A Phase 1/2 interventional study of Varenicline 0.5 MG and Nicotine Replacement Therapy (NRT) in Smoking, Smoking Cessation and Tobacco Smoking, sponsored by Medical University of South Carolina. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-17.
Sponsored by Medical University of South Carolina · Phase 1/2, Interventional, and Prevention
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.
268 studies on the registry are indexed under Smoking; 136 are open to participants now.
This study's enrollment of 652 is above the median of 120 across 211 interventional studies indexed under Smoking.
Browse Smoking studies →Medical University of South Carolina is the lead sponsor of 852 studies on the registry; 165 are open to participants now.
Of its 128 completed or terminated interventional studies of FDA-regulated products, 101 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Eligibility criteria include:
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.
Drug: Varenicline 0.5 MG
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.
Drug: 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.
varenicline comes in bottles of 56 - 0.5 mg pills
Also known as: Chantix, Varenicline Pill
28 day supply of nicotine patch (1 patch x 28 days @ 14 mg) and lozenge (14 per day x 28 days @ 4 mg)
Also known as: NRT Sampling, Nicotine Patches and Lozenges, Nicotine Replacement Therapy Sampling, NRT
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
Time frame: At six-month follow up
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
Time frame: At the week 4 and week 26 follow up follow up
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
Time frame: 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
Time frame: At 4 and 24 week follow-up
| Milestone | Varenicline (.5mg BID) | Nicotine Replacement Therapy (NRT) | Control Group |
|---|---|---|---|
| Started | 318 | 172 | 162 |
| Completed | 318 | 172 | 161 |
| Not completed | 0 | 0 | 1 |
| Withdrew: Protocol violation | 0 | 0 | 1 |
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
| Percent | Varenicline (.5mg BID) | Nicotine Replacement Therapy (NRT) | Control Group |
|---|---|---|---|
| Smoking Cessation | 16.7 | 8.1 | 9.9 |
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
| percent | Varenicline (.5mg BID) | Nicotine Replacement Therapy (NRT) | Control Group |
|---|---|---|---|
| 4 week follow-up | 28.9 | 27.3 | 11.2 |
| 26 week follow-up | 33.3 | 25 | 19.25 |
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
| percent | Varenicline (.5mg BID) | Nicotine Replacement Therapy (NRT) | Control Group |
|---|---|---|---|
| Any self-defined quit attempt over six month follow-up | 68 | 65 | 58 |
| Any 24-hr quit attempt over six month follow-up | 48 | 40 | 39 |
Use of either varenicline or NRT (patch or lozenge) among smokers randomized to a) varenicline, b) NRT, or c) no sampling control group
| percent | Varenicline (.5mg BID) | Nicotine Replacement Therapy (NRT) | Control Group |
|---|---|---|---|
| At 4 week follow-up | 78.7 | 74.7 | 7.8 |
| At 24 week follow-up | 28 | 48.8 | 16.5 |
Collected over Six Months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Varenicline (.5mg BID) | 0/318 (0%) | 0/318 (0%) | 222/318 (69.8%) |
| Nicotine Replacement Therapy (NRT) | 0/172 (0%) | 0/172 (0%) | 95/172 (55.2%) |
| Control Group | 0/161 (0%) | 0/161 (0%) | 69/161 (42.9%) |
| Event | Varenicline (.5mg BID) | Nicotine Replacement Therapy (NRT) | Control Group |
|---|---|---|---|
| Any Related Adverse EventInvestigations | 191/318 | 7/172 | 69/161 |
| Any NON-Related and Non-Serious Adverse EventsGeneral disorders | 31/318 | 88/172 | 68/161 |
| Age, Continuous(years) | Varenicline (.5mg BID) | Nicotine Replacement Therapy (NRT) | Control Group | Total |
|---|---|---|---|---|
| Mean | 52.1 ± 11.9 | 52.0 ± 10.4 | 51.5 ± 11.5 | 51.9 ± 11.4 |
| Sex/Gender, Customized(Percentage of Particpants) | Varenicline (.5mg BID) | Nicotine Replacement Therapy (NRT) | Control Group | Total |
|---|---|---|---|---|
| Percent Female | 66.0 | 69.2 | 63.4 | 66.2 |
| Percent Male | 34.0 | 30.8 | 36.6 | 33.8 |
| Race/Ethnicity, Customized(Percent) | Varenicline (.5mg BID) | Nicotine Replacement Therapy (NRT) | Control Group | Total |
|---|---|---|---|---|
| Black or African American | 11.3 | 13.4 | 9.3 | 11.4 |
| White | 85.2 | 85.5 | 85.1 | 85.3 |
| Multiracial | 1.6 | 1.2 | 2.5 | 1.7 |
| Other | 1.9 | 0 | 3.1 | 1.7 |
| Region of Enrollment(participants) | Varenicline (.5mg BID) | Nicotine Replacement Therapy (NRT) | Control Group | Total |
|---|---|---|---|---|
| United States | 318 | 172 | 161 | 651 |
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Medical University of South Carolina