Are you ready to make the switch from smoking cigarettes?

The purpose of the CYCLE research study is to explore ways to help smokers transfer their addiction to nicotine from burning cigarettes to a non-combustible alternative nicotine product. The study will try to find out if d-cycloserine (DCS) can help with transferring nicotine dependence from cigarettes to e-cigarettes. 

During this study you will be taking 100 mg of d-cycloserine daily to see if it helps you switch to using only an e-cigarette. DCS is a drug approved by the United States Food and Frug Administration (FDA) for treatment of tuberculosis. The use of DCS is not FDA approved for the purpose of switching from combustible cigarettes to e-cigarette use and is therefore considered investigational for this study. 

• Between the ages of 22-65
• Interested in switching to an electronic cigarette
• Currently smoke 10 or more cigarettes per day, but want to stop
• Willing to take study medication
• No current serious medical conditions
• Able to pass a urine drug test
• Able to read, understand, and willing to sign an informed consent form (ICF) and complete questionnaires written in English
• Not pregnant, nursing, or planning to become pregnant
• Not using other tobacco products in the last 14 days

Your participation in this study will last approximately 12 weeks and will include six visits to the study center. The Screening Session (study Visit 1) will last approximately 1 1/2 to 2 hours, and all other study visits will last approximately one hour. 

The maximum compensation you may receive without unscheduled visits is $1,100. If you do not complete the study, for any reason, you will be paid for the study visits you do complete according to the following schedule:

• $50 for completing Study Visit 1.
• $100 for each completed visit; Study Visit 2 through Study Visit 6 ($500 total).
• $5 a day for responding to daily surveys through the eResearch application. Daily surveys will be sent once per day for approximately 95 days (approximately $475 total).
• If you return to the office for a 6-month CO reading you will receive an additional $75.

You will receive compensation via the Greenphire ClinCard, a prepaid MasterCard debit card. 

You will be required to provide you Social Security number or tax identification number for payment.

Participants who decide to withdraw from the study will be paid for the part of the study they have completed. 

If you agree to take part in this research study, information about your identity, health and your participation will be collected, recorded, and stored by study staff.

Rose Research Center, the FDA, Altria, other health authorities, and the Institutional Review Board (IRB) may inspect your hard-copy and electronically stored research records which may include your name, address and other personal information that identifies you. If necessary, some of these records may be copied during these inspections.

We will also share your name, address, phone number and social security number with Greenphire which is a payment company that will be used to compensate you.

The results of this research study may be presented at meetings or in publications. 

However, you will not be personally identified in any presentations or publications.

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 study
• 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 important information to consider before joining the study. The study staff 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 the information about the study, you can decide whether or not to digitally 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 staff will let you know in a timely manner of any information that may change your mind about participating.

The study is being funded with a grant from the Foundation for a Smoke-Free World, Inc. (“FAFW”), 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. 

If you have any other questions, please call us at 1-866-984-7673 or visit us at 

www.roseresearchcenter.com.