Trial Outcomes & Findings for A Comparative Effectiveness & Long Term Health Study in Wisconsin Smokers (NCT NCT01553084)

Last Updated: 2020-09-02

Results Overview

Self-reported total abstinence from any tobacco use (even a single puff) for the seven days preceding the target follow-up day, confirmed with an exhaled carbon monoxide reading of \<10 ppm..

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

1086 participants

Primary outcome timeframe

Assessed 26 weeks after the target quit day.

Results posted on

2020-09-02

Participant Flow

Participant milestones

Participant milestones
Measure	Effectiveness of Nicotine Patch Only Nicotine Patch: Participants will receive 12 weeks NRT. Patch dosing will be 8 weeks of 21 mg, then 2 weeks of 14 mg, then 2 weeks of 7 mg (those smoking 5-10 cigs/day will receive reduced patch dosing). Medication use will start on the morning of their assigned quit day. They will be urged to use 1 patch/day, unless it produces adverse effects.	Effectiveness of Combination NRT Nicotine lozenge: Participants will receive 12 weeks NRT. Participants will be given 2 mg or 4 mg lozenges based on morning smoking latency, and will be given package insert use instructions. Medication use will start on the morning of their assigned quit day. They will be urged to use at least 5 pieces/day, unless this amount produces adverse effects. Nicotine Patch: Participants will receive 12 weeks NRT. Patch dosing will be 8 weeks of 21 mg, then 2 weeks of 14 mg, then 2 weeks of 7 mg (those smoking 5-10 cigs/day will receive reduced patch dosing). Medication use will start on the morning of their assigned quit day. They will be urged to use 1 patch/day, unless it produces adverse effects.	Effectiveness of Varenicline [Chantix] Varenicline: Participants will receive 12 weeks of pharmacotherapy during the post-quit period plus an additional 7 day pre-quit run-in. Participants will be asked to take a 0.5 mg pill once a day for the first 3 days and then increase to a 0.5 mg pill twice a day (8 hours apart) for 4 days. On the 8th day, their target quit date, they will increase to their target maintenance dose of a 1 mg pill twice daily. If participants report significant adverse events such as nausea, a dose reduction to two 0.5 mg doses per day will be advised.
Overall Study STARTED	241	421	424
Overall Study COMPLETED	226	408	389
Overall Study NOT COMPLETED	15	13	35

Reasons for withdrawal

Reasons for withdrawal
Measure	Effectiveness of Nicotine Patch Only Nicotine Patch: Participants will receive 12 weeks NRT. Patch dosing will be 8 weeks of 21 mg, then 2 weeks of 14 mg, then 2 weeks of 7 mg (those smoking 5-10 cigs/day will receive reduced patch dosing). Medication use will start on the morning of their assigned quit day. They will be urged to use 1 patch/day, unless it produces adverse effects.	Effectiveness of Combination NRT Nicotine lozenge: Participants will receive 12 weeks NRT. Participants will be given 2 mg or 4 mg lozenges based on morning smoking latency, and will be given package insert use instructions. Medication use will start on the morning of their assigned quit day. They will be urged to use at least 5 pieces/day, unless this amount produces adverse effects. Nicotine Patch: Participants will receive 12 weeks NRT. Patch dosing will be 8 weeks of 21 mg, then 2 weeks of 14 mg, then 2 weeks of 7 mg (those smoking 5-10 cigs/day will receive reduced patch dosing). Medication use will start on the morning of their assigned quit day. They will be urged to use 1 patch/day, unless it produces adverse effects.	Effectiveness of Varenicline [Chantix] Varenicline: Participants will receive 12 weeks of pharmacotherapy during the post-quit period plus an additional 7 day pre-quit run-in. Participants will be asked to take a 0.5 mg pill once a day for the first 3 days and then increase to a 0.5 mg pill twice a day (8 hours apart) for 4 days. On the 8th day, their target quit date, they will increase to their target maintenance dose of a 1 mg pill twice daily. If participants report significant adverse events such as nausea, a dose reduction to two 0.5 mg doses per day will be advised.
Overall Study Withdrawal by Subject	15	13	35

