Trial Outcomes & Findings for Telephone Counseling and the Distribution of Nicotine Patches to Smokers (NCT NCT00851357)
NCT ID: NCT00851357
Last Updated: 2020-02-13
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
4200 participants
Primary outcome timeframe
7 months post enrollment
Results posted on
2020-02-13
Participant Flow
Participant milestones
| Measure |
Usual Care
Subjects are not mailed nicotine patches; however, we facilitate their use by providing a certificate that can be used by the State Medicaid program and some insurance companies to obtain free patches.
|
Patch (Placebo)
Subjects are mailed patches directly, we will mail 8 weeks of patches. Dosage depends on the number of cigarettes per day (cpd). Light smokers (6-10 cpd) will receive 6 weeks of 14 mg and 2 weeks of 7 mg patches. Heavy smokers (11+ cpd) will receive 4 weeks of 21 mg, 2 weeks of 14 mg and 2 weeks of 7 mg patches. Placebo patches will have no nicotine, but will be packaged to mimic the active patches.
|
Patch (Real)
Subjects are mailed patches directly, we will mail 8 weeks of patches. Dosage depends on the number of cigarettes per day (cpd). Light smokers (6-10 cpd) will receive 6 weeks of 14 mg and 2 weeks of 7 mg patches. Heavy smokers (11+ cpd) will receive 4 weeks of 21 mg, 2 weeks of 14 mg and 2 weeks of 7 mg patches.
|
|---|---|---|---|
|
Overall Study
STARTED
|
1200
|
1201
|
1799
|
|
Overall Study
COMPLETED
|
1200
|
1201
|
1799
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Telephone Counseling and the Distribution of Nicotine Patches to Smokers
Baseline characteristics by cohort
| Measure |
Usual Care
n=1200 Participants
Subjects are not mailed nicotine patches; however, we facilitate their use by providing a certificate that can be used by the State Medicaid program and some insurance companies to obtain free patches.
|
Patch (Placebo)
n=1201 Participants
Subjects are mailed patches directly, we will mail 8 weeks of patches. Dosage depends on the number of cigarettes per day (cpd). Light smokers (6-10 cpd) will receive 6 weeks of 14 mg and 2 weeks of 7 mg patches. Heavy smokers (11+ cpd) will receive 4 weeks of 21 mg, 2 weeks of 14 mg and 2 weeks of 7 mg patches. Placebo patches will have no nicotine, but will be packaged to mimic the active patches.
|
Patch (Real)
n=1799 Participants
Subjects are mailed patches directly, we will mail 8 weeks of patches. Dosage depends on the number of cigarettes per day (cpd). Light smokers (6-10 cpd) will receive 6 weeks of 14 mg and 2 weeks of 7 mg patches. Heavy smokers (11+ cpd) will receive 4 weeks of 21 mg, 2 weeks of 14 mg and 2 weeks of 7 mg patches.
|
Total
n=4200 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
18-24
|
136 Participants
n=5 Participants
|
145 Participants
n=7 Participants
|
205 Participants
n=5 Participants
|
486 Participants
n=4 Participants
|
|
Age, Customized
25-44
|
569 Participants
n=5 Participants
|
534 Participants
n=7 Participants
|
877 Participants
n=5 Participants
|
1980 Participants
n=4 Participants
|
|
Age, Customized
45-64
|
453 Participants
n=5 Participants
|
461 Participants
n=7 Participants
|
648 Participants
n=5 Participants
|
1562 Participants
n=4 Participants
|
|
Age, Customized
65+
|
40 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
169 Participants
n=4 Participants
|
|
Age, Customized
Unknown
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
658 Participants
n=5 Participants
|
645 Participants
n=7 Participants
|
998 Participants
n=5 Participants
|
2301 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
542 Participants
n=5 Participants
|
556 Participants
n=7 Participants
|
801 Participants
n=5 Participants
|
1899 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
638 Participants
n=5 Participants
|
609 Participants
n=7 Participants
|
888 Participants
n=5 Participants
|
2135 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black
|
191 Participants
n=5 Participants
|
194 Participants
n=7 Participants
|
307 Participants
n=5 Participants
|
692 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
250 Participants
n=5 Participants
|
270 Participants
n=7 Participants
|
421 Participants
n=5 Participants
|
941 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
24 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
