Trial Outcomes & Findings for A Comparative Effectiveness RCT of Optimized Cessation Treatments (NCT NCT02301403)
NCT ID: NCT02301403
Last Updated: 2020-05-13
Results Overview
The outcome measure consists of the number of participants reporting abstinence from smoking at 6 months that is biochemically confirmed (exhaled carbon monoxide \< 6 parts per million).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
623 participants
Primary outcome timeframe
6 months post treatment
Results posted on
2020-05-13
Participant Flow
Participants were patients from seven primary care clinics within two Wisconsin healthcare systems. Smokers who expressed interest in quitting smoking during a clinic visit were referred via the electronic health record (EHR) to the research study. Other smokers from these clinics were recruited via mailings and EHR messaging.
Primary care patients who passed the phone screen were invited to attend a study visit at their referring clinic to learn more about the study, have eligibility confirmed, and provide written informed consent. No enrolled participants were excluded from the study prior to assignment to groups.
Participant milestones
| Measure |
Modern Usual Care
Participants assigned to the M-UC will receive 8 weeks of nicotine patch, a single brief, in-person counseling session, a faxed referral to the Wisconsin Tobacco Quit Line (WTQL), and will be signed up for either the QUITNOW app or the Web Coach (both provided by Alere Wellbeing, the vendor that provides the WTQL services).
Nicotine patch: 8 weeks of nicotine patch
in-person counseling and quitline counseling: a single brief, in-person counseling session plus a faxed referral to the Wisconsin Tobacco Quit Line (WTQL), for counseling, including the QUITNOW app and the Website
|
Abstinence-Optimized Cessation Treatment
There are 5 intervention components to include in the AOCT package: 1) Preparation Nicotine Mini-Lozenges; 2) 26-week postquit Combination NRT (nicotine patch + nicotine mini-lozenges); 3) Intensive In-Person Cessation Counseling; 4) Extended Maintenance Counseling Calls; and 5) Automated Adherence Calls.
Preparation Nicotine Mini-Lozenges: Nicotine lozenge prior to attempting to quit smoking
Combination NRT (nicotine patch + nicotine mini-lozenges): 26 weeks of combination NRT as part of a quit smoking attempt
Intensive In-Person Cessation Counseling: three 20-min In-person Cessation Counseling sessions
Extended Maintenance Counseling Calls: 8 Maintenance-phase smoking cessation counseling sessions
Automated Adherence Calls: 11 brief, automated calls reminding them to use their medications properly
|
|---|---|---|
|
Overall Study
STARTED
|
315
|
308
|
|
Overall Study
COMPLETED
|
287
|
267
|
|
Overall Study
NOT COMPLETED
|
28
|
41
|
Reasons for withdrawal
| Measure |
Modern Usual Care
Participants assigned to the M-UC will receive 8 weeks of nicotine patch, a single brief, in-person counseling session, a faxed referral to the Wisconsin Tobacco Quit Line (WTQL), and will be signed up for either the QUITNOW app or the Web Coach (both provided by Alere Wellbeing, the vendor that provides the WTQL services).
Nicotine patch: 8 weeks of nicotine patch
in-person counseling and quitline counseling: a single brief, in-person counseling session plus a faxed referral to the Wisconsin Tobacco Quit Line (WTQL), for counseling, including the QUITNOW app and the Website
|
Abstinence-Optimized Cessation Treatment
There are 5 intervention components to include in the AOCT package: 1) Preparation Nicotine Mini-Lozenges; 2) 26-week postquit Combination NRT (nicotine patch + nicotine mini-lozenges); 3) Intensive In-Person Cessation Counseling; 4) Extended Maintenance Counseling Calls; and 5) Automated Adherence Calls.
