Trial Outcomes & Findings for Disease Management for Smoking Cessation (NCT NCT00440115)
NCT ID: NCT00440115
Last Updated: 2017-06-07
Results Overview
Self-reported 7-day point prevalence abstinence from cigarettes
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
750 participants
Primary outcome timeframe
24 months
Results posted on
2017-06-07
Participant Flow
Smokers screened for eligibility (n=1827) Ineligible (n=714) Invited to participate (n=1113) Declined to participate (n=305) Unable to contact (n=58) Randomly assigned (n=750)
Participant milestones
| Measure |
High-intensity Disease Management
Health education mailings, free nicotine replacement therapy or bupropion, 6 motivational interviewing/counseling sessions
|
Moderate-intensity Disease Management
Health education mailings, free nicotine replacement therapy or bupropion, 2 motivational interviewing/counseling sessions
|
Pharmacotherapy Management (Comparison Group)
Health education mailings, free nicotine replacement therapy or bupropion
|
|---|---|---|---|
|
Overall Study
STARTED
|
251
|
249
|
250
|
|
Overall Study
COMPLETED
|
244
|
238
|
244
|
|
Overall Study
NOT COMPLETED
|
7
|
11
|
6
|
Reasons for withdrawal
| Measure |
High-intensity Disease Management
Health education mailings, free nicotine replacement therapy or bupropion, 6 motivational interviewing/counseling sessions
|
Moderate-intensity Disease Management
Health education mailings, free nicotine replacement therapy or bupropion, 2 motivational interviewing/counseling sessions
|
Pharmacotherapy Management (Comparison Group)
Health education mailings, free nicotine replacement therapy or bupropion
|
|---|---|---|---|
|
Overall Study
Death
|
7
|
9
|
5
|
|
Overall Study
Incarceration
|
0
|
2
|
1
|
Baseline Characteristics
Disease Management for Smoking Cessation
Baseline characteristics by cohort
| Measure |
High-intensity Disease Management
n=251 Participants
Health education mailings, free nicotine replacement therapy or bupropion, 6 motivational interviewing/counseling sessions
|
Moderate-intensity Disease Management
n=249 Participants
Health education mailings, free nicotine replacement therapy or bupropion, 2 motivational interviewing/counseling sessions
|
Pharmacotherapy Management (Comparison Group)
n=250 Participants
Health education mailings, free nicotine replacement therapy or bupropion
|
Total
n=750 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
46.4 years
STANDARD_DEVIATION 13.5 • n=5 Participants
|
48.2 years
STANDARD_DEVIATION 12.4 • n=7 Participants
|
47.1 years
STANDARD_DEVIATION 13.4 • n=5 Participants
|
47.2 years
STANDARD_DEVIATION 13.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
151 Participants
n=5 Participants
|
144 Participants
n=7 Participants
|
144 Participants
n=5 Participants
|
439 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
100 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
311 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
249 Participants
n=5 Participants
|
243 Participants
n=7 Participants
|
246 Participants
n=5 Participants
|
738 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 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
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
221 Participants
n=5 Participants
|
225 Participants
n=7 Participants
|
225 Participants
n=5 Participants
|
671 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
251 Participants
n=5 Participants
|
249 Participants
n=7 Participants
|
250 Participants
n=5 Participants
|
750 Participants
n=4 Participants
|
|
Stage of change
Precontemplation
|
23 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
|
Stage of change
Contemplation
|
146 Participants
n=5 Participants
|
153 Participants
n=7 Participants
|
158 Participants
n=5 Participants
|
457 Participants
n=4 Participants
|
|
Stage of change
Preparation
|
82 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
228 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: We used generalized linear models for the primary endpoint (self-reported abstinence at 24 months). Missing values were imputed as smokers, deaths and incarcerations were excluded from analysis.
