Are you ready to make the switch?
We are investigating two medications that may help. See if you qualify!
We're looking for volunteers who are...
- Between the age of 22-65
- Want to quit smoking cigarettes
- Willing to take study medication
- Currently smoke 10 or more cigarettes per day, but want to stop
- Able to pass a urine drug test
- Not experiencing any serious medical conditions
- Not using other tobacco products in the last 14 days
- Between the age of 22-65
- Want to quit smoking cigarettes
- Willing to take study medication
- Currently smoke 10 or more cigarettes per day, but want to stop
- Able to pass a urine drug test
- Not experiencing any serious medical conditions
- Not using other tobacco products in the last 14 days
Sign-up to participate
Volunteer information will be reviewed by our team and you will be contacted for this study and your interest in future studies.
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 is the BuZonE RCT Study?
The purpose of BuZonE RCT (randomized-controlled trial) is to see if taking a combination of zonisamide and bupropion for a short time helps you switch to using only an e-cigarette.
A maximum of 180 adult male and female cigarette smokers, aged 21-65 years, will be enrolled from Raleigh and Charlotte, North Carolina, and surrounding areas.
Zonisamide is a drug approved by the United States Food and Drug Administration (FDA) for treatment of seizures. Bupropion (also known as Zyban) is a drug approved by the FDA for use as an aid to quit smoking (but not for switching from combustible cigarettes to e-cigarettes). The use of the combination of zonisamide and bupropion is not FDA approved for the purpose of switching from combustible cigarettes to e-cigarette use and is therefore considered investigational for this study.
You will be compensated for the time related to your participation in this study. Your participation in this study will last 13-14 weeks and will include 7 visits to the study center.
A maximum of 180 adult male and female cigarette smokers, aged 21-65 years, will be enrolled from Raleigh and Charlotte, North Carolina, and surrounding areas.
Zonisamide is a drug approved by the United States Food and Drug Administration (FDA) for treatment of seizures. Bupropion (also known as Zyban) is a drug approved by the FDA for use as an aid to quit smoking (but not for switching from combustible cigarettes to e-cigarettes). The use of the combination of zonisamide and bupropion is not FDA approved for the purpose of switching from combustible cigarettes to e-cigarette use and is therefore considered investigational for this study.
You will be compensated for the time related to your participation in this study. Your participation in this study will last 13-14 weeks and will include 7 visits to the study center.
FAQs
What are the benefits to participating in this study?
Gain access to new research treatments before they are widely available and potentially switch to an e-cigarette.
Most authorities on the health effects of smoking, including the U.S. Surgeon General, conclude that most of the diseases caused by smoking are due to inhaling combustion products in smoke. Nicotine, while addictive, is not generally believed to cause cancers associated with smoking, and overall is much less harmful than the complex mixture of toxic byproducts of burning tobacco.
Most authorities on the health effects of smoking, including the U.S. Surgeon General, conclude that most of the diseases caused by smoking are due to inhaling combustion products in smoke. Nicotine, while addictive, is not generally believed to cause cancers associated with smoking, and overall is much less harmful than the complex mixture of toxic byproducts of burning tobacco.
What are the risks to participating in a Clinical Trial?
Side effects will differ from study to study, you will be informed of any expected side effects when you come in for your first visit as well as in the consent form.
How long is the study?
Your participation in this study will last 13-14 weeks and will include 7 visits to the study center.
Will I receive compensation for my participation?
Yes. If you come to all your visits and complete all your questionnaires you will earn as much as $1,400.
Additionally, we hope you are able to switch to an e-cigarette.
Additionally, we hope you are able to switch to an e-cigarette.
Do I need to ask my regular doctor before I can participate in a research study?
Not unless you want to.
You may want to share with them that you will be taking zonisamide and bupropion to potentially help you switch to an e-cigarette. Your doctor may wish to contact our study doctor (with your permission) to request additional information.
You may want to share with them that you will be taking zonisamide and bupropion to potentially help you switch to an e-cigarette. Your doctor may wish to contact our study doctor (with your permission) to request additional information.
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.
Still interested?
Remember, this study will only require 7 visits over 13-14 weeks. Additionally, you could earn up to $1,400 for your time and participation.
What is Clinical Research and who is Sponsoring this Study?
Clinical research is intended to advance medical and/or scientific knowledge.
This study was funded with a grant from the Foundation for a Smoke-Free World, Inc. (“FSFW”), a US nonprofit 501(c)(3) private foundation. The contents, selection, and presentation of facts, as well as any opinions expressed herein are the sole responsibility of the authors and under no circumstances shall be regarded as reflecting the positions of the Foundation for a Smoke-Free World, Inc. FSFW’s mission is to end smoking in this generation.
This study was funded with a grant from the Foundation for a Smoke-Free World, Inc. (“FSFW”), a US nonprofit 501(c)(3) private foundation. The contents, selection, and presentation of facts, as well as any opinions expressed herein are the sole responsibility of the authors and under no circumstances shall be regarded as reflecting the positions of the Foundation for a Smoke-Free World, Inc. FSFW’s mission is to end smoking in this generation.
Ready to switch to an e-cigarette? 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.