Preparation Nicotine Mini-Lozenges: Nicotine lozenge prior to attempting to quit smoking
Combination NRT (nicotine patch + nicotine mini-lozenges): 26 weeks of combination NRT as part of a quit smoking attempt
Intensive In-Person Cessation Counseling: three 20-min In-person Cessation Counseling sessions
Extended Maintenance Counseling Calls: 8 Maintenance-phase smoking cessation counseling sessions
Automated Adherence Calls: 11 brief, automated calls reminding them to use their medications properly
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
28
|
41
|
Baseline Characteristics
A Comparative Effectiveness RCT of Optimized Cessation Treatments
Baseline characteristics by cohort
| Measure |
Modern Usual Care
n=315 Participants
Participants assigned to the M-UC will receive 8 weeks of nicotine patch, a single brief, in-person counseling session, a faxed referral to the Wisconsin Tobacco Quit Line (WTQL), and will be signed up for either the QUITNOW app or the Web Coach (both provided by Alere Wellbeing, the vendor that provides the WTQL services).
Nicotine patch: 8 weeks of nicotine patch
in-person counseling and quitline counseling: a single brief, in-person counseling session plus a faxed referral to the Wisconsin Tobacco Quit Line (WTQL), for counseling, including the QUITNOW app and the Website
|
Abstinence-Optimized Cessation Treatment
n=308 Participants
There are 5 intervention components to include in the AOCT package: 1) Preparation Nicotine Mini-Lozenges; 2) 26-week postquit Combination NRT (nicotine patch + nicotine mini-lozenges); 3) Intensive In-Person Cessation Counseling; 4) Extended Maintenance Counseling Calls; and 5) Automated Adherence Calls.
Preparation Nicotine Mini-Lozenges: Nicotine lozenge prior to attempting to quit smoking
Combination NRT (nicotine patch + nicotine mini-lozenges): 26 weeks of combination NRT as part of a quit smoking attempt
Intensive In-Person Cessation Counseling: three 20-min In-person Cessation Counseling sessions
Extended Maintenance Counseling Calls: 8 Maintenance-phase smoking cessation counseling sessions
Automated Adherence Calls: 11 brief, automated calls reminding them to use their medications properly
|
Total
n=623 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.4 years
STANDARD_DEVIATION 12.9 • n=93 Participants
|
50.0 years
STANDARD_DEVIATION 12.5 • n=4 Participants
|
49.7 years
STANDARD_DEVIATION 12.7 • n=27 Participants
|
|
Sex: Female, Male
Female
|
184 Participants
n=93 Participants
|
173 Participants
n=4 Participants
|
357 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
131 Participants
n=93 Participants
|
135 Participants
n=4 Participants
|
266 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
92 Participants
n=93 Participants
|
69 Participants
n=4 Participants
|
161 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
211 Participants
n=93 Participants
|
220 Participants
n=4 Participants
|
431 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
315 participants
n=93 Participants
|
308 participants
n=4 Participants
|
623 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 6 months post treatmentPopulation: Adult smokers interested in quitting smoking who met inclusion and exclusion criteria.
The outcome measure consists of the number of participants reporting abstinence from smoking at 6 months that is biochemically confirmed (exhaled carbon monoxide \< 6 parts per million).
Outcome measures
| Measure |
Modern Usual Care
n=315 Participants
Participants assigned to the M-UC will receive 8 weeks of nicotine patch, a single brief, in-person counseling session, a faxed referral to the Wisconsin Tobacco Quit Line (WTQL), and will be signed up for either the QUITNOW app or the Web Coach (both provided by Alere Wellbeing, the vendor that provides the WTQL services).
Nicotine patch: 8 weeks of nicotine patch
in-person counseling and quitline counseling: a single brief, in-person counseling session plus a faxed referral to the Wisconsin Tobacco Quit Line (WTQL), for counseling, including the QUITNOW app and the Website
|
Abstinence-Optimized Cessation Treatment
n=308 Participants
There are 5 intervention components to include in the AOCT package: 1) Preparation Nicotine Mini-Lozenges; 2) 26-week postquit Combination NRT (nicotine patch + nicotine mini-lozenges); 3) Intensive In-Person Cessation Counseling; 4) Extended Maintenance Counseling Calls; and 5) Automated Adherence Calls.
