Trial Outcomes & Findings for Smoking Cessation With the Nicotine Patch: A Pilot Study of Patch Messaging (NCT NCT01287377)
NCT ID: NCT01287377
Last Updated: 2020-02-13
Results Overview
At a given point in time (in this case, 2 months after program registration), quitline participants are asked whether they have used cigarettes or other forms of tobacco in the past 30 days. Those who reply that they have not used tobacco in the past 30 days are considered to have quit.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
243 participants
Primary outcome timeframe
2-months post enrollment
Results posted on
2020-02-13
Participant Flow
Recruitment period from 11/8/2010 - 1/18/2011
Participant milestones
| Measure |
Pre-Patch and Telephone Counseling
2-weeks of nicotine patches mailed directly to the subject. Clients will be encouraged to start using these patches PRIOR to their quit date.
Counseling includes a comprehensive pre-quit session (to include motivation, planning, discussion of nicotine patch use, and setting of a quit date) and up to 4 proactive follow-up calls.
Telephone Counseling: Telephone counseling has several distinguishing features, namely proactive follow up counseling calls, a manualized protocol, and relapse-sensitive scheduling. The follow-up call schedule includes a reminder call if the quit date is more than one week out, a call within 24 hours of the quit attempt, another call 4-7 days after the quit date, and another call 10-14 days after the quit date.
Nicotine Patches: Subjects are randomized into one of these pharmacotherapy interventions: direct mailing of active patches with a message to start using it on their quit date, direct mailing of active patches with a message to st
|
Post-Patch and Telephone Counseling
2-weeks of nicotine patches mailed directly to the subject. Clients are encouraged to start using their patches ON their quit date.
Counseling includes a comprehensive pre-quit session (to include motivation, planning, discussion of nicotine patch use, and setting of a quit date) and up to 4 proactive follow-up calls.
Telephone Counseling: Telephone counseling has several distinguishing features, namely proactive follow up counseling calls, a manualized protocol, and relapse-sensitive scheduling. The follow-up call schedule includes a reminder call if the quit date is more than one week out, a call within 24 hours of the quit attempt, another call 4-7 days after the quit date, and another call 10-14 days after the quit date.
Nicotine Patches: Subjects are randomized into one of these pharmacotherapy interventions: direct mailing of active patches with a message to start using it on their quit date, direct mailing of active patches with a message to start usi
|
Telephone Counseling and no Patches Sent
Counseling includes a comprehensive pre-quit session (to include motivation, planning, discussion of nicotine patch use, and setting of a quit date) and up to 4 proactive follow-up calls.
Telephone Counseling: Telephone counseling has several distinguishing features, namely proactive follow up counseling calls, a manualized protocol, and relapse-sensitive scheduling. The follow-up call schedule includes a reminder call if the quit date is more than one week out, a call within 24 hours of the quit attempt, another call 4-7 days after the quit date, and another call 10-14 days after the quit date.
|
|---|---|---|---|
|
Overall Study
STARTED
|
80
|
81
|
82
|
|
Overall Study
COMPLETED
|
80
|
81
|
82
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Smoking Cessation With the Nicotine Patch: A Pilot Study of Patch Messaging
Baseline characteristics by cohort
| Measure |
Pre-Patch and Telephone Counseling
n=80 Participants
Nicotine patches (2 weeks' worth) are mailed directly to the subject. Clients will be encouraged to start using these patches PRIOR to their quit date.
Counseling includes a comprehensive pre-quit session and up to 4 proactive follow-up calls.
Telephone Counseling: Telephone counseling has several distinguishing features, namely proactive follow up counseling calls, a manualized protocol, and relapse-sensitive scheduling. The follow-up call schedule includes a reminder call if the quit date is more than one week out, a call within 24 hours of the quit attempt, another call 4-7 days after the quit date, and another call 10-14 days after the quit date.
|
Post-Patch and Telephone Counseling
n=81 Participants
Nicotine patches (2 weeks' worth) are mailed directly to the subject. Clients are encouraged to start using their patches ON their quit date.
Counseling includes a comprehensive pre-quit session and up to 4 proactive follow-up calls.
Telephone Counseling: Telephone counseling has several distinguishing features, namely proactive follow up counseling calls, a manualized protocol, and relapse-sensitive scheduling. The follow-up call schedule includes a reminder call if the quit date is more than one week out, a call within 24 hours of the quit attempt, another call 4-7 days after the quit date, and another call 10-14 days after the quit date.
|
Telephone Counseling and no Patches Sent
n=82 Participants
Counseling includes a comprehensive pre-quit session and up to 4 proactive follow-up calls.
Telephone Counseling: Telephone counseling has several distinguishing features, namely proactive follow up counseling calls, a manualized protocol, and relapse-sensitive scheduling. The follow-up call schedule includes a reminder call if the quit date is more than one week out, a call within 24 hours of the quit attempt, another call 4-7 days after the quit date, and another call 10-14 days after the quit date.
Patches will not be mailed directly to them; however, we will facilitate their use by providing a certificate that can be used by the State Medicaid program and some other insurance companies to obtain free patches.
|
Total
n=243 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
18-24
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Age, Customized
25-44
|
35 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
104 Participants
n=4 Participants
|
|
Age, Customized
45-64
|
35 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
108 Participants
n=4 Participants
|
|
Age, Customized
65+
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
143 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
100 Participants
n=4 Participants
|
|
Education >12 Year
|
42 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
122 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 2-months post enrollmentPopulation: The number of participants analyzed is the number of participants the quitline was able to reach at 2-months post enrollment, not the number randomized into that condition
At a given point in time (in this case, 2 months after program registration), quitline participants are asked whether they have used cigarettes or other forms of tobacco in the past 30 days. Those who reply that they have not used tobacco in the past 30 days are considered to have quit.