Self-reported 7-day point prevalence abstinence from cigarettes
Outcome measures
| Measure |
High-intensity Disease Management
n=244 Participants
Health education mailings, free nicotine replacement therapy or bupropion, 6 motivational interviewing/counseling sessions
|
Moderate-intensity Disease Management
n=238 Participants
Health education mailings, free nicotine replacement therapy or bupropion, 2 motivational interviewing/counseling sessions
|
Pharmacotherapy Management (Comparison Group)
n=244 Participants
Health education mailings, free nicotine replacement therapy or bupropion
|
|---|---|---|---|
|
7-day Point Prevalence Abstinence From Cigarettes
|
68 Participants
|
56 Participants
|
56 Participants
|
SECONDARY outcome
Timeframe: 6, 12, 18, 24 monthsNumber of quit attempts at 6, 12, 18, and 24 months. A quit attempt is defined as use of quit-smoking pharmacotherapy (nicotine patch or bupropion) during each treatment period.
Outcome measures
| Measure |
High-intensity Disease Management
n=251 Participants
Health education mailings, free nicotine replacement therapy or bupropion, 6 motivational interviewing/counseling sessions
|
Moderate-intensity Disease Management
n=249 Participants
Health education mailings, free nicotine replacement therapy or bupropion, 2 motivational interviewing/counseling sessions
|
Pharmacotherapy Management (Comparison Group)
n=250 Participants
Health education mailings, free nicotine replacement therapy or bupropion
|
|---|---|---|---|
|
Number of Quit Attempts
Month 6 : No Quit Attempt
|
78 quit attempts
|
85 quit attempts
|
105 quit attempts
|
|
Number of Quit Attempts
Month 6 : Quit Attempted
|
171 quit attempts
|
160 quit attempts
|
142 quit attempts
|
|
Number of Quit Attempts
Month 6 : Deceased/Incarcerated
|
2 quit attempts
|
4 quit attempts
|
3 quit attempts
|
|
Number of Quit Attempts
Month 12 : Quit Attempted
|
95 quit attempts
|
93 quit attempts
|
114 quit attempts
|
|
Number of Quit Attempts
Month 12 : Deceased/Incarcerated
|
3 quit attempts
|
5 quit attempts
|
3 quit attempts
|
|
Number of Quit Attempts
Month 12 : No Quit Attempt
|
153 quit attempts
|
151 quit attempts
|
133 quit attempts
|
|
Number of Quit Attempts
Month 18 : Quit Attempted
|
61 quit attempts
|
49 quit attempts
|
65 quit attempts
|
|
Number of Quit Attempts
Month 18 : Deceased/Incarcerated
|
6 quit attempts
|
9 quit attempts
|
3 quit attempts
|
|
Number of Quit Attempts
Month 18 : No Quit Attempt
|
184 quit attempts
|
191 quit attempts
|
182 quit attempts
|
|
Number of Quit Attempts
Month 24 : Quit Attempted
|
59 quit attempts
|
65 quit attempts
|
55 quit attempts
|
|
Number of Quit Attempts
Month 24 : Deceased/Incarcerated
|
7 quit attempts
|
11 quit attempts
|
6 quit attempts
|
|
Number of Quit Attempts
Month 24 : No Quit Attempt
|
185 quit attempts
|
173 quit attempts
|
189 quit attempts
|
SECONDARY outcome
Timeframe: 6, 12, 18, 24 monthsProgress in Stages of Change at 6, 12, 18, and 24 months
Outcome measures
| Measure |
High-intensity Disease Management
n=251 Participants
Health education mailings, free nicotine replacement therapy or bupropion, 6 motivational interviewing/counseling sessions
|
Moderate-intensity Disease Management
