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 21-65 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
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.
ZYN 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 nicotine pouches
- Owns a smartphone with text message and data capabilities
- Currently smoke 10 or more cigarettes per day
- Not pregnant, nursing, or planning to become pregnant
- No current serious medical conditions
- Currently live in Charlotte or Winston-Salem, North Carolina, Columbus, Ohio, or Atlanta, Georgia.
2How long is the study?
Your participation in this study will last approximately 12 weeks. Participants will attend a remote visit every two weeks.
3Will I be compensated for my participation in this study?
You will be compensated up to $2,590 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 $20 for completing the first virtual screening visit. Then, you will receive an additional $25 upon completion of the second virtual screening visit ($45 total).
There will be a payment of $150 for supplying a urine sample for NNAL after the second virtual screening visit.
After all screening procedures are completed, and if you are eligible to continue in the study, you will receive $5 a day for responding to daily messages (for up to seven days) asking about the number of cigarettes you are smoking (max $35).
You will receive payment for completing the remote visits every two weeks in the following amounts:
- $100 for remote baseline visit (start of product use period).
- $150 for remote visits at week 2 and week 4 ($300 total).
- $200 for remote visits at week 6 and week 8 ($400 total).
- $250 for remote visits at week 10 and week 12 ($500 total).
- At week 12, once we receive your urine sample, you will receive an additional payment of $150.
- You will receive $10 for responding to questionnaires prior to each remote visit ($70 total).
- You will receive $10 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 84 days ($840 total). If participants are asked by study staff to complete any remote visits outside of the visit schedule above or redo parts of a visit due to equipment malfunctions or other circumstances that are beyond their control, they may be reimbursed for their time. 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 study is being funded by Swedish Match.
The ZYN Study
The main purpose of this study is to see if unrestricted access to flavored ZYN nicotine pouches leads to a greater reduction in smoking than access restricted to unflavored and tobacco flavored ZYN pouches.
The SMART Study
The purpose of this research is to see whether you can decrease your use of your regular cigarette with the use of either the flavored on!® nicotine pouches or the unflavored (Original) on!® nicotine pouches.
SMART FAQ
1What are the criteria to participate?
- Between 22-65 years old
- 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
- Currently smoke 5 or more cigarettes per day
- Has been smoking combustible cigarettes for a year or more
- Own a smartphone with text message and data capabilities
- Currently live in Raleigh, NC, Columbia, SC, Detroit, MI, or Chattanooga, TN.
- No current serious medical conditions
2How long is the study?
Your participation in this study will last approximately 7 weeks, with a 6-month follow-up appointment that is scheduled for 6 months after the end of the 7-week participation period.
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 remote visit. Then an additional $25 for completing the screening surveys and $15 for completing the baseline questionnaires (maximum total $65).
During the 3-7 day baseline period, you will receive $5 a day for responding to daily surveys and $15 per CO measurement collected (maximum total $95).
During week 1, 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. You will also receive $10 for completing weekly surveys at the end of the week and $15 per CO measurement collected (maximum $90).
During week 2, you will receive $7 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. You will also receive $10 for completing weekly surveys at the end of the week and $15 per CO measurement collected (maximum $89).
During week 3, you will receive $9 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. You will also receive $10 for completing weekly surveys at the end of the week and $15 per CO measurement collected (maximum $103).
During week 4, you will receive $11 a day for responding to daily surveys through eResearch. You will also receive $10 for completing weekly surveys at the end of the week and $15 per CO measurement collected (maximum $132).
During week 5, you will receive $13 a day for responding to daily surveys through eResearch. You will also receive $10 for completing weekly surveys at the end of the week and $15 per CO measurement collected (maximum $131).
During week 6, you will receive $15 a day for responding to daily surveys through eResearch. You will also receive $15 for completing questionnaires and $15 per CO measurement collected. To show our appreciation, you will receive a $100 completion bonus once all materials have been returned and received by RRC.(maximum $265).
If you complete a 6-month follow-up, you will receive an additional $50 (maximum $50).
4Who is funding the study?
The study is being funded by Altria, Inc.
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
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?
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.
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.
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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.