Preparation Nicotine Mini-Lozenges: Nicotine lozenge prior to attempting to quit smoking
Combination NRT (nicotine patch + nicotine mini-lozenges): 26 weeks of combination NRT as part of a quit smoking attempt
Intensive In-Person Cessation Counseling: three 20-min In-person Cessation Counseling sessions
Extended Maintenance Counseling Calls: 8 Maintenance-phase smoking cessation counseling sessions
Automated Adherence Calls: 11 brief, automated calls reminding them to use their medications properly
|
|---|---|---|
|
Number of Participants With Abstinence From Smoking
|
19 Participants
|
49 Participants
|
Adverse Events
Modern Usual Care
Serious events: 0 serious events
Other events: 66 other events
Deaths: 0 deaths
Abstinence-Optimized Cessation Treatment
Serious events: 0 serious events
Other events: 139 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Modern Usual Care
n=315 participants at risk
Participants assigned to the M-UC will receive 8 weeks of nicotine patch, a single brief, in-person counseling session, a faxed referral to the Wisconsin Tobacco Quit Line (WTQL), and will be signed up for either the QUITNOW app or the Web Coach (both provided by Alere Wellbeing, the vendor that provides the WTQL services).
Nicotine patch: 8 weeks of nicotine patch
in-person counseling and quitline counseling: a single brief, in-person counseling session plus a faxed referral to the Wisconsin Tobacco Quit Line (WTQL), for counseling, including the QUITNOW app and the Website
|
Abstinence-Optimized Cessation Treatment
n=308 participants at risk
There are 5 intervention components to include in the AOCT package: 1) Preparation Nicotine Mini-Lozenges; 2) 26-week postquit Combination NRT (nicotine patch + nicotine mini-lozenges); 3) Intensive In-Person Cessation Counseling; 4) Extended Maintenance Counseling Calls; and 5) Automated Adherence Calls.
Preparation Nicotine Mini-Lozenges: Nicotine lozenge prior to attempting to quit smoking
Combination NRT (nicotine patch + nicotine mini-lozenges): 26 weeks of combination NRT as part of a quit smoking attempt
Intensive In-Person Cessation Counseling: three 20-min In-person Cessation Counseling sessions
Extended Maintenance Counseling Calls: 8 Maintenance-phase smoking cessation counseling sessions
Automated Adherence Calls: 11 brief, automated calls reminding them to use their medications properly
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
2.9%
9/315 • Number of events 9 • Adverse event data was collected for participants using the nicotine patch during 8 weeks of active patch treatment. Adverse event data was collected for participants using the nicotine patch and nicotine mini-lozenge during 26 weeks of active use of these 2 medications post-quit.
Adverse events (AEs) and serious AEs (SAEs) were assessed with the question "Since your last contact with us, have there been any changes in your medical condition or health?" * For each nicotine-medication-related symptom reported, severity was assessed and whether the symptom has resolved. * For any non-nicotine-medication-related symptoms that are reported as a concern, participants were advised to contact their primary care provider in the clinic as per IRB approval.
|
12.3%
38/308 • Number of events 38 • Adverse event data was collected for participants using the nicotine patch during 8 weeks of active patch treatment. Adverse event data was collected for participants using the nicotine patch and nicotine mini-lozenge during 26 weeks of active use of these 2 medications post-quit.
Adverse events (AEs) and serious AEs (SAEs) were assessed with the question "Since your last contact with us, have there been any changes in your medical condition or health?" * For each nicotine-medication-related symptom reported, severity was assessed and whether the symptom has resolved. * For any non-nicotine-medication-related symptoms that are reported as a concern, participants were advised to contact their primary care provider in the clinic as per IRB approval.
|
|
Nervous system disorders
Headache
|
4.8%
15/315 • Number of events 15 • Adverse event data was collected for participants using the nicotine patch during 8 weeks of active patch treatment. Adverse event data was collected for participants using the nicotine patch and nicotine mini-lozenge during 26 weeks of active use of these 2 medications post-quit.
