Current Studies – Rose Research Center

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Research

Our team of professionals are trained to conduct clinical trials for people who want to quit smoking.

Our trials test medications, behavioral approaches and various combinations of both in an attempt to find the most effective smoking cessation treatment. Our staff is also trained to conduct behavioral counseling.

The BuZonE RCT Study

The main purpose of this research study is to see if taking a combination of zonisamide and bupropion for a short time helps you switch to using only an e-cigarette. 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.

BuZonE RCT FAQ

1What are the criteria to participate?

Between 22-65 years old
Desire to switch to an e-cigarette
Willingness to take study medications as directed
Currently smoke 10 or more cigarettes per day
Able to pass a urine drug test
No current serious medical conditions
No use of other tobacco products in the last 14 days
Lives within driving distance of our offices in Raleigh or Charlotte, NC

2How long is the study?

Your participation in this study will last about 13-14 weeks and will include seven visits to the study center. The initial on-site Screening Visit (Study Visit 1) will last about 2 to 2 ½ hours. All other study visits will last about 1 hour.

3Will I be compensated for my participation in this study?

You will be compensated for your time and inconvenience related to your participation in this study. If you do not complete the study, for any reason, you will be paid for the study visits and tasks you do complete according to the following schedule:

You will receive $25 for completing all of the on-site screening tests at Study Visit 1. In order to combat rising gas prices, you will receive an additional $25 for completing the initial screening visit ($50 total).

You will receive $75 for each completed visit; Study Visit 2 through Study Visit 7 ($450 total).

You will receive $5 a day for responding to daily surveys through eResearch. In order to receive compensation, you will need to answer all of the questions before you receive your next survey. Daily surveys will be sent once per day for approximately 89 days ($445 total).

If you return to the office for a 6-month CO reading you will receive an additional $75.

4Who is funding the study?

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.

CYCLE FAQ

1What are the criteria to participate?

Able to read, understand, and willing to sign an informed consent form (ICF) and complete questionnaires written in English
Between 22-65 years old
Interested in switching to an electronic cigarette
Willing to take study medication
Currently smoke 10 or more cigarettes per day
Not pregnant, nursing, or planning to become pregnant
No current serious medical conditions
Able to pass a urine drug screen
Not using other tobacco products in the last 14 days
Lives within driving distance of our offices in Raleigh or Charlotte, NC

2How long is the study?

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 ½ to 2 hours, and all other study visits will last approximately one hour.

3Will I be compensated for my participation in this study?

You will be compensated up to $1,100 for your time and inconvenience related to your participation in this study. If you do not complete the study, for any reason, you will be paid for the study visits and tasks you do complete according to the following schedule:

You will receive $50 for completing Study Visit 1. If you test positive for illicit drugs you will not be compensated for this visit.

You will receive $100 for each completed visit; Study Visit 2 through Study Visit 6 ($500 total).

You will receive $5 a day for responding to daily surveys through the eResearch application. In order to receive compensation, you will need to answer all of the questions before you receive your next survey. 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. Greenphire will collect your name, address, date of birth, and social security number to activate your debit card. The visit amount will be loaded onto the card within 48 hours of completing that visit. Payment received as compensation for participation in this study is considered taxable income. You are responsible for paying any state, federal or Social Security taxes on the money you receive. If your total payment exceeds $600 in any one calendar year, we are required to report this information to the Internal Revenue Service (IRS). You will be required to provide your Social Security number or tax identification number for payment. If participants are asked by study staff to return to the center to complete or redo parts of a visit due to equipment malfunctions or other circumstances that are beyond their control, they may be reimbursed for mileage. Participants who decide to withdraw from the study will be paid for the part of the study they have completed.

4Who is funding the study?

The CYCLE Study

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 Drug 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.

The Adaptive 2 Study

The main purpose of this study is to see if smokers who respond early to alternative nicotine products can successfully maintain their smoking reduction by continues use of these noncombustible nicotine alternatives for up to 6 months. These alternative nicotine products include nicotine gum, nicotine lozenges, nicotine patches, oral nicotine pouches, or e-cigarettes.

Adaptive 2 FAQ

1What are the criteria to participate?

Between 22-65 years old
Not pregnant, nursing, or planning to become pregnant
Has a smartphone with iOS 16+ or Android 13+
Currently smoke 10 or more cigarettes per day
No current serious medical conditions
No use of other tobacco products
Lives within driving distance of our office in Raleigh, NC

2How long is the study?

Early nicotine responders will be randomized to continued use of alternative nicotine products for either 12 weeks (total time) or 24 weeks (total time). All early responders will be contacted at 9-months, to evaluate their current smoking status. Study duration for early nicotine non-responding participants will be approximately 3-4 weeks (at the end of Telehealth 3).

3Will I be compensated for my participation in this study?

You will be compensated for your time and inconvenience related to your participation in this study via PayPal. You will need to create a PayPal account to receive payment for participation in this study. If you do not complete the study, for any reason, you will be paid for the portions of the study you do complete. Early responders can make up to $1,550 and non-responders can make up to $400. Payment received as compensation for participation in research is considered taxable income. You are responsible for paying any state, federal or Social Security taxes on the money you receive. If your total payment exceeds $600 in any one calendar year, we are required to report this information to the Internal Revenue Service (IRS). You will be required to provide your Social Security number or tax identification number for payment.

4Who is funding the study?

The study is being funded by a grant from Global Action to End Smoking, formerly the Foundation for a Smoke-Free World. Global Action to End Smoking is an independent non-profit organization. The study investigator and study staff are being paid to conduct this study.

AUS FAQ

1What are the criteria to participate?

Between 22-65 years old
Not pregnant, nursing, or planning to become pregnant
Has a smartphone with iOS 12.4+ or Android 12+
Currently smokes cigarettes daily
No current serious medical conditions
No known allergies or sensitivities to any ingredients found in e-cigarette products or any of the components in e-liquids (nicotine, flavor, benzoic acid, propylene glycol and glycerol, menthol, peppermint oil)
Lives within driving distance of our offices in Raleigh, or Charlotte, NC

2How long is the study?

Your participation in this study will last about four weeks and will include 3 visits to the study center. This first visit will include screening procedures and will take about 1-2 hours. The other study visits will last about 30-45 minutes.

3Will I be compensated for my participation in this study?

The maximum compensation you may receive without unscheduled visits is $470. You will be compensated for your time and inconvenience related to your participation in this study. If you do not complete the study, for any reason, you will be paid for the study visits and tasks you do complete according to the following schedule:

You will receive $50 for completing screening procedures at your first visit.

During the four-week product use period you will receive $50 for completing each weekly survey within three days (total $200).

You will receive a payment of $50 for attending study visit 2 and $70 for attending study visit 3 (total $120).

If you complete the entire study and return all study products you will receive an additional payment of $100.

4Who is funding the study?

The study is being funded by Juul Labs, Inc.

The AUS Study

The main purpose of this Study is to better understand how adult smokers use the Study Product and how they feel about it. The Study Product has been developed by Juul Labs, Inc. (“the Sponsor”), to provide adult smokers with an alternative to cigarette smoking.

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For Future

Studies

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.

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.

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