Baseline Characteristics

A Comparative Effectiveness & Long Term Health Study in Wisconsin Smokers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Effectiveness of Nicotine Patch Only n=241 Participants Nicotine Patch: Participants will receive 12 weeks NRT. Patch dosing will be 8 weeks of 21 mg, then 2 weeks of 14 mg, then 2 weeks of 7 mg (those smoking 5-10 cigs/day will receive reduced patch dosing). Medication use will start on the morning of their assigned quit day. They will be urged to use 1 patch/day, unless it produces adverse effects.	Effectiveness of Combination NRT n=421 Participants Nicotine lozenge: Participants will receive 12 weeks NRT. Participants will be given 2 mg or 4 mg lozenges based on morning smoking latency, and will be given package insert use instructions. Medication use will start on the morning of their assigned quit day. They will be urged to use at least 5 pieces/day, unless this amount produces adverse effects. Nicotine Patch: Participants will receive 12 weeks NRT. Patch dosing will be 8 weeks of 21 mg, then 2 weeks of 14 mg, then 2 weeks of 7 mg (those smoking 5-10 cigs/day will receive reduced patch dosing). Medication use will start on the morning of their assigned quit day. They will be urged to use 1 patch/day, unless it produces adverse effects.	Effectiveness of Varenicline [Chantix] n=424 Participants Varenicline: Participants will receive 12 weeks of pharmacotherapy during the post-quit period plus an additional 7 day pre-quit run-in. Participants will be asked to take a 0.5 mg pill once a day for the first 3 days and then increase to a 0.5 mg pill twice a day (8 hours apart) for 4 days. On the 8th day, their target quit date, they will increase to their target maintenance dose of a 1 mg pill twice daily. If participants report significant adverse events such as nausea, a dose reduction to two 0.5 mg doses per day will be advised.	Total n=1086 Participants Total of all reporting groups
Age, Continuous	49.4 years STANDARD_DEVIATION 10.9 • n=5 Participants	47.1 years STANDARD_DEVIATION 11.7 • n=7 Participants	48.5 years STANDARD_DEVIATION 11.8 • n=5 Participants	48.1 years STANDARD_DEVIATION 11.6 • n=4 Participants
Sex: Female, Male Female	125 Participants n=5 Participants	219 Participants n=7 Participants	222 Participants n=5 Participants	566 Participants n=4 Participants
Sex: Female, Male Male	116 Participants n=5 Participants	202 Participants n=7 Participants	202 Participants n=5 Participants	520 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	6 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	72 Participants n=5 Participants	117 Participants n=7 Participants	120 Participants n=5 Participants	309 Participants n=4 Participants
Race (NIH/OMB) White	158 Participants n=5 Participants	287 Participants n=7 Participants	283 Participants n=5 Participants	728 Participants n=4 Participants
Race (NIH/OMB) More than one race	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants	22 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants	18 Participants n=4 Participants
Region of Enrollment United States	241 participants n=5 Participants	421 participants n=7 Participants	424 participants n=5 Participants	1086 participants n=4 Participants

PRIMARY outcome

Timeframe: Assessed 26 weeks after the target quit day.

Self-reported total abstinence from any tobacco use (even a single puff) for the seven days preceding the target follow-up day, confirmed with an exhaled carbon monoxide reading of \<10 ppm..

