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This is a research study to find out if a smoking cessation medications, either varenicline or nicotine replacement products (patches or lozenges), are effective when given to smokers, remotely, as a one-time sample.
Participants will either receive a sample of varenicline, nicotine patches and lozenges, or neither. This will be decided randomly. Participants have a 50%chance of receiving varenicline, a 25% chance of receiving nicotine products, and a 25% chance of receiving neither. If the participant is assigned to a group that receives free samples, they will be mailed to them free of charge. There is no requirement to use them, and it is completely up to the participants. There is also no requirement to quit in this study.
The study lasts for six months, and will involve six total surveys. In addition, investigators ask that participants complete daily diaries (about 1 minute each) for the first 4 weeks of the study. Both varenicline and nicotine replacement products are well-established medications that help smokers quit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Varenicline (.5mg BID) | Experimental | Participants will be randomized in a 2:1:1 ratio to receive a 4-week sample of varenicline (.5 mg, 60 tablets total), NRT, or not, with outcomes assessed through 12 weeks of follow-up. 324 participants will be enrolled in this group. Participants in the varenicline sampling group will be given standard instructions on titration but ultimately will decide on their own as to if and how it is used. Dosing is lower than most industry trials of varenicline (1mg BID) but consistent with two trials of lower dosing that showed efficacy and with fewer side effects. Varenicline participants can choose to titrate 2mg if they wish, with shorter duration of sampling experience. |
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| Nicotine Replacement Therapy (NRT) | Active Comparator | Participants will be randomized in a 2:1:1 ratio to receive a 4-week sample of varenicline, NRT, or not, with outcomes assessed through 12 weeks of follow-up. 162 participants will be enrolled in this group. Participants in NRT group will receive 28 day supply of nicotine patch (1patch x 28 days @ 14mg) and lozenge (14 per day x 28 days @4mg) with instructions to use based on number of cigarettes smoked per day. Like varenicline participants, smokers in NRT group can use as much or as little of the NRT as they wish. |
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| Control Group | No Intervention | Participants will be randomized in a 2:1:1 ratio to receive a 4-week sample of varenicline, NRT, or not, with outcomes assessed through 12 weeks of follow-up. 162 participants will be enrolled in this group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Varenicline 0.5 MG | Drug | varenicline comes in bottles of 56 - 0.5 mg pills |
|
| Measure | Description | Time Frame |
|---|---|---|
| Smoking Cessation | Percentage of participants With 7-day self-reported point prevalence abstinence, among smokers randomized to a) varenicline, b) NRT, or c) no sampling control group | At six-month follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in Smoking | Percentage of participants who have reduced their smoking by at least 50%, at both Week 4 and Week 26 follow-up, among smokers randomized to a) varenicline, b) NRT, or c) no sampling control group | At the week 4 and week 26 follow up follow up |
| Any Quit Attempts |
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Eligibility criteria include:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42101840 | Derived | Carpenter MJ, Smith TT, Wahlquist AE, Toll BA, Cropsey KL, Ware EC, Kaczmar JM, Dahne J, Gray KM. Medication Samples and Smoking Cessation Among Adults: A Randomized Clinical Trial. JAMA Netw Open. 2026 May 1;9(5):e2611418. doi: 10.1001/jamanetworkopen.2026.11418. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Varenicline (.5mg BID) | Participants will be randomized in a 2:1:1 ratio to receive a 4-week sample of varenicline (.5 mg, 60 tablets total), NRT, or not, with outcomes assessed through 12 weeks of follow-up. 324 participants will be enrolled in this group. Participants in the varenicline sampling group will be given standard instructions on titration but ultimately will decide on their own as to if and how it is used. Dosing is lower than most industry trials of varenicline (1mg BID) but consistent with two trials of lower dosing that showed efficacy and with fewer side effects. Varenicline participants can choose to titrate 2mg if they wish, with shorter duration of sampling experience. |
