Trial Outcomes & Findings for Smoking Cessation Intervention: Effectiveness in Primary Care (NCT NCT00296647)

NCT ID: NCT00296647

Last Updated: 2015-10-14

Results Overview

Primary postquit outcomes was 7-day point prevalence abstinence (0, abstinent; 1, smoking) at 6 months (based on the week 24 interview)

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 1346 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2015-10-14

Participant Flow

Participants were 1346 smokers recruited in 12 Aurora Health Care primary care clinics in eastern Wisconsin from October 2005 through May 2007.

Primary inclusion criteria included (1) 18 years or older; (2) 10 or more cigarettes per day (CPD) for the past 6 months; (3) motivated to quit smoking; and (4) if female, willing to use an acceptable contraception while using the study medication.

Participant milestones

Measure	Patch	Nicotine Lozenge	Bupropion	Patch + Lozenge	Buproion + Lozenge
Overall Study STARTED	282	261	256	279	268
Overall Study COMPLETED	250	233	222	262	248
Overall Study NOT COMPLETED	32	28	34	17	20

Reasons for withdrawal

Measure	Patch	Nicotine Lozenge	Bupropion	Patch + Lozenge	Buproion + Lozenge
Overall Study Death	4	1	2	1	1
Overall Study Withdrawal by Subject	28	27	32	16	19

Baseline Characteristics

Smoking Cessation Intervention: Effectiveness in Primary Care

Baseline characteristics by cohort

Measure	Patch n=282 Participants	Nicotine Lozenge n=261 Participants	Bupropion n=256 Participants	Patch + Lozenge n=279 Participants	Buproion + Lozenge n=268 Participants	Total n=1346 Participants Total of all reporting groups
Age, Continuous	44.5 years STANDARD_DEVIATION 12.4 • n=5 Participants	42.9 years STANDARD_DEVIATION 11.7 • n=7 Participants	44 years STANDARD_DEVIATION 11.6 • n=5 Participants	44.8 years STANDARD_DEVIATION 12.4 • n=4 Participants	45.4 years STANDARD_DEVIATION 12.2 • n=21 Participants	44.3 years STANDARD_DEVIATION 12.1 • n=10 Participants
Sex: Female, Male Female	158 Participants n=5 Participants	142 Participants n=7 Participants	143 Participants n=5 Participants	158 Participants n=4 Participants	152 Participants n=21 Participants	753 Participants n=10 Participants
Sex: Female, Male Male	124 Participants n=5 Participants	119 Participants n=7 Participants	113 Participants n=5 Participants	121 Participants n=4 Participants	116 Participants n=21 Participants	593 Participants n=10 Participants
Region of Enrollment United States	282 participants n=5 Participants	261 participants n=7 Participants	256 participants n=5 Participants	279 participants n=4 Participants	268 participants n=21 Participants	1346 participants n=10 Participants

PRIMARY outcome

Timeframe: 6 months

Population: intent to treat

Primary postquit outcomes was 7-day point prevalence abstinence (0, abstinent; 1, smoking) at 6 months (based on the week 24 interview)

Outcome measures

Measure	Patch n=279 Participants	Lozenge n=261 Participants	Bupropion n=256 Participants	Patch + Lozenge n=279 Participants	Buproion + Lozenge n=268 Participants
6 Month Self-reported Abstinence From Smoking	50 participants	52 participants	45 participants	75 participants	80 participants

Adverse Events

Patch

Serious events: 4 serious events

Other events: 18 other events

Deaths: 0 deaths

Nicotine Lozenge

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

Bupropion

Serious events: 2 serious events

Other events: 12 other events

Deaths: 0 deaths

Patch + Lozenge

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Buproion + Lozenge

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	Patch n=282 participants at risk	Nicotine Lozenge n=261 participants at risk	Bupropion n=256 participants at risk	Patch + Lozenge n=279 participants at risk	Buproion + Lozenge n=268 participants at risk
Cardiac disorders death	1.4% 4/282 • Number of events 4 • 6 months collection at scheduled follow up time points	0.38% 1/261 • Number of events 1 • 6 months collection at scheduled follow up time points	0.78% 2/256 • Number of events 2 • 6 months collection at scheduled follow up time points	0.36% 1/279 • Number of events 1 • 6 months collection at scheduled follow up time points	0.37% 1/268 • Number of events 1 • 6 months collection at scheduled follow up time points

Other adverse events

Measure	Patch n=282 participants at risk	Nicotine Lozenge n=261 participants at risk	Bupropion n=256 participants at risk	Patch + Lozenge n=279 participants at risk	Buproion + Lozenge n=268 participants at risk
Skin and subcutaneous tissue disorders skin irritation	5.3% 15/282 • Number of events 15 • 6 months collection at scheduled follow up time points	1.1% 3/261 • Number of events 3 • 6 months collection at scheduled follow up time points	2.3% 6/256 • Number of events 6 • 6 months collection at scheduled follow up time points	1.8% 5/279 • Number of events 5 • 6 months collection at scheduled follow up time points	1.1% 3/268 • Number of events 3 • 6 months collection at scheduled follow up time points
Gastrointestinal disorders nausea	1.1% 3/282 • Number of events 3 • 6 months collection at scheduled follow up time points	4.6% 12/261 • Number of events 12 • 6 months collection at scheduled follow up time points	2.3% 6/256 • Number of events 6 • 6 months collection at scheduled follow up time points	2.9% 8/279 • Number of events 8 • 6 months collection at scheduled follow up time points	1.1% 3/268 • Number of events 3 • 6 months collection at scheduled follow up time points

Additional Information

Stevens Smith, PhD

UW-Center for Tobacco Research and Intervention

Phone: 608-262-7563

Email: sss@ctri.medicine.wisc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place