Outcome measures

Outcome measures
Measure	Effectiveness of Nicotine Patch Only n=241 Participants Nicotine Patch: Participants will receive 12 weeks NRT. Patch dosing will be 8 weeks of 21 mg, then 2 weeks of 14 mg, then 2 weeks of 7 mg (those smoking 5-10 cigs/day will receive reduced patch dosing). Medication use will start on the morning of their assigned quit day. They will be urged to use 1 patch/day, unless it produces adverse effects.	Effectiveness of Combination NRT n=421 Participants Nicotine lozenge: Participants will receive 12 weeks NRT. Participants will be given 2 mg or 4 mg lozenges based on morning smoking latency, and will be given package insert use instructions. Medication use will start on the morning of their assigned quit day. They will be urged to use at least 5 pieces/day, unless this amount produces adverse effects. Nicotine Patch: Participants will receive 12 weeks NRT. Patch dosing will be 8 weeks of 21 mg, then 2 weeks of 14 mg, then 2 weeks of 7 mg (those smoking 5-10 cigs/day will receive reduced patch dosing). Medication use will start on the morning of their assigned quit day. They will be urged to use 1 patch/day, unless it produces adverse effects.	Effectiveness of Varenicline [Chantix] n=424 Participants Varenicline: Participants will receive 12 weeks of pharmacotherapy during the post-quit period plus an additional 7 day pre-quit run-in. Participants will be asked to take a 0.5 mg pill once a day for the first 3 days and then increase to a 0.5 mg pill twice a day (8 hours apart) for 4 days. On the 8th day, their target quit date, they will increase to their target maintenance dose of a 1 mg pill twice daily. If participants report significant adverse events such as nausea, a dose reduction to two 0.5 mg doses per day will be advised.
Biochemically-confirmed 7-Day Point-Prevalence Abstinence at 26 Weeks	63 Participants	124 Participants	108 Participants

SECONDARY outcome

Timeframe: Assessed from the target quit day through 26 weeks.

Population: Participants who did not relapse were censored in the survival analysis.

The number of days to relapse is defined as the number of days from the target quit day until the first of seven consecutive days of smoking.

Outcome measures

Outcome measures
Measure	Effectiveness of Nicotine Patch Only n=241 Participants Nicotine Patch: Participants will receive 12 weeks NRT. Patch dosing will be 8 weeks of 21 mg, then 2 weeks of 14 mg, then 2 weeks of 7 mg (those smoking 5-10 cigs/day will receive reduced patch dosing). Medication use will start on the morning of their assigned quit day. They will be urged to use 1 patch/day, unless it produces adverse effects.	Effectiveness of Combination NRT n=421 Participants Nicotine lozenge: Participants will receive 12 weeks NRT. Participants will be given 2 mg or 4 mg lozenges based on morning smoking latency, and will be given package insert use instructions. Medication use will start on the morning of their assigned quit day. They will be urged to use at least 5 pieces/day, unless this amount produces adverse effects. Nicotine Patch: Participants will receive 12 weeks NRT. Patch dosing will be 8 weeks of 21 mg, then 2 weeks of 14 mg, then 2 weeks of 7 mg (those smoking 5-10 cigs/day will receive reduced patch dosing). Medication use will start on the morning of their assigned quit day. They will be urged to use 1 patch/day, unless it produces adverse effects.	Effectiveness of Varenicline [Chantix] n=424 Participants Varenicline: Participants will receive 12 weeks of pharmacotherapy during the post-quit period plus an additional 7 day pre-quit run-in. Participants will be asked to take a 0.5 mg pill once a day for the first 3 days and then increase to a 0.5 mg pill twice a day (8 hours apart) for 4 days. On the 8th day, their target quit date, they will increase to their target maintenance dose of a 1 mg pill twice daily. If participants report significant adverse events such as nausea, a dose reduction to two 0.5 mg doses per day will be advised.
Number of Days to Relapse	29.3 Days Standard Deviation 42.4	37.4 Days Standard Deviation 46.5	31.7 Days Standard Deviation 46.7

SECONDARY outcome

Timeframe: Assessed for the first seven days after the target quit date.

Defined as at least 1 day of abstinence during the first 7 days after the target quit day.