Adverse events (AEs) and serious AEs (SAEs) were assessed with the question "Since your last contact with us, have there been any changes in your medical condition or health?" * For each nicotine-medication-related symptom reported, severity was assessed and whether the symptom has resolved. * For any non-nicotine-medication-related symptoms that are reported as a concern, participants were advised to contact their primary care provider in the clinic as per IRB approval.
|
4.9%
15/308 • Number of events 15 • Adverse event data was collected for participants using the nicotine patch during 8 weeks of active patch treatment. Adverse event data was collected for participants using the nicotine patch and nicotine mini-lozenge during 26 weeks of active use of these 2 medications post-quit.
Adverse events (AEs) and serious AEs (SAEs) were assessed with the question "Since your last contact with us, have there been any changes in your medical condition or health?" * For each nicotine-medication-related symptom reported, severity was assessed and whether the symptom has resolved. * For any non-nicotine-medication-related symptoms that are reported as a concern, participants were advised to contact their primary care provider in the clinic as per IRB approval.
|
|
Immune system disorders
Itching or Hives
|
7.0%
22/315 • Number of events 22 • Adverse event data was collected for participants using the nicotine patch during 8 weeks of active patch treatment. Adverse event data was collected for participants using the nicotine patch and nicotine mini-lozenge during 26 weeks of active use of these 2 medications post-quit.
Adverse events (AEs) and serious AEs (SAEs) were assessed with the question "Since your last contact with us, have there been any changes in your medical condition or health?" * For each nicotine-medication-related symptom reported, severity was assessed and whether the symptom has resolved. * For any non-nicotine-medication-related symptoms that are reported as a concern, participants were advised to contact their primary care provider in the clinic as per IRB approval.
|
7.5%
23/308 • Number of events 23 • Adverse event data was collected for participants using the nicotine patch during 8 weeks of active patch treatment. Adverse event data was collected for participants using the nicotine patch and nicotine mini-lozenge during 26 weeks of active use of these 2 medications post-quit.
Adverse events (AEs) and serious AEs (SAEs) were assessed with the question "Since your last contact with us, have there been any changes in your medical condition or health?" * For each nicotine-medication-related symptom reported, severity was assessed and whether the symptom has resolved. * For any non-nicotine-medication-related symptoms that are reported as a concern, participants were advised to contact their primary care provider in the clinic as per IRB approval.
|
|
General disorders
Sore Throat
|
0.32%
1/315 • Number of events 1 • Adverse event data was collected for participants using the nicotine patch during 8 weeks of active patch treatment. Adverse event data was collected for participants using the nicotine patch and nicotine mini-lozenge during 26 weeks of active use of these 2 medications post-quit.
Adverse events (AEs) and serious AEs (SAEs) were assessed with the question "Since your last contact with us, have there been any changes in your medical condition or health?" * For each nicotine-medication-related symptom reported, severity was assessed and whether the symptom has resolved. * For any non-nicotine-medication-related symptoms that are reported as a concern, participants were advised to contact their primary care provider in the clinic as per IRB approval.
|
4.9%
15/308 • Number of events 15 • Adverse event data was collected for participants using the nicotine patch during 8 weeks of active patch treatment. Adverse event data was collected for participants using the nicotine patch and nicotine mini-lozenge during 26 weeks of active use of these 2 medications post-quit.
Adverse events (AEs) and serious AEs (SAEs) were assessed with the question "Since your last contact with us, have there been any changes in your medical condition or health?" * For each nicotine-medication-related symptom reported, severity was assessed and whether the symptom has resolved. * For any non-nicotine-medication-related symptoms that are reported as a concern, participants were advised to contact their primary care provider in the clinic as per IRB approval.
|
|
Skin and subcutaneous tissue disorders
Skin rash
|
5.7%
18/315 • Number of events 18 • Adverse event data was collected for participants using the nicotine patch during 8 weeks of active patch treatment. Adverse event data was collected for participants using the nicotine patch and nicotine mini-lozenge during 26 weeks of active use of these 2 medications post-quit.
