disorder, run by Embera NeuroTherapeutics, Inc. at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- EMB-001
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Jun 2021to 1 May 2023
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- 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 ("Thoughts that you would be better off dead, or of hurting yourself in some way") at screening.
- 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 28Show 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.
- Woman of Childbearing Potential
- 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).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Embera Site
Miami Lakes, Florida, 33014
Rose Research Center
Raliegh, North Carolina, 27617
About this study
Official title: Efficacy and Safety of Combination EMB-001 as a Potential Smoking Cessation Treatment
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.
Read the 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.
- Conditions
- Tobacco Use Disorder
- Being tested
- EMB-001
- Keywords
- smoking, tobacco use, smoking cessation
- Medical subject headings
- Tobacco Use Disorder, Smoking, Tobacco Use, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMB-001Drug
Combination product metyrapone and oxazepam
| Study group | Role | What they receive |
|---|---|---|
| EMB-001 Active | Experimental | 720 mg metyrapone/24 mg oxazepam mg BID, for a total daily dose of 1440 mg metyrapone and 48 mg oxazepam Receives: Drug: EMB-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking Abstinence
Abstinence for each subject at each time point will be defined by a self-report of no cigarette smoking (not even a puff) since the prior session, confirmed by an expired air CO reading of less than 5 ppm. The number and percent of subjects who achieve abstinence will be reported. The primary abstinence outcome will be abstinence during study weeks 9-12 (number and percent of subjects who are abstinent at all time points during Weeks 9-12).
Measured: Weeks 9-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start10 Jun 2021
- Primary completion1 Apr 2023
- Study completion1 May 2023
Why it stopped: Business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open-label
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Embera NeuroTherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Foundation for a Smoke Free World INC, Rose Research Center, LLC
- Responsible party
- Sponsor
- Investigators
- Bruce McCarthy, MD, Study chair, Embera NeuroTherapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04933916
- Sponsor's protocol ID
- ERL-T002
- Status last verified
- Nov 2026
- First submitted
- 14 Jun 2021
- Last updated
- 5 Nov 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kablinger AS, Lindner MA, Casso S, Hefti F, DeMuth G, Fox BS, McNair LA, McCarthy BG, Goeders NE. Effects of the combination of metyrapone and oxazepam on cocaine craving and cocaine taking: a double-blind, randomized, placebo-controlled pilot study. J Psychopharmacol. 2012 Jul;26(7):973-81. doi: 10.1177/0269881111430745. Epub 2012 Jan 11.
PubMed 22236504
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Combination EMB-001 as a Potential Smoking Cessation Treatment
- ClinicalTrials.gov ID
- NCT04933916
- Acronym / sponsor ID
- ERL-T002
- Conditions
- Tobacco Use Disorder
- Keywords
- smoking, tobacco use, smoking cessation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Embera NeuroTherapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Foundation for a Smoke Free World INC, Rose Research Center, LLC
- Study start
- 10 Jun 2021 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 22 Jun 2021 (actual)
- Results
- Posted 5 Nov 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label
| Arm | Type | Receives |
|---|---|---|
| EMB-001 Active | Experimental | Drug: EMB-001720 mg metyrapone/24 mg oxazepam mg BID, for a total daily dose of 1440 mg metyrapone and 48 mg oxazepam |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (28 listed)
- 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 ("Thoughts that you would be better off dead, or of hurting yourself in some way") at screening.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMB-001Combination product metyrapone and oxazepam | Drug | EMB-001 Active |
Primary outcome
Smoking Abstinence
Time frame: Weeks 9-12
Abstinence for each subject at each time point will be defined by a self-report of no cigarette smoking (not even a puff) since the prior session, confirmed by an expired air CO reading of less than 5 ppm. The number and percent of subjects who achieve abstinence will be reported. The primary abstinence outcome will be abstinence during study weeks 9-12 (number and percent of subjects who are abstinent at all time points during Weeks 9-12).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22236504Kablinger AS, Lindner MA, Casso S, Hefti F, DeMuth G, Fox BS, McNair LA, McCarthy BG, Goeders NE. Effects of the combination of metyrapone and oxazepam on cocaine craving and cocaine taking: a double-blind, randomized, placebo-controlled pilot study. J Psychopharmacol. 2012 Jul;26(7):973-81. doi: 10.1177/0269881111430745. Epub 2012 Jan 11.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce McCarthy, MD study chair
Embera NeuroTherapeutics, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing EMB-001 in people with Tobacco Use Disorder, run by Embera NeuroTherapeutics, Inc. at 2 sites 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 28 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: stopped early, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Nov 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking Abstinence (time frame: Weeks 9-12). 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 NCT04933916, which also lists 1 linked publication.
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 5 Nov 2026.