Outcome measures

Outcome measures
Measure	Effectiveness of Nicotine Patch Only n=241 Participants Nicotine Patch: Participants will receive 12 weeks NRT. Patch dosing will be 8 weeks of 21 mg, then 2 weeks of 14 mg, then 2 weeks of 7 mg (those smoking 5-10 cigs/day will receive reduced patch dosing). Medication use will start on the morning of their assigned quit day. They will be urged to use 1 patch/day, unless it produces adverse effects.	Effectiveness of Combination NRT n=421 Participants Nicotine lozenge: Participants will receive 12 weeks NRT. Participants will be given 2 mg or 4 mg lozenges based on morning smoking latency, and will be given package insert use instructions. Medication use will start on the morning of their assigned quit day. They will be urged to use at least 5 pieces/day, unless this amount produces adverse effects. Nicotine Patch: Participants will receive 12 weeks NRT. Patch dosing will be 8 weeks of 21 mg, then 2 weeks of 14 mg, then 2 weeks of 7 mg (those smoking 5-10 cigs/day will receive reduced patch dosing). Medication use will start on the morning of their assigned quit day. They will be urged to use 1 patch/day, unless it produces adverse effects.	Effectiveness of Varenicline [Chantix] n=424 Participants Varenicline: Participants will receive 12 weeks of pharmacotherapy during the post-quit period plus an additional 7 day pre-quit run-in. Participants will be asked to take a 0.5 mg pill once a day for the first 3 days and then increase to a 0.5 mg pill twice a day (8 hours apart) for 4 days. On the 8th day, their target quit date, they will increase to their target maintenance dose of a 1 mg pill twice daily. If participants report significant adverse events such as nausea, a dose reduction to two 0.5 mg doses per day will be advised.
Number of Participants With Initial Cessation in the First 7 Days Post-quit	176 Participants	339 Participants	289 Participants

SECONDARY outcome

Timeframe: Assessed at Baseline and Year 3

Population: Includes only participants who completed both Baseline and Year 3 CIMT measurements.

Change in carotid intima-media thickness (CIMT) from Baseline to Year 3 as a function of smoking status (abstinent versus smoking) at Year 3. Change is calculated as Baseline CIMT score minus Year 3 CIMT score. CIMT score is thickness of the carotid intima-media in millimeters (mm). Lower CIMT values indicate a better outcome.

Outcome measures

Outcome measures
Measure	Effectiveness of Nicotine Patch Only n=190 Participants Nicotine Patch: Participants will receive 12 weeks NRT. Patch dosing will be 8 weeks of 21 mg, then 2 weeks of 14 mg, then 2 weeks of 7 mg (those smoking 5-10 cigs/day will receive reduced patch dosing). Medication use will start on the morning of their assigned quit day. They will be urged to use 1 patch/day, unless it produces adverse effects.	Effectiveness of Combination NRT n=522 Participants Nicotine lozenge: Participants will receive 12 weeks NRT. Participants will be given 2 mg or 4 mg lozenges based on morning smoking latency, and will be given package insert use instructions. Medication use will start on the morning of their assigned quit day. They will be urged to use at least 5 pieces/day, unless this amount produces adverse effects. Nicotine Patch: Participants will receive 12 weeks NRT. Patch dosing will be 8 weeks of 21 mg, then 2 weeks of 14 mg, then 2 weeks of 7 mg (those smoking 5-10 cigs/day will receive reduced patch dosing). Medication use will start on the morning of their assigned quit day. They will be urged to use 1 patch/day, unless it produces adverse effects.	Effectiveness of Varenicline [Chantix] Varenicline: Participants will receive 12 weeks of pharmacotherapy during the post-quit period plus an additional 7 day pre-quit run-in. Participants will be asked to take a 0.5 mg pill once a day for the first 3 days and then increase to a 0.5 mg pill twice a day (8 hours apart) for 4 days. On the 8th day, their target quit date, they will increase to their target maintenance dose of a 1 mg pill twice daily. If participants report significant adverse events such as nausea, a dose reduction to two 0.5 mg doses per day will be advised.
The Effects of Quitting Smoking vs. Continued Smoking on Change in Carotid Intima-media Thickness (CIMT).	-0.0682 millimeters (mm) Standard Deviation 0.0689	-0.0620 millimeters (mm) Standard Deviation 0.0755	—

