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We are investigating a medication combination that may help. See if you qualify!
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Participant information is maintained in a volunteer database system and retained for future studies as they become available.
By clicking submit you agree to the Rose Research Center Terms and Conditions and that we may contact you via text, email, and/or phone unless you later withdraw your consent. Message and data rates may apply.
What should I expect as a research participant?
When you call RRC to inquire about being a clinical study participant, a member of the RRC study team will discuss study specifics and will ask you questions about your medical history. If you meet the criteria for participation in the study we will ask you to come to our office for a screening visit.
During the screening visit, a study team member will talk to you about the study. You will be given information about why the study is being conducted, the procedures involved in your participation and any risks and benefits. You will have an opportunity to ask any questions so that you can make an informed decision about whether or not you would like to participate in the study.
If you decide that you would like to participate, you will be asked to sign a consent form outlining all the information that you discussed with the study staff. After consent is obtained you will be scheduled for the additional study sessions.
During the screening visit, a study team member will talk to you about the study. You will be given information about why the study is being conducted, the procedures involved in your participation and any risks and benefits. You will have an opportunity to ask any questions so that you can make an informed decision about whether or not you would like to participate in the study.
If you decide that you would like to participate, you will be asked to sign a consent form outlining all the information that you discussed with the study staff. After consent is obtained you will be scheduled for the additional study sessions.
FAQs
What is the purpose of this clinical trial?
The purpose of this research study is to see if the study drug, called EMB-001 helps you quit smoking cigarettes. EMB-001 is an investigational drug that includes two drugs, metyrapone and oxazepam. Each of these drugs has been approved previously by the FDA for use alone, for purposes other than quitting smoking. Metyrapone is a drug used to test for problems with the adrenal glands. Oxazepam is a drug used to treat anxiety or alcohol withdrawal symptoms. The use of these drugs together is investigational and has not been approved by the FDA. However, the study is being conducted under FDA research guidelines and procedures.
What are the criteria to participate?
Between 21-65 years old and able to pass a urine drug screening.
Smokes at least 10 cigarettes per day.
Are not currently diagnosed with any serious medical or psychological conditions.
Have not used any electronic cigarettes, vapes, chewing tobacco, cigars, pipes, hookahs, or nicotine replacement therapy (nicotine patches, lozenges, gum, etc.) in the last 2 weeks.
Because these two drugs are not FDA approved to be used together, females must be unable to become pregnant during the course of this study. This means women must be post-menopausal or surgically sterile.
Must not have recently used any of the following: illegal drugs, investigation drugs, SSRIs, antidepressants, antipsychotics, opiates, biotin products, glucocorticoids (oral, inhaled, or topical), or joint injections.
How long is the study?
Your participation in this study will last about 16-17 weeks and will include twelve (12) visits to the study center. This Screening Session (Study Visit 1) and Study Visit 3 will last approximately two to three hours, and all other study visits will last approximately one hour.
Will I receive compensation for my participation?
Yes. You will be compensated up to $2,225 plus $5/day for completing daily surveys for your time and inconvenience related to your participation in this study.
Who is funding the study?
The study is being funded by Embera NeuroTherapeutics. Inc. The study investigator and research staff are being paid by them to conduct this study. The Foundation for a Smoke-Free World paid for the manufacturing of the study drug. The Foundation for a Smoke-Free World is an independent non-profit organization that receives funding from Philip Morris International (a company which manufactures cigarettes).
What is informed consent?
The informed consent process provides you with the information required to ensure you make an informed decision about participation in the clinical research study. This process will:
- Help you to understand the information
- Give you an opportunity to ask questions and to consider whether to participate
- Obtain your voluntary agreement to participate
- Continue to provide information as the clinical research study progresses
Before participating, we will take you through a written Informed Consent Form (ICF) that outlines the important information to consider before joining the study. The study doctor will go through this document with you and answer any questions you may have. This document provides details of the study, such as study expectations, duration, and what you will need to do. All known possible risks and potential benefits are also explained in the ICF.
After you have read and discussed all of the information about the study, you can decide whether or not to sign the consent form. This consent form is not a contract and you are always free to leave the study at any time and for any reason, with no penalty to you. Additionally, during your participation, the study doctor will let you know in a timely manner of any information that may change your mind about participating.
After you have read and discussed all of the information about the study, you can decide whether or not to sign the consent form. This consent form is not a contract and you are always free to leave the study at any time and for any reason, with no penalty to you. Additionally, during your participation, the study doctor will let you know in a timely manner of any information that may change your mind about participating.
Why should I participate?
Participants may gain access to new research treatments before they are widely available.
Additionally, participants are compensated for their time and receive study-related products and medications at no cost. You may be among the first to benefit if the approach being studied is found to be helpful.
Additionally, participants are compensated for their time and receive study-related products and medications at no cost. You may be among the first to benefit if the approach being studied is found to be helpful.
What are Clinical Trials?
Clinical trials are research studies designed to answer specific questions about safety and effectiveness of investigational drugs, medical devices, procedures or behavioral changes. In most cases clinical trials compare a new medical approach to an existing one or to a placebo.
A placebo is an inactive substance that looks the same as the active substance. Clinical trials can also be conducted on medications that are already approved by the FDA to determine if they may be useful for another condition, or to determine the safety or effectiveness of long-term use.
A placebo is an inactive substance that looks the same as the active substance. Clinical trials can also be conducted on medications that are already approved by the FDA to determine if they may be useful for another condition, or to determine the safety or effectiveness of long-term use.
What is Clinical Research?
Clinical research is intended to advance medical and/or scientific knowledge. This research is not designed to determine the effectiveness of a treatment.
Sign-up today!
Fill out our form below for more information. Participant information is maintained in a volunteer database system and retained for future studies as they become available. Pertinent information is confidentially kept on file to aid in selecting highly qualified candidates for research studies.