| FG001 | Nicotine Replacement Therapy (NRT) | Participants will be randomized in a 2:1:1 ratio to receive a 4-week sample of varenicline, NRT, or not, with outcomes assessed through 12 weeks of follow-up. 162 participants will be enrolled in this group. Participants in NRT group will receive 28 day supply of nicotine patch (1patch x 28 days @ 14mg) and lozenge (14 per day x 28 days @4mg) with instructions to use based on number of cigarettes smoked per day. Like varenicline participants, smokers in NRT group can use as much or as little of the NRT as they wish. |
| FG002 | Control Group | Participants will be randomized in a 2:1:1 ratio to receive a 4-week sample of varenicline, NRT, or not, with outcomes assessed through 12 weeks of follow-up. 162 participants will be enrolled in this group. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Varenicline (.5mg BID) | Participants will be randomized in a 2:1:1 ratio to receive a 4-week sample of varenicline (.5 mg, 60 tablets total), NRT, or not, with outcomes assessed through 12 weeks of follow-up. 324 participants will be enrolled in this group. Participants in the varenicline sampling group will be given standard instructions on titration but ultimately will decide on their own as to if and how it is used. Dosing is lower than most industry trials of varenicline (1mg BID) but consistent with two trials of lower dosing that showed efficacy and with fewer side effects. Varenicline participants can choose to titrate 2mg if they wish, with shorter duration of sampling experience. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Smoking Cessation | Percentage of participants With 7-day self-reported point prevalence abstinence, among smokers randomized to a) varenicline, b) NRT, or c) no sampling control group | Posted | Number | Percent | At six-month follow up |
|
Six Months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Varenicline (.5mg BID) | Participants will be randomized in a 2:1:1 ratio to receive a 4-week sample of varenicline (.5 mg, 60 tablets total), NRT, or not, with outcomes assessed through 12 weeks of follow-up. 324 participants will be enrolled in this group. Participants in the varenicline sampling group will be given standard instructions on titration but ultimately will decide on their own as to if and how it is used. Dosing is lower than most industry trials of varenicline (1mg BID) but consistent with two trials of lower dosing that showed efficacy and with fewer side effects. Varenicline participants can choose to titrate 2mg if they wish, with shorter duration of sampling experience. Varenicline 0.5 MG: varenicline comes in bottles of 56 - 0.5 mg pills |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Any Related Adverse Event | Investigations | Systematic Assessment | Any Study Related Adverse Even |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | Hollings Cancer Center, Medical University of South Carolina | 843.876.2436 | carpente@musc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 11, 2020 | Jan 30, 2026 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 13, 2024 | Nov 21, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| D016540 | Smoking Cessation |
| D000073869 | Tobacco Smoking |
| D000073865 | Cigarette Smoking |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D015438 | Health Behavior |
| D064424 | Tobacco Use |
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| ID | Term |
|---|---|
| D000068580 | Varenicline |
| D000095488 | Nicotine Replacement Therapy |
| D061485 | Tobacco Use Cessation Devices |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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Participants will be randomized in a 2:1:1 ratio to receive a 4-week sample of varenicline, NRT, or not, with outcomes assessed through 12 weeks of follow-up. Participants in the varenicline sampling group will be given standard instructions on titration but ultimately will decide on their own as to if and how it is used. Dosing is lower than most industry trials of varenicline (1mg BID) but consistent with two trials of lower dosing that showed efficacy and with fewer side effects. Varenicline participants can choose to titrate 2mg if they wish, with shorter duration of sampling experience. Participants in NRT group will receive 28 day supply of nicotine patch (1patch x 28 days @ 14mg) and lozenge (14 per day x 28 days @4mg) with instructions to use based on number of cigarettes smoked per day. Like varenicline participants, smokers in NRT group can use as much or as little of the NRT as they wish.