n=249 Participants
Health education mailings, free nicotine replacement therapy or bupropion, 2 motivational interviewing/counseling sessions
|
Pharmacotherapy Management (Comparison Group)
n=250 Participants
Health education mailings, free nicotine replacement therapy or bupropion
|
|---|---|---|---|
|
Progress in Stage of Change
Month 12 · Pre-contemplation
|
25 Participants
|
34 Participants
|
24 Participants
|
|
Progress in Stage of Change
Month 18 · Quit (Action/Maintenance)
|
63 Participants
|
49 Participants
|
44 Participants
|
|
Progress in Stage of Change
Month 18 · Unknown
|
60 Participants
|
49 Participants
|
31 Participants
|
|
Progress in Stage of Change
Month 6 · Pre-contemplation
|
24 Participants
|
25 Participants
|
15 Participants
|
|
Progress in Stage of Change
Month 6 · Contemplation
|
65 Participants
|
74 Participants
|
89 Participants
|
|
Progress in Stage of Change
Month 6 · Preparation
|
87 Participants
|
84 Participants
|
98 Participants
|
|
Progress in Stage of Change
Month 6 · Quit (Action/Maintenance)
|
43 Participants
|
37 Participants
|
28 Participants
|
|
Progress in Stage of Change
Month 6 · Unknown
|
30 Participants
|
25 Participants
|
17 Participants
|
|
Progress in Stage of Change
Month 6 · Deceased/Incarcerated
|
2 Participants
|
4 Participants
|
3 Participants
|
|
Progress in Stage of Change
Month 12 · Contemplation
|
70 Participants
|
71 Participants
|
83 Participants
|
|
Progress in Stage of Change
Month 12 · Preparation
|
50 Participants
|
57 Participants
|
79 Participants
|
|
Progress in Stage of Change
Month 12 · Quit (Action/Maintenance)
|
59 Participants
|
50 Participants
|
38 Participants
|
|
Progress in Stage of Change
Month 12 · Unknown
|
44 Participants
|
32 Participants
|
23 Participants
|
|
Progress in Stage of Change
Month 12 · Deceased/Incarcerated
|
3 Participants
|
5 Participants
|
3 Participants
|
|
Progress in Stage of Change
Month 18 · Pre-contemplation
|
23 Participants
|
31 Participants
|
17 Participants
|
|
Progress in Stage of Change
Month 18 · Contemplation
|
55 Participants
|
67 Participants
|
81 Participants
|
|
Progress in Stage of Change
Month 18 · Preparation
|
44 Participants
|
44 Participants
|
74 Participants
|
|
Progress in Stage of Change
Month 18 · Deceased/Incarcerated
|
6 Participants
|
9 Participants
|
3 Participants
|
|
Progress in Stage of Change
Month 24 · Pre-contemplation
|
30 Participants
|
32 Participants
|
33 Participants
|
|
Progress in Stage of Change
Month 24 · Contemplation
|
59 Participants
|
61 Participants
|
70 Participants
|
|
Progress in Stage of Change
Month 24 · Preparation
|
31 Participants
|
37 Participants
|
46 Participants
|
|
Progress in Stage of Change
Month 24 · Quit (Action/Maintenance)
|
81 Participants
|
65 Participants
|
66 Participants
|
|
Progress in Stage of Change
Month 24 · Unknown
|
43 Participants
|
43 Participants
|
29 Participants
|
|
Progress in Stage of Change
Month 24 · Deceased/Incarcerated
|
7 Participants
|
11 Participants
|
6 Participants
|
Adverse Events
High-intensity Disease Management
Serious events: 15 serious events
Other events: 63 other events
Deaths: 7 deaths
Moderate-intensity Disease Management
Serious events: 2 serious events
