Study of EMB-001 as a Potential Smoking Cessation Treatment

NCT04933916 | Terminated Phase 1 FDA Drug

• 1 other identifier: ERL-T002
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

Brief 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). This is an open-label study in up to 50 adult subjects to help smokers abstain from smoking during a 12-week trial period.

Conditions

Tobacco Use Disorder

Keywords

smoking; tobacco use; smoking cessation

Outcome Measures

Primary Outcomes (1)

• Smoking Abstinence

  The primary abstinence outcome will be smoking abstinence

  Weeks 9-12

Study Arms (1)

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

Drug: EMB-001

Interventions

EMB-001 DRUG

Combination product metyrapone and oxazepam

EMB-001 Active

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• 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 ("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.
• 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

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

Study Sites (2)

Embera Site

Miami Lakes, Florida, 33014, United States

Location

Rose Research Center

Raleigh, North Carolina, 27617, United States

Location

Related Publications (1)

• 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.

  PMID: 22236504 BACKGROUND

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking; Tobacco Use; Smoking Cessation

Condition Hierarchy (Ancestors)

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

Study Officials

• Bruce McCarthy, MD

  Embera NeuroTherapeutics, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: June 22, 2021
• Study Start: June 10, 2021
• Primary Completion: April 1, 2023
• Study Completion: May 1, 2023
• Last Updated: August 9, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)