Trial Outcomes & Findings for Improving the Population-Wide Effectiveness of U.S. Tobacco Cessation Quitlines (NCT NCT01087905)
NCT ID: NCT01087905
Last Updated: 2016-12-08
Results Overview
Self-reported total abstinence from any tobacco use (even a single puff) for the seven days preceding the target follow-up day.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
987 participants
Primary outcome timeframe
26 weeks after the target quit smoking date
Results posted on
2016-12-08
Participant Flow
Adult smokers who called the Wisconsin Tobacco Quit Line (WTQL) from April 1, 2010 to June 15, 2010 were invited to participate in the study; no advertising or targeted recruitment was utilized.
Participant milestones
| Measure |
2 Weeks of Nicotine Patch Only, No CMAC
Participants in this randomization group received 2 weeks of nicotine patch only and standard quitline cessation counseling consisting of 4 proactive counseling calls (but no Cognitive Medication Adherence Counseling (CMAC).
|
2 Weeks of Nicotine Patch Only Plus CMAC
Participants in this randomization group received 2 weeks of nicotine patch only and standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC).
|
2 Weeks of Nicotine Patch+Nicotine Gum , No CMAC
Participants in this randomization group received 2 weeks of nicotine patch plus nicotine gum and standard quitline cessation counseling consisting of 4 proactive counseling calls (but no Cognitive Medication Adherence Counseling (CMAC).
|
2 Weeks of Nicotine Patch+Nicotine Gum and CMAC
Participants in this randomization group received 2 weeks of nicotine patch plus nicotine gum and standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC).
|
6 Weeks of Nicotine Patch Only, No CMAC
Participants in this randomization group received 6 weeks of nicotine patch only and standard quitline cessation counseling consisting of 4 proactive counseling calls (but no Cognitive Medication Adherence Counseling (CMAC).
|
6 Weeks of Nicotine Patch Only Plus CMAC
Participants in this randomization group received 6 weeks of nicotine patch only and standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC).
|
6 Weeks of Nicotine Patch+Nicotine Gum , No CMAC
Participants in this randomization group received 6 weeks of nicotine patch plus nicotine gum and standard quitline cessation counseling consisting of 4 proactive counseling calls (but no Cognitive Medication Adherence Counseling (CMAC).
|
6 Weeks of Nicotine Patch+Nicotine Gum and CMAC
Participants in this randomization group received 6 weeks of nicotine patch plus nicotine gum and standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC).
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
119
|
126
|
123
|
122
|
122
|
127
|
121
|
127
|
|
Overall Study
COMPLETED
|
90
|
94
|
101
|
86
|
91
|
99
|
98
|
98
|
|
Overall Study
NOT COMPLETED
|
29
|
32
|
22
|
36
|
31
|
28
|
23
|
29
|
Reasons for withdrawal
| Measure |
2 Weeks of Nicotine Patch Only, No CMAC
Participants in this randomization group received 2 weeks of nicotine patch only and standard quitline cessation counseling consisting of 4 proactive counseling calls (but no Cognitive Medication Adherence Counseling (CMAC).
|
2 Weeks of Nicotine Patch Only Plus CMAC
Participants in this randomization group received 2 weeks of nicotine patch only and standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC).
|
2 Weeks of Nicotine Patch+Nicotine Gum , No CMAC
Participants in this randomization group received 2 weeks of nicotine patch plus nicotine gum and standard quitline cessation counseling consisting of 4 proactive counseling calls (but no Cognitive Medication Adherence Counseling (CMAC).
|
2 Weeks of Nicotine Patch+Nicotine Gum and CMAC
Participants in this randomization group received 2 weeks of nicotine patch plus nicotine gum and standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC).
|
6 Weeks of Nicotine Patch Only, No CMAC
Participants in this randomization group received 6 weeks of nicotine patch only and standard quitline cessation counseling consisting of 4 proactive counseling calls (but no Cognitive Medication Adherence Counseling (CMAC).
|
6 Weeks of Nicotine Patch Only Plus CMAC
Participants in this randomization group received 6 weeks of nicotine patch only and standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC).
|
6 Weeks of Nicotine Patch+Nicotine Gum , No CMAC
Participants in this randomization group received 6 weeks of nicotine patch plus nicotine gum and standard quitline cessation counseling consisting of 4 proactive counseling calls (but no Cognitive Medication Adherence Counseling (CMAC).
|
6 Weeks of Nicotine Patch+Nicotine Gum and CMAC
Participants in this randomization group received 6 weeks of nicotine patch plus nicotine gum and standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC).