Other events: 46 other events
Deaths: 11 deaths
Pharmacotherapy Management (Comparison Group)
Serious events: 2 serious events
Other events: 19 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
High-intensity Disease Management
n=251 participants at risk
Health education mailings, free nicotine replacement therapy or bupropion, 6 motivational interviewing/counseling sessions
|
Moderate-intensity Disease Management
n=249 participants at risk
Health education mailings, free nicotine replacement therapy or bupropion, 2 motivational interviewing/counseling sessions
|
Pharmacotherapy Management (Comparison Group)
n=250 participants at risk
Health education mailings, free nicotine replacement therapy or bupropion
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Dystonia
|
0.40%
1/251 • Number of events 1
|
0.00%
0/249
|
0.00%
0/250
|
|
Cardiac disorders
Arterial Surgery
|
0.40%
1/251 • Number of events 1
|
0.00%
0/249
|
0.00%
0/250
|
|
Cardiac disorders
Atrial fibriliation
|
0.00%
0/251
|
0.00%
0/249
|
0.40%
1/250 • Number of events 1
|
|
Injury, poisoning and procedural complications
Broken Neck
|
0.40%
1/251 • Number of events 1
|
0.00%
0/249
|
0.00%
0/250
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis/COPD Exacerbation
|
0.80%
2/251 • Number of events 2
|
0.40%
1/249 • Number of events 1
|
0.40%
1/250 • Number of events 1
|
|
Injury, poisoning and procedural complications
Collapsed lung
|
0.40%
1/251 • Number of events 1
|
0.00%
0/249
|
0.00%
0/250
|
|
Cardiac disorders
Congestive Heart Failure
|
0.40%
1/251 • Number of events 1
|
0.00%
0/249
|
0.00%
0/250
|
|
Psychiatric disorders
Depression and Suicidal Ideation
|
0.80%
2/251 • Number of events 2
|
0.00%
0/249
|
0.00%
0/250
|
|
Renal and urinary disorders
Kidney Failure
|
0.40%
1/251 • Number of events 1
|
0.00%
0/249
|
0.00%
0/250
|
|
Surgical and medical procedures
Removal of Lung Mass
|
0.40%
1/251 • Number of events 1
|
0.00%
0/249
|
0.00%
0/250
|
|
Injury, poisoning and procedural complications
Smoke Inhalation
|
0.40%
1/251 • Number of events 1
|
0.00%
0/249
|
0.00%
0/250
|
|
Nervous system disorders
Stroke
|
0.00%
0/251
|
0.40%
1/249 • Number of events 1
|
0.00%
0/250
|
|
Gastrointestinal disorders
Ulcer
|
0.40%
1/251 • Number of events 1
|
0.00%
0/249
|
0.00%
0/250
|
|
Cardiac disorders
Heart Surgery
|
0.80%
2/251 • Number of events 2
|
0.00%
0/249
|
0.00%
0/250
|
Other adverse events
| Measure |
High-intensity Disease Management
n=251 participants at risk
Health education mailings, free nicotine replacement therapy or bupropion, 6 motivational interviewing/counseling sessions
|
Moderate-intensity Disease Management
n=249 participants at risk
Health education mailings, free nicotine replacement therapy or bupropion, 2 motivational interviewing/counseling sessions
|
Pharmacotherapy Management (Comparison Group)
n=250 participants at risk
Health education mailings, free nicotine replacement therapy or bupropion
|
|---|---|---|---|
|
Product Issues
Chest Pain
|
0.00%
0/251
|
1.2%
3/249 • Number of events 3
|
0.40%
1/250 • Number of events 1
|
|
Product Issues
Cold Sores
|
0.40%
1/251 • Number of events 1
|
0.00%
0/249
|
0.00%
0/250
|
|
Product Issues
Constipation
|
0.40%
1/251 • Number of events 1
