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

Inclusion Criteria:

1. Has signed the ICF and is able to read and understand the information provided in theICF.
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 thelast 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 necessarysurveys.

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 medicalstaff based on all available assessments from the screening period (e.g., safetylaboratory, vital signs, physical examination, ECG, concomitant medications andmedical 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) greaterthan 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-2antibodies, 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, abnormalECG, syncope, cardiac chest pain, or history of heart attack or heart failure. Formales, QTc > 450 msec. For females QTc > 470 msec (using Fridericia correctionformula).
8. Has a history of clinically significant drug/alcohol overdose as judged by theInvestigator.
9. Has alcohol breathalyzer > 0% at screening.
10. Has a current DSM-5 opioid or benzodiazepine use disorder of any severity or use ofthese substances or alcohol in amounts that would increase risk of receiving oxazepamas part of EMB-001 or has received psychotherapy or behavioral treatments potentiallyimpacting symptoms of depression, anxiety, or nicotine withdrawal within 30 days ofscreening, or during the study.
11. Has history of mental illness that, in the opinion of the investigator, may interferewith 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 ofscreen or during study.
13. Use of any of these products in the past 30 days:
14. Illegal drugs (or if the urine drug screen is positive for cocaine, THC,amphetamines, methamphetamines, MDMA (Ecstasy), phencyclidine, benzodiazepines,barbiturates, or opiates at screening);
15. Experimental (investigational) drugs or biologic;
16. Chronic opiate use;
17. Biotin products (Vitamin B7 or B8, Vitamin H, or coenzyme R).
18. Use of glucocorticoids including:
19. Oral glucocorticoids within 90 days of screen or during study;
20. Inhaled glucocorticoids within 90 days of screen or during study;
21. Topical glucocorticoids within 7 days of screen or during the study (except whenapplied to a small body surface area);
22. Joint injection within 90 days of screening or during the study.
23. Donation of any blood components within 84 days of screening or during the study orloss of blood ≥ 400 mL within 84 days of screen.
24. Use of smokeless tobacco (chewing tobacco, snuff), cigars (except for cigarillos),pipes, hookah, e-cigarettes, nicotine replacement therapy or other smoking cessationtreatments within 14 days of enrollment.
25. Pregnant or nursing (by self-report) or has a positive pregnancy test.
26. Female subjects must be of non-childbearing potential. Evidence of non-childbearingpotential includes documented surgical sterilization (hysterectomy or bilateraloophorectomy) or being postmenopausal. Postmenopausal is defined clinically as 12months of amenorrhea in a woman over 45 years of age in the absence of otherbiological or physiological cause. In addition, women must have a documented serumfollicle stimulating hormone (FSH) level > 40 mIU/mL during the Screening Period.
27. Known hypersensitivity to or intolerance of oxazepam, metyrapone, or anybenzodiazepine, or severe hypersensitivity reaction (e.g., angioedema) to any drug.
28. Treatment with an investigational drug or biologic within the 30 days preceding thefirst dose of study medication or plans to take another investigational drug orbiologic within 30 days of study completion (including the follow-up visit).
29. Enrollment requirements met.