106 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian
|
18 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Multi-Race
|
76 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
252 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Education
<12
|
314 Participants
n=5 Participants
|
288 Participants
n=7 Participants
|
444 Participants
n=5 Participants
|
1046 Participants
n=4 Participants
|
|
Education
HS Diploma
|
405 Participants
n=5 Participants
|
378 Participants
n=7 Participants
|
595 Participants
n=5 Participants
|
1378 Participants
n=4 Participants
|
|
Education
Some College
|
396 Participants
n=5 Participants
|
442 Participants
n=7 Participants
|
631 Participants
n=5 Participants
|
1469 Participants
n=4 Participants
|
|
Education
BA/BS or Higher
|
84 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
304 Participants
n=4 Participants
|
|
Education
Unknown
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Language
English
|
1068 Participants
n=5 Participants
|
1049 Participants
n=7 Participants
|
1559 Participants
n=5 Participants
|
3676 Participants
n=4 Participants
|
|
Language
Spanish
|
132 Participants
n=5 Participants
|
152 Participants
n=7 Participants
|
240 Participants
n=5 Participants
|
524 Participants
n=4 Participants
|
|
Smoke Level
6-10
|
352 Participants
n=5 Participants
|
353 Participants
n=7 Participants
|
527 Participants
n=5 Participants
|
1232 Participants
n=4 Participants
|
|
Smoke Level
11+
|
848 Participants
n=5 Participants
|
848 Participants
n=7 Participants
|
1272 Participants
n=5 Participants
|
2968 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 7 months post enrollmentOutcome measures
| Measure |
Usual Care
n=1200 Participants
Subjects are not mailed nicotine patches; however, we facilitate their use by providing a certificate that can be used by the State Medicaid program and some insurance companies to obtain free patches.
|
Patch (Placebo)
n=1201 Participants
Subjects are mailed patches directly, we will mail 8 weeks of patches. Dosage depends on the number of cigarettes per day (cpd). Light smokers (6-10 cpd) will receive 6 weeks of 14 mg and 2 weeks of 7 mg patches. Heavy smokers (11+ cpd) will receive 4 weeks of 21 mg, 2 weeks of 14 mg and 2 weeks of 7 mg patches. Placebo patches will have no nicotine, but will be packaged to mimic the active patches.
|
Patch (Real)
n=1799 Participants
Subjects are mailed patches directly, we will mail 8 weeks of patches. Dosage depends on the number of cigarettes per day (cpd). Light smokers (6-10 cpd) will receive 6 weeks of 14 mg and 2 weeks of 7 mg patches. Heavy smokers (11+ cpd) will receive 4 weeks of 21 mg, 2 weeks of 14 mg and 2 weeks of 7 mg patches.
|
|---|---|---|---|
|
Number of Participants With Six-month Continuous Abstinence From Cigarettes
|
70 Participants
|
101 Participants
|
190 Participants
|
SECONDARY outcome
Timeframe: 2-months post enrollmentOutcome measures
| Measure |
Usual Care
n=1200 Participants
Subjects are not mailed nicotine patches; however, we facilitate their use by providing a certificate that can be used by the State Medicaid program and some insurance companies to obtain free patches.
|
Patch (Placebo)
n=1201 Participants
Subjects are mailed patches directly, we will mail 8 weeks of patches. Dosage depends on the number of cigarettes per day (cpd). Light smokers (6-10 cpd) will receive 6 weeks of 14 mg and 2 weeks of 7 mg patches. Heavy smokers (11+ cpd) will receive 4 weeks of 21 mg, 2 weeks of 14 mg and 2 weeks of 7 mg patches. Placebo patches will have no nicotine, but will be packaged to mimic the active patches.
|
Patch (Real)
n=1799 Participants
Subjects are mailed patches directly, we will mail 8 weeks of patches. Dosage depends on the number of cigarettes per day (cpd). Light smokers (6-10 cpd) will receive 6 weeks of 14 mg and 2 weeks of 7 mg patches. Heavy smokers (11+ cpd) will receive 4 weeks of 21 mg, 2 weeks of 14 mg and 2 weeks of 7 mg patches.
|
|---|---|---|---|
|
Number of Participants Quit for 30-days at 2-months Post Enrollment
|
136 Participants
|
173 Participants
|
334 Participants
|
Adverse Events
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Patch (Placebo)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Patch (Real)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place