|
0.00%
0/249
|
0.00%
0/250
|
|
Product Issues
Depression
|
0.40%
1/251 • Number of events 1
|
0.40%
1/249 • Number of events 1
|
0.00%
0/250
|
|
Product Issues
Dizziness/Light Headedness
|
0.40%
1/251 • Number of events 1
|
1.2%
3/249 • Number of events 3
|
0.40%
1/250 • Number of events 1
|
|
Product Issues
Elevated heart rate or blood pressure
|
1.2%
3/251 • Number of events 3
|
2.4%
6/249 • Number of events 6
|
0.40%
1/250 • Number of events 1
|
|
Infections and infestations
Flu
|
1.2%
3/251 • Number of events 3
|
0.40%
1/249 • Number of events 1
|
0.00%
0/250
|
|
Product Issues
Headache
|
0.00%
0/251
|
1.6%
4/249 • Number of events 4
|
0.00%
0/250
|
|
Vascular disorders
Blood Clot
|
0.40%
1/251 • Number of events 1
|
0.40%
1/249 • Number of events 1
|
0.00%
0/250
|
|
Gastrointestinal disorders
Bowel Falure
|
0.40%
1/251 • Number of events 1
|
0.00%
0/249
|
0.00%
0/250
|
|
Injury, poisoning and procedural complications
Broken Bone
|
0.80%
2/251 • Number of events 2
|
0.00%
0/249
|
0.40%
1/250 • Number of events 1
|
|
Injury, poisoning and procedural complications
Concussion
|
0.40%
1/251 • Number of events 1
|
0.00%
0/249
|
0.00%
0/250
|
|
Gastrointestinal disorders
Crohn's Disease Complication
|
0.40%
1/251 • Number of events 1
|
0.00%
0/249
|
0.00%
0/250
|
|
Endocrine disorders
Diabetes Complication
|
0.40%
1/251 • Number of events 1
|
0.00%
0/249
|
0.00%
0/250
|
|
Injury, poisoning and procedural complications
Eye Injury
|
0.40%
1/251 • Number of events 1
|
0.00%
0/249
|
0.00%
0/250
|
|
Renal and urinary disorders
Kidney Stones
|
0.40%
1/251 • Number of events 1
|
0.00%
0/249
|
0.00%
0/250
|
|
Infections and infestations
Pneumonia
|
2.0%
5/251 • Number of events 5
|
0.40%
1/249 • Number of events 1
|
0.80%
2/250 • Number of events 2
|
|
Infections and infestations
Shingles
|
0.40%
1/251 • Number of events 1
|
0.00%
0/249
|
0.00%
0/250
|
|
Gastrointestinal disorders
Stomach Pain
|
0.00%
0/251
|
0.40%
1/249 • Number of events 1
|
0.00%
0/250
|
|
Infections and infestations
Strep Throat
|
0.40%
1/251 • Number of events 1
|
0.00%
0/249
|
0.00%
0/250
|
|
Surgical and medical procedures
Scheduled Surgery/Medical Procedure
|
3.6%
9/251 • Number of events 9
|
1.2%
3/249 • Number of events 3
|
0.40%
1/250 • Number of events 1
|
|
Product Issues
Irritability/Nervousness
|
0.40%
1/251 • Number of events 1
|
0.80%
2/249 • Number of events 2
|
1.2%
3/250 • Number of events 3
|
|
Product Issues
Nausea
|
2.0%
5/251 • Number of events 5
|
2.8%
7/249 • Number of events 7
|
0.40%
1/250 • Number of events 1
|
|
Product Issues
Nose Bleeds
|
0.40%
1/251 • Number of events 1
|
0.00%
0/249
|
0.00%
0/250
|
|
Product Issues
Shakiness
|
0.80%
2/251 • Number of events 2
|
1.2%
3/249 • Number of events 3
|
0.00%
0/250
|
|
Product Issues
Skin Irritation
|
6.0%
15/251 • Number of events 15
|
3.2%
8/249 • Number of events 8
|
2.8%
7/250 • Number of events 7
|
|
Product Issues
Sleep Disturbance
|
1.6%
4/251 • Number of events 4
|
1.2%
3/249 • Number of events 3
|
0.40%
1/250 • Number of events 1
|
Additional Information
Edward F. Ellerbeck, MD, MPH, Chair
Department of Preventive Medicine & Public Health
Phone: 913-588-2829
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place