Outcome measures
| Measure |
Pre-Patch and Telephone Counseling
n=60 Participants
2-weeks of nicotine patches mailed directly to the subject. Clients will be encouraged to start using these patches PRIOR to their quit date.
Counseling includes a comprehensive pre-quit session (to include motivation, planning, discussion of nicotine patch use, and setting of a quit date) and up to 4 proactive follow-up calls.
Telephone Counseling: Telephone counseling has several distinguishing features, namely proactive follow up counseling calls, a manualized protocol, and relapse-sensitive scheduling. The follow-up call schedule includes a reminder call if the quit date is more than one week out, a call within 24 hours of the quit attempt, another call 4-7 days after the quit date, and another call 10-14 days after the quit date.
Nicotine Patches: Subjects are randomized into one of these pharmacotherapy interventions: direct mailing of active patches with a message to start using it on their quit date, direct mailing of active patches with a message to st
|
Post-Patch and Telephone Counseling
n=65 Participants
2-weeks of nicotine patches mailed directly to the subject. Clients are encouraged to start using their patches ON their quit date.
Counseling includes a comprehensive pre-quit session (to include motivation, planning, discussion of nicotine patch use, and setting of a quit date) and up to 4 proactive follow-up calls.
Telephone Counseling: Telephone counseling has several distinguishing features, namely proactive follow up counseling calls, a manualized protocol, and relapse-sensitive scheduling. The follow-up call schedule includes a reminder call if the quit date is more than one week out, a call within 24 hours of the quit attempt, another call 4-7 days after the quit date, and another call 10-14 days after the quit date.
Nicotine Patches: Subjects are randomized into one of these pharmacotherapy interventions: direct mailing of active patches with a message to start using it on their quit date, direct mailing of active patches with a message to start usi
|
Telephone Counseling and no Patches Sent
n=60 Participants
Counseling includes a comprehensive pre-quit session (to include motivation, planning, discussion of nicotine patch use, and setting of a quit date) and up to 4 proactive follow-up calls.
Telephone Counseling: Telephone counseling has several distinguishing features, namely proactive follow up counseling calls, a manualized protocol, and relapse-sensitive scheduling. The follow-up call schedule includes a reminder call if the quit date is more than one week out, a call within 24 hours of the quit attempt, another call 4-7 days after the quit date, and another call 10-14 days after the quit date.
|
|---|---|---|---|
|
Number of Participants Who Have Not Used Tobacco in the Past 30 Days
|
18 Participants
|
26 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 2-months post enrollmentPopulation: The number of participants analyzed is the number of participants the quitline was able to reach at 2-months post enrollment, not the number randomized into that condition
A serious quit attempt is considered is a quit attempt that last more than 24 hours
Outcome measures
| Measure |
Pre-Patch and Telephone Counseling
n=60 Participants
2-weeks of nicotine patches mailed directly to the subject. Clients will be encouraged to start using these patches PRIOR to their quit date.
Counseling includes a comprehensive pre-quit session (to include motivation, planning, discussion of nicotine patch use, and setting of a quit date) and up to 4 proactive follow-up calls.
Telephone Counseling: Telephone counseling has several distinguishing features, namely proactive follow up counseling calls, a manualized protocol, and relapse-sensitive scheduling. The follow-up call schedule includes a reminder call if the quit date is more than one week out, a call within 24 hours of the quit attempt, another call 4-7 days after the quit date, and another call 10-14 days after the quit date.
Nicotine Patches: Subjects are randomized into one of these pharmacotherapy interventions: direct mailing of active patches with a message to start using it on their quit date, direct mailing of active patches with a message to st
|
Post-Patch and Telephone Counseling
n=65 Participants
2-weeks of nicotine patches mailed directly to the subject. Clients are encouraged to start using their patches ON their quit date.
Counseling includes a comprehensive pre-quit session (to include motivation, planning, discussion of nicotine patch use, and setting of a quit date) and up to 4 proactive follow-up calls.
Telephone Counseling: Telephone counseling has several distinguishing features, namely proactive follow up counseling calls, a manualized protocol, and relapse-sensitive scheduling. The follow-up call schedule includes a reminder call if the quit date is more than one week out, a call within 24 hours of the quit attempt, another call 4-7 days after the quit date, and another call 10-14 days after the quit date.
Nicotine Patches: Subjects are randomized into one of these pharmacotherapy interventions: direct mailing of active patches with a message to start using it on their quit date, direct mailing of active patches with a message to start usi
|
Telephone Counseling and no Patches Sent
n=60 Participants
Counseling includes a comprehensive pre-quit session (to include motivation, planning, discussion of nicotine patch use, and setting of a quit date) and up to 4 proactive follow-up calls.
Telephone Counseling: Telephone counseling has several distinguishing features, namely proactive follow up counseling calls, a manualized protocol, and relapse-sensitive scheduling. The follow-up call schedule includes a reminder call if the quit date is more than one week out, a call within 24 hours of the quit attempt, another call 4-7 days after the quit date, and another call 10-14 days after the quit date.
|
|---|---|---|---|
|
Number of Participants With Serious Quit Attempts
|
48 Participants
|
53 Participants
|
42 Participants
|
Adverse Events
Pre-Patch and Telephone Counseling
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Post-Patch and Telephone Counseling
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Telephone Counseling and no Patches Sent
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