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
24
|
28
|
18
|
31
|
27
|
25
|
20
|
24
|
|
Overall Study
Withdrawal by Subject
|
5
|
4
|
4
|
5
|
4
|
3
|
3
|
5
|
Baseline Characteristics
Improving the Population-Wide Effectiveness of U.S. Tobacco Cessation Quitlines
Baseline characteristics by cohort
| Measure |
2 Weeks of Nicotine Patch Only, No CMAC
n=119 Participants
Participants in this randomization group received 2 weeks of nicotine patch only and standard quitline cessation counseling consisting of 4 proactive counseling calls (but no Cognitive Medication Adherence Counseling (CMAC).
|
2 Weeks of Nicotine Patch Only Plus CMAC
n=126 Participants
Participants in this randomization group received 2 weeks of nicotine patch only and standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC).
|
2 Weeks of Nicotine Patch+Nicotine Gum , No CMAC
n=123 Participants
Participants in this randomization group received 2 weeks of nicotine patch plus nicotine gum and standard quitline cessation counseling consisting of 4 proactive counseling calls (but no Cognitive Medication Adherence Counseling (CMAC).
|
2 Weeks of Nicotine Patch+Nicotine Gum and CMAC
n=122 Participants
Participants in this randomization group received 2 weeks of nicotine patch plus nicotine gum and standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC).
|
6 Weeks of Nicotine Patch Only, No CMAC
n=122 Participants
Participants in this randomization group received 6 weeks of nicotine patch only and standard quitline cessation counseling consisting of 4 proactive counseling calls (but no Cognitive Medication Adherence Counseling (CMAC).
|
6 Weeks of Nicotine Patch Only Plus CMAC
n=127 Participants
Participants in this randomization group received 6 weeks of nicotine patch only and standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC).
|
6 Weeks of Nicotine Patch+Nicotine Gum , No CMAC
n=121 Participants
Participants in this randomization group received 6 weeks of nicotine patch plus nicotine gum and standard quitline cessation counseling consisting of 4 proactive counseling calls (but no Cognitive Medication Adherence Counseling (CMAC).
|
6 Weeks of Nicotine Patch+Nicotine Gum and CMAC
n=127 Participants
Participants in this randomization group received 6 weeks of nicotine patch plus nicotine gum and standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC).
|
Total
n=987 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
2 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
115 Participants
n=93 Participants
|
119 Participants
n=4 Participants
|
121 Participants
n=27 Participants
|
119 Participants
n=483 Participants
|
116 Participants
n=36 Participants
|
119 Participants
n=10 Participants
|
114 Participants
n=115 Participants
|
123 Participants
n=40 Participants
|
946 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
8 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
4 Participants
n=40 Participants
|
39 Participants
n=8 Participants
|
|
Age, Continuous
|
42.33 years
STANDARD_DEVIATION 12.99 • n=93 Participants
|
43.35 years
STANDARD_DEVIATION 12.61 • n=4 Participants
|
41.39 years
STANDARD_DEVIATION 11.24 • n=27 Participants
|
40.84 years
STANDARD_DEVIATION 11.96 • n=483 Participants
|
41.74 years
STANDARD_DEVIATION 14.19 • n=36 Participants
|
43.18 years
STANDARD_DEVIATION 13.627 • n=10 Participants
|
42.61 years
STANDARD_DEVIATION 13.51 • n=115 Participants
|
40.03 years
STANDARD_DEVIATION 13.31 • n=40 Participants
|
41.93 years
STANDARD_DEVIATION 12.96 • n=8 Participants
|
|
Gender
Female
|
71 Participants
n=93 Participants
|
65 Participants
n=4 Participants
|
63 Participants
n=27 Participants
|
70 Participants
n=483 Participants
|
75 Participants
n=36 Participants
|
72 Participants
n=10 Participants
|
74 Participants
n=115 Participants
|
79 Participants
n=40 Participants
|
569 Participants
n=8 Participants
|
|
Gender
Male
|
48 Participants
n=93 Participants
|
61 Participants
n=4 Participants
|
60 Participants
n=27 Participants
|
52 Participants
n=483 Participants
|
47 Participants
n=36 Participants
|
55 Participants
n=10 Participants
|
47 Participants
n=115 Participants
|
48 Participants
n=40 Participants
|
418 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
119 participants
n=93 Participants
|
126 participants
n=4 Participants
|
123 participants
n=27 Participants
|
122 participants
n=483 Participants
|
122 participants
n=36 Participants
|
127 participants
n=10 Participants
|
121 participants
n=115 Participants
|
127 participants
n=40 Participants
|
987 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 26 weeks after the target quit smoking datePopulation: The study was originally powered to detect at least a 6.4% increase in the abstinence rate due to an enhanced intervention (e.g., 6 wks NRT); this effect size was based on prior quitline studies; we predicted that abstinence rates at 6 months would be approximately 12% in a standard intervention vs. 18.4% in an enhanced intervention.
