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

NCT04868253 | Unknown Phase 2 FDA Drug

• 1 other identifier: ERL-T002
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• Smoking Abstinence

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

  Weeks 9 through 12

• Smoking Abstinence

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

  6 month follow-up

• Smoking Abstinence

  Expired air CO reading of less than 5 ppm

  Week 12

Study Arms (1)

EMB-001

EXPERIMENTAL

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).

Drug: EMB-01

Interventions

EMB-01 DRUG

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

Also known as: metyrapone, oxazepam

EMB-001

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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;

Sponsors & Collaborators

• Rose Research Center, LLC: lead
• Foundation for a Smoke Free World INC: collaborator
• Embera NeuroTherapeutics, Inc.: collaborator

Study Sites (1)

Rose Research Center

Raleigh, North Carolina, 27617, United States

RECRUITING

MeSH Terms

Conditions

Smoking Cessation; Tobacco Use Disorder

Interventions

Metyrapone; Oxazepam

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2020
• First Posted: April 30, 2021
• Study Start: May 19, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: May 28, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)