Adverse Events

Effectiveness of Nicotine Patch Only

Serious events: 0 serious events

Other events: 164 other events

Deaths: 5 deaths

Effectiveness of Combination NRT

Serious events: 0 serious events

Other events: 281 other events

Deaths: 6 deaths

Effectiveness of Varenicline [Chantix]

Serious events: 1 serious events

Other events: 353 other events

Deaths: 5 deaths

Serious adverse events

Serious adverse events
Measure	Effectiveness of Nicotine Patch Only n=241 participants at risk Nicotine Patch: Participants will receive 12 weeks NRT. Patch dosing will be 8 weeks of 21 mg, then 2 weeks of 14 mg, then 2 weeks of 7 mg (those smoking 5-10 cigs/day will receive reduced patch dosing). Medication use will start on the morning of their assigned quit day. They will be urged to use 1 patch/day, unless it produces adverse effects.	Effectiveness of Combination NRT n=421 participants at risk Nicotine lozenge: Participants will receive 12 weeks NRT. Participants will be given 2 mg or 4 mg lozenges based on morning smoking latency, and will be given package insert use instructions. Medication use will start on the morning of their assigned quit day. They will be urged to use at least 5 pieces/day, unless this amount produces adverse effects. Nicotine Patch: Participants will receive 12 weeks NRT. Patch dosing will be 8 weeks of 21 mg, then 2 weeks of 14 mg, then 2 weeks of 7 mg (those smoking 5-10 cigs/day will receive reduced patch dosing). Medication use will start on the morning of their assigned quit day. They will be urged to use 1 patch/day, unless it produces adverse effects.	Effectiveness of Varenicline [Chantix] n=424 participants at risk Varenicline: Participants will receive 12 weeks of pharmacotherapy during the post-quit period plus an additional 7 day pre-quit run-in. Participants will be asked to take a 0.5 mg pill once a day for the first 3 days and then increase to a 0.5 mg pill twice a day (8 hours apart) for 4 days. On the 8th day, their target quit date, they will increase to their target maintenance dose of a 1 mg pill twice daily. If participants report significant adverse events such as nausea, a dose reduction to two 0.5 mg doses per day will be advised.
Immune system disorders Allergic Reaction	0.00% 0/241 • Adverse event data were collected for 12 weeks while participants were taking study medication. Study participants were asked: "Since your last contact with us, has there been any change in your medical condition or health?" at 1 week prior to the quit smoking visit (quit day), on the quit day, at week 1, week 4, week 8, and week 12. Participants also could self-initiate symptom reports during other visits or phone calls. Information on All-Cause Mortality was not collected.	0.00% 0/421 • Adverse event data were collected for 12 weeks while participants were taking study medication. Study participants were asked: "Since your last contact with us, has there been any change in your medical condition or health?" at 1 week prior to the quit smoking visit (quit day), on the quit day, at week 1, week 4, week 8, and week 12. Participants also could self-initiate symptom reports during other visits or phone calls. Information on All-Cause Mortality was not collected.	0.24% 1/424 • Number of events 1 • Adverse event data were collected for 12 weeks while participants were taking study medication. Study participants were asked: "Since your last contact with us, has there been any change in your medical condition or health?" at 1 week prior to the quit smoking visit (quit day), on the quit day, at week 1, week 4, week 8, and week 12. Participants also could self-initiate symptom reports during other visits or phone calls. Information on All-Cause Mortality was not collected.

Other adverse events

Additional Information

Stevens S. Smith, Ph.D.

Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health

Phone: 6082627563

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place