Self-reported total abstinence from any tobacco use (even a single puff) for the seven days preceding the target follow-up day.
Outcome measures
| Measure |
Two Weeks of Nicotine Replacement Therapy (NRT)
n=490 Participants
Participants in this intervention group received a two-week supply of Nicotine Replacement Therapy (NRT). This intervention is considered to be the standard intervention in terms of duration of NRT; it will be compared to the enhanced NRT duration intervention which is six weeks of NRT. Approximately half the total sample was randomized to the standard intervention (two weeks of NRT) and half to the enhanced intervention (six weeks of NRT).
|
Six Weeks of Nicotine Replacement Therapy (NRT)
n=497 Participants
Participants in this intervention group received a six-week supply of Nicotine Replacement Therapy (NRT). This intervention is considered to be the enhanced intervention in terms of duration of NRT; it will be compared to the standard NRT duration intervention which is two weeks of NRT. Approximately half the total sample was randomized to the standard intervention (two weeks of NRT) and half to the enhanced intervention (six weeks of NRT).
|
NRT Monotherapy (Nicotine Patch Only)
n=494 Participants
Participants in this intervention group received a single Nicotine Replacement Therapy (NRT) consisting of the Nicotine Patch only. This intervention is considered to be the standard intervention in terms of type of NRT; it will be compared to the enhanced NRT type intervention which is combination NRT consisting of Nicotine Patch plus Nicotine Gum (Combo NRT). Approximately half the total sample was randomized to the standard intervention (Nicotine Patch Only) and half to the enhanced intervention (Nicotine Patch plus Nicotine Gum).
|
NRT Combination Therapy (Nicotine Patch Plus Nicotine Gum)
n=493 Participants
Participants in this intervention group received Combination Nicotine Replacement Therapy (NRT) consisting of the Nicotine Patch plus Nicotine Gum. This intervention is considered to be the enhanced intervention in terms of type of NRT; it will be compared to the standard NRT type intervention which is NRT Monotherapy consisting of the Nicotine Patch Only. Approximately half the total sample was randomized to the standard intervention (Nicotine Patch Only) and half to the enhanced intervention (Nicotine Patch plus Nicotine Gum).
|
Standard Cessation Counseling (No CMAC)
n=485 Participants
Participants in this intervention group received standard quitline cessation counseling consisting of 4 proactive counseling calls. This intervention is considered to be the standard intervention in terms of cessation counseling; it will be compared to the enhanced cessation counseling intervention which consists of Standard Cessation Counseling plus Cognitive Medication Adherence Counseling (CMAC). Approximately half the total sample was randomized to the standard intervention (Standard Cessation Counseling, No CMAC) and half to the enhanced intervention (Standard Cessation Counseling plus CMAC).
|
Standard Cessation Counseling Plus CMAC)
n=502 Participants
Participants in this intervention group received standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC). This intervention is considered to be the enhanced intervention in terms of cessation counseling; it will be compared to the standard cessation counseling intervention which consists of Standard Cessation Counseling only (no CMAC). Approximately half the total sample was randomized to the standard intervention (Standard Cessation Counseling, No CMAC) and half to the enhanced intervention (Standard Cessation Counseling plus CMAC).
|
|---|---|---|---|---|---|---|
|
7-Day Point Prevalence Abstinence From Smoking by Intervention
|
43.3 Percentage of participants not smoking
|
48.9 Percentage of participants not smoking
|
42.3 Percentage of participants not smoking
|
49.9 Percentage of participants not smoking
|
47.6 Percentage of participants not smoking
|
44.6 Percentage of participants not smoking
|
PRIMARY outcome
Timeframe: 26 weeks after the target quit smoking datePopulation: The study was originally powered to detect at least a 6.4% increase in the abstinence rate due to an enhanced intervention (e.g., 6 wks NRT); this effect size was based on prior quitline studies; we predicted that abstinence rates at 6 months would be approximately 12% in a standard intervention vs. 18.4% in an enhanced intervention.