Adverse events (AEs) and serious AEs (SAEs) were assessed with the question "Since your last contact with us, have there been any changes in your medical condition or health?" * For each nicotine-medication-related symptom reported, severity was assessed and whether the symptom has resolved. * For any non-nicotine-medication-related symptoms that are reported as a concern, participants were advised to contact their primary care provider in the clinic as per IRB approval.
|
10.7%
33/308 • Number of events 33 • Adverse event data was collected for participants using the nicotine patch during 8 weeks of active patch treatment. Adverse event data was collected for participants using the nicotine patch and nicotine mini-lozenge during 26 weeks of active use of these 2 medications post-quit.
Adverse events (AEs) and serious AEs (SAEs) were assessed with the question "Since your last contact with us, have there been any changes in your medical condition or health?" * For each nicotine-medication-related symptom reported, severity was assessed and whether the symptom has resolved. * For any non-nicotine-medication-related symptoms that are reported as a concern, participants were advised to contact their primary care provider in the clinic as per IRB approval.
|
|
Psychiatric disorders
Insomnia
|
2.2%
7/315 • Number of events 7 • Adverse event data was collected for participants using the nicotine patch during 8 weeks of active patch treatment. Adverse event data was collected for participants using the nicotine patch and nicotine mini-lozenge during 26 weeks of active use of these 2 medications post-quit.
Adverse events (AEs) and serious AEs (SAEs) were assessed with the question "Since your last contact with us, have there been any changes in your medical condition or health?" * For each nicotine-medication-related symptom reported, severity was assessed and whether the symptom has resolved. * For any non-nicotine-medication-related symptoms that are reported as a concern, participants were advised to contact their primary care provider in the clinic as per IRB approval.
|
6.2%
19/308 • Number of events 19 • Adverse event data was collected for participants using the nicotine patch during 8 weeks of active patch treatment. Adverse event data was collected for participants using the nicotine patch and nicotine mini-lozenge during 26 weeks of active use of these 2 medications post-quit.
Adverse events (AEs) and serious AEs (SAEs) were assessed with the question "Since your last contact with us, have there been any changes in your medical condition or health?" * For each nicotine-medication-related symptom reported, severity was assessed and whether the symptom has resolved. * For any non-nicotine-medication-related symptoms that are reported as a concern, participants were advised to contact their primary care provider in the clinic as per IRB approval.
|
|
Psychiatric disorders
Vivid Dreams
|
4.4%
14/315 • Number of events 14 • Adverse event data was collected for participants using the nicotine patch during 8 weeks of active patch treatment. Adverse event data was collected for participants using the nicotine patch and nicotine mini-lozenge during 26 weeks of active use of these 2 medications post-quit.
Adverse events (AEs) and serious AEs (SAEs) were assessed with the question "Since your last contact with us, have there been any changes in your medical condition or health?" * For each nicotine-medication-related symptom reported, severity was assessed and whether the symptom has resolved. * For any non-nicotine-medication-related symptoms that are reported as a concern, participants were advised to contact their primary care provider in the clinic as per IRB approval.
|
5.2%
16/308 • Number of events 16 • Adverse event data was collected for participants using the nicotine patch during 8 weeks of active patch treatment. Adverse event data was collected for participants using the nicotine patch and nicotine mini-lozenge during 26 weeks of active use of these 2 medications post-quit.
Adverse events (AEs) and serious AEs (SAEs) were assessed with the question "Since your last contact with us, have there been any changes in your medical condition or health?" * For each nicotine-medication-related symptom reported, severity was assessed and whether the symptom has resolved. * For any non-nicotine-medication-related symptoms that are reported as a concern, participants were advised to contact their primary care provider in the clinic as per