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| Nicotine Replacement Therapy (NRT) | Drug | 28 day supply of nicotine patch (1 patch x 28 days @ 14 mg) and lozenge (14 per day x 28 days @ 4 mg) |
|
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Any self-defined attempt and any 24-hr quit attempt to stop smoking cigarettes among smokers randomized to a) varenicline, b) NRT, or c) no sampling control group |
| From study enrollment through end of six-month follow up (cumulative percent over six months) |
| Use of Smoking Cessation Medication | Use of either varenicline or NRT (patch or lozenge) among smokers randomized to a) varenicline, b) NRT, or c) no sampling control group | At 4 and 24 week follow-up |
| BG001 | Nicotine Replacement Therapy (NRT) | Participants will be randomized in a 2:1:1 ratio to receive a 4-week sample of varenicline, NRT, or not, with outcomes assessed through 12 weeks of follow-up. 162 participants will be enrolled in this group. Participants in NRT group will receive 28 day supply of nicotine patch (1patch x 28 days @ 14mg) and lozenge (14 per day x 28 days @4mg) with instructions to use based on number of cigarettes smoked per day. Like varenicline participants, smokers in NRT group can use as much or as little of the NRT as they wish. |
| BG002 | Control Group | Participants will be randomized in a 2:1:1 ratio to receive a 4-week sample of varenicline, NRT, or not, with outcomes assessed through 12 weeks of follow-up. 162 participants will be enrolled in this group. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex/Gender, Customized | Number | Percentage of Particpants |
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| Race/Ethnicity, Customized | Number | Percent |
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| Region of Enrollment | Number | participants |
|
| OG001 | Nicotine Replacement Therapy (NRT) | Participants will be randomized in a 2:1:1 ratio to receive a 4-week sample of varenicline, NRT, or not, with outcomes assessed through 12 weeks of follow-up. 162 participants will be enrolled in this group. Participants in NRT group will receive 28 day supply of nicotine patch (1patch x 28 days @ 14mg) and lozenge (14 per day x 28 days @4mg) with instructions to use based on number of cigarettes smoked per day. Like varenicline participants, smokers in NRT group can use as much or as little of the NRT as they wish. |
| OG002 | Control Group | Participants will be randomized in a 2:1:1 ratio to receive a 4-week sample of varenicline, NRT, or not, with outcomes assessed through 12 weeks of follow-up. 162 participants will be enrolled in this group. |
|
|
| Secondary | Reduction in Smoking | Percentage of participants who have reduced their smoking by at least 50%, at both Week 4 and Week 26 follow-up, among smokers randomized to a) varenicline, b) NRT, or c) no sampling control group | Posted | Number | percent | At the week 4 and week 26 follow up follow up |
|
|
|
| Secondary | Any Quit Attempts | Any self-defined attempt and any 24-hr quit attempt to stop smoking cigarettes among smokers randomized to a) varenicline, b) NRT, or c) no sampling control group | Posted | Number | percent | From study enrollment through end of six-month follow up (cumulative percent over six months) |
|
|
|
| Secondary | Use of Smoking Cessation Medication | Use of either varenicline or NRT (patch or lozenge) among smokers randomized to a) varenicline, b) NRT, or c) no sampling control group | Posted | Number | percent | At 4 and 24 week follow-up |
|
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| 0 |
| 318 |
| 0 |
| 318 |
| 222 |
| 318 |
| EG001 | Nicotine Replacement Therapy (NRT) | Participants will be randomized in a 2:1:1 ratio to receive a 4-week sample of varenicline, NRT, or not, with outcomes assessed through 12 weeks of follow-up. 162 participants will be enrolled in this group. Participants in NRT group will receive 28 day supply of nicotine patch (1patch x 28 days @ 14mg) and lozenge (14 per day x 28 days @4mg) with instructions to use based on number of cigarettes smoked per day. Like varenicline participants, smokers in NRT group can use as much or as little of the NRT as they wish. Nicotine Replacement Therapy (NRT): 28 day supply of nicotine patch (1 patch x 28 days @ 14 mg) and lozenge (14 per day x 28 days @ 4 mg) | 0 | 172 | 0 | 172 | 95 | 172 |
| EG002 | Control Group | Participants will be randomized in a 2:1:1 ratio to receive a 4-week sample of varenicline, NRT, or not, with outcomes assessed through 12 weeks of follow-up. 162 participants will be enrolled in this group. | 0 | 161 | 0 | 161 | 69 | 161 |
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| Any NON-Related and Non-Serious Adverse Events | General disorders | Systematic Assessment |
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| D011810 | Quinoxalines |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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