Trial Outcomes & Findings for STARS (Smoking Treatment And Remote Sampling) Study (NCT NCT04525755)
NCT ID: NCT04525755
Last Updated: 2026-02-17
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
652 participants
Primary outcome timeframe
At six-month follow up
Results posted on
2026-02-17
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
318
|
172
|
162
|
|
Overall Study
COMPLETED
|
318
|
172
|
161
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
Baseline Characteristics
STARS (Smoking Treatment And Remote Sampling) Study
Baseline characteristics by cohort
| Measure |
Varenicline (.5mg BID)
n=318 Participants
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.
|
Nicotine Replacement Therapy (NRT)
n=172 Participants
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.
|
Control Group
n=161 Participants
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.
|
Total
n=651 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Race/Ethnicity, Customized
Other
|
1.9 Percent
n=25 Participants
|
0 Percent
n=20 Participants
|
3.1 Percent
n=45 Participants
|
1.7 Percent
n=76 Participants
|
|
Age, Continuous
|
52.1 years
STANDARD_DEVIATION 11.9 • n=25 Participants
|
52.0 years
STANDARD_DEVIATION 10.4 • n=20 Participants
|
51.5 years
STANDARD_DEVIATION 11.5 • n=45 Participants
|
51.9 years
STANDARD_DEVIATION 11.4 • n=76 Participants
|
|
Sex/Gender, Customized
Percent Female
|
66.0 Percentage of Particpants
n=25 Participants
|
69.2 Percentage of Particpants
n=20 Participants
|
63.4 Percentage of Particpants
n=45 Participants
|
66.2 Percentage of Particpants
n=76 Participants
|
|
Sex/Gender, Customized
Percent Male
|
34.0 Percentage of Particpants
n=25 Participants
|
30.8 Percentage of Particpants
n=20 Participants
|
36.6 Percentage of Particpants
n=45 Participants
|
33.8 Percentage of Particpants
n=76 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
11.3 Percent
n=25 Participants
|
13.4 Percent
n=20 Participants
|
9.3 Percent
n=45 Participants
|
11.4 Percent
n=76 Participants
|
|
Race/Ethnicity, Customized
White
|
85.2 Percent
n=25 Participants
|
85.5 Percent
n=20 Participants
|
85.1 Percent
n=45 Participants
|
85.3 Percent
n=76 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
1.6 Percent
n=25 Participants
|
1.2 Percent
n=20 Participants
|
2.5 Percent
n=45 Participants
|
1.7 Percent
n=76 Participants
|
|
Region of Enrollment
United States
|
318 participants
n=25 Participants
|
172 participants
n=20 Participants
|
161 participants
n=45 Participants
|
651 participants
n=76 Participants
|
PRIMARY outcome
Timeframe: At six-month follow upPercentage of participants With 7-day self-reported point prevalence abstinence, among smokers randomized to a) varenicline, b) NRT, or c) no sampling control group
Outcome measures
| Measure |
Varenicline (.5mg BID)
n=318 Participants
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.
|
Nicotine Replacement Therapy (NRT)
n=172 Participants
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.
|
Control Group
n=161 Participants
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.
|
|---|---|---|---|
|
Smoking Cessation
|
16.7 Percent
|
8.1 Percent
|
9.9 Percent
|
SECONDARY outcome
Timeframe: At the week 4 and week 26 follow up follow upPercentage 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
Outcome measures
| Measure |
Varenicline (.5mg BID)
n=318 Participants
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.
|
Nicotine Replacement Therapy (NRT)
n=172 Participants
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.
|
Control Group
n=161 Participants
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.
|
|---|---|---|---|
|
Reduction in Smoking
4 week follow-up
|
28.9 percent
|
27.3 percent
|
11.2 percent
|
|
Reduction in Smoking
26 week follow-up
|
33.3 percent
|
25 percent
|
19.25 percent
|
SECONDARY outcome
Timeframe: From study enrollment through end of six-month follow up (cumulative percent over six months)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
Outcome measures
| Measure |
Varenicline (.5mg BID)
n=318 Participants
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.
|
Nicotine Replacement Therapy (NRT)
n=172 Participants
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.
|
Control Group
n=161 Participants
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.
|
|---|---|---|---|
|
Any Quit Attempts
Any self-defined quit attempt over six month follow-up
|
68 percent
|
65 percent
|
58 percent
|
|
Any Quit Attempts
Any 24-hr quit attempt over six month follow-up
|
48 percent
|
40 percent
|
39 percent
|
SECONDARY outcome
Timeframe: At 4 and 24 week follow-upUse of either varenicline or NRT (patch or lozenge) among smokers randomized to a) varenicline, b) NRT, or c) no sampling control group
Outcome measures
| Measure |
Varenicline (.5mg BID)
n=318 Participants
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.
|
Nicotine Replacement Therapy (NRT)
n=172 Participants
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.
|
Control Group
n=161 Participants
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.
|
|---|---|---|---|
|
Use of Smoking Cessation Medication
At 24 week follow-up
|
28 percent
|
48.8 percent
|
16.5 percent
|
|
Use of Smoking Cessation Medication
At 4 week follow-up
|
78.7 percent
|
74.7 percent
|
7.8 percent
|
Adverse Events
Varenicline (.5mg BID)
Serious events: 0 serious events
Other events: 222 other events
Deaths: 0 deaths
Nicotine Replacement Therapy (NRT)
Serious events: 0 serious events
Other events: 95 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 69 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Varenicline (.5mg BID)
n=318 participants at risk
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
|
Nicotine Replacement Therapy (NRT)
n=172 participants at risk
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)
|
Control Group
n=161 participants at risk
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.
|
|---|---|---|---|
|
Investigations
Any Related Adverse Event
|
60.1%
191/318 • Six Months
|
4.1%
7/172 • Six Months
|
42.9%
69/161 • Six Months
|
|
General disorders
Any NON-Related and Non-Serious Adverse Events
|
9.7%
31/318 • Six Months
|
51.2%
88/172 • Six Months
|
42.2%
68/161 • Six Months
|
Additional Information
Principal Investigator
Hollings Cancer Center, Medical University of South Carolina
Phone: 843.876.2436
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place