Self-reported total abstinence from any tobacco use (even a single puff) for the seven days preceding the target follow-up day.
Outcome measures
| Measure |
Two Weeks of Nicotine Replacement Therapy (NRT)
n=245 Participants
Participants in this intervention group received a two-week supply of Nicotine Replacement Therapy (NRT). This intervention is considered to be the standard intervention in terms of duration of NRT; it will be compared to the enhanced NRT duration intervention which is six weeks of NRT. Approximately half the total sample was randomized to the standard intervention (two weeks of NRT) and half to the enhanced intervention (six weeks of NRT).
|
Six Weeks of Nicotine Replacement Therapy (NRT)
n=245 Participants
Participants in this intervention group received a six-week supply of Nicotine Replacement Therapy (NRT). This intervention is considered to be the enhanced intervention in terms of duration of NRT; it will be compared to the standard NRT duration intervention which is two weeks of NRT. Approximately half the total sample was randomized to the standard intervention (two weeks of NRT) and half to the enhanced intervention (six weeks of NRT).
|
NRT Monotherapy (Nicotine Patch Only)
n=249 Participants
Participants in this intervention group received a single Nicotine Replacement Therapy (NRT) consisting of the Nicotine Patch only. This intervention is considered to be the standard intervention in terms of type of NRT; it will be compared to the enhanced NRT type intervention which is combination NRT consisting of Nicotine Patch plus Nicotine Gum (Combo NRT). Approximately half the total sample was randomized to the standard intervention (Nicotine Patch Only) and half to the enhanced intervention (Nicotine Patch plus Nicotine Gum).
|
NRT Combination Therapy (Nicotine Patch Plus Nicotine Gum)
n=248 Participants
Participants in this intervention group received Combination Nicotine Replacement Therapy (NRT) consisting of the Nicotine Patch plus Nicotine Gum. This intervention is considered to be the enhanced intervention in terms of type of NRT; it will be compared to the standard NRT type intervention which is NRT Monotherapy consisting of the Nicotine Patch Only. Approximately half the total sample was randomized to the standard intervention (Nicotine Patch Only) and half to the enhanced intervention (Nicotine Patch plus Nicotine Gum).
|
Standard Cessation Counseling (No CMAC)
Participants in this intervention group received standard quitline cessation counseling consisting of 4 proactive counseling calls. This intervention is considered to be the standard intervention in terms of cessation counseling; it will be compared to the enhanced cessation counseling intervention which consists of Standard Cessation Counseling plus Cognitive Medication Adherence Counseling (CMAC). Approximately half the total sample was randomized to the standard intervention (Standard Cessation Counseling, No CMAC) and half to the enhanced intervention (Standard Cessation Counseling plus CMAC).
|
Standard Cessation Counseling Plus CMAC)
Participants in this intervention group received standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC). This intervention is considered to be the enhanced intervention in terms of cessation counseling; it will be compared to the standard cessation counseling intervention which consists of Standard Cessation Counseling only (no CMAC). Approximately half the total sample was randomized to the standard intervention (Standard Cessation Counseling, No CMAC) and half to the enhanced intervention (Standard Cessation Counseling plus CMAC).
|
|---|---|---|---|---|---|---|
|
7-Day Point Prevalence Abstinence From Smoking by Nicotine Replacement Therapy (NRT) Group
|
38.4 Percentage of participants not smoking
|
48.2 Percentage of participants not smoking
|
46.2 Percentage of participants not smoking
|
51.6 Percentage of participants not smoking
|
—
|
—
|
SECONDARY outcome
Timeframe: 26 weeks after the target quit smoking datePopulation: No "a priori" power analysis was conducted for this secondary outcome.
For cost analyses, we computed the costs of intervention per caller, the cost per quit based on the 6-month ITT 7-day PPA, and the incremental cost-effectiveness ratio (ICER. Intervention costs included direct costs associated with registration, provision of NRT and counseling (standard and MAC), and mailing of a quit guide (all participants) and a MAC information sheet (MAC participants only). Facility space, supplies, and physician supervision time were included in the call costs; research-related costs were excluded. ICER ratio is a measure of the added cost per added quit for two treatments. ICER was computed as the cost difference between the least intensive treatment group (2 weeks of nicotine patch only) and a more intensive comparison group divided by the difference in the quit rates of the two groups being compared; e.g., the ICER for the group that received 2 weeks of nicotine patch and nicotine gum = (213-178)/(.482-.384) = $357.
Outcome measures
| Measure |
Two Weeks of Nicotine Replacement Therapy (NRT)
n=245 Participants
Participants in this intervention group received a two-week supply of Nicotine Replacement Therapy (NRT). This intervention is considered to be the standard intervention in terms of duration of NRT; it will be compared to the enhanced NRT duration intervention which is six weeks of NRT. Approximately half the total sample was randomized to the standard intervention (two weeks of NRT) and half to the enhanced intervention (six weeks of NRT).
|
Six Weeks of Nicotine Replacement Therapy (NRT)
n=245 Participants
Participants in this intervention group received a six-week supply of Nicotine Replacement Therapy (NRT). This intervention is considered to be the enhanced intervention in terms of duration of NRT; it will be compared to the standard NRT duration intervention which is two weeks of NRT. Approximately half the total sample was randomized to the standard intervention (two weeks of NRT) and half to the enhanced intervention (six weeks of NRT).
|
NRT Monotherapy (Nicotine Patch Only)
n=249 Participants
Participants in this intervention group received a single Nicotine Replacement Therapy (NRT) consisting of the Nicotine Patch only. This intervention is considered to be the standard intervention in terms of type of NRT; it will be compared to the enhanced NRT type intervention which is combination NRT consisting of Nicotine Patch plus Nicotine Gum (Combo NRT). Approximately half the total sample was randomized to the standard intervention (Nicotine Patch Only) and half to the enhanced intervention (Nicotine Patch plus Nicotine Gum).
|
NRT Combination Therapy (Nicotine Patch Plus Nicotine Gum)
n=248 Participants
Participants in this intervention group received Combination Nicotine Replacement Therapy (NRT) consisting of the Nicotine Patch plus Nicotine Gum. This intervention is considered to be the enhanced intervention in terms of type of NRT; it will be compared to the standard NRT type intervention which is NRT Monotherapy consisting of the Nicotine Patch Only. Approximately half the total sample was randomized to the standard intervention (Nicotine Patch Only) and half to the enhanced intervention (Nicotine Patch plus Nicotine Gum).
|
Standard Cessation Counseling (No CMAC)
Participants in this intervention group received standard quitline cessation counseling consisting of 4 proactive counseling calls. This intervention is considered to be the standard intervention in terms of cessation counseling; it will be compared to the enhanced cessation counseling intervention which consists of Standard Cessation Counseling plus Cognitive Medication Adherence Counseling (CMAC). Approximately half the total sample was randomized to the standard intervention (Standard Cessation Counseling, No CMAC) and half to the enhanced intervention (Standard Cessation Counseling plus CMAC).
|
Standard Cessation Counseling Plus CMAC)
Participants in this intervention group received standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC). This intervention is considered to be the enhanced intervention in terms of cessation counseling; it will be compared to the standard cessation counseling intervention which consists of Standard Cessation Counseling only (no CMAC). Approximately half the total sample was randomized to the standard intervention (Standard Cessation Counseling, No CMAC) and half to the enhanced intervention (Standard Cessation Counseling plus CMAC).
|
|---|---|---|---|---|---|---|
|
Incremental Cost-Effectiveness Ratio for 7-Day Point Prevalence Abstinence From Smoking at 26 Weeks Post-Quit by Nicotine Replacement Therapy (NRT) Group
|
94 U.S. Dollars
|
118 U.S. Dollars
|
115 U.S. Dollars
|
128 U.S. Dollars
|
—
|
—
|
Adverse Events
Two Weeks of Nicotine Patch Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Two Weeks of Combination NRT (Nicotine Patch + Nicotine Gum)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Six Weeks of Nicotine Patch Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Six Weeks of Combination NRT (Nicotine Patch + Nicotine Gum)
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
Stevens S. Smith, Ph.D.
University of Wisconsin School of Medicine and Public Health
Phone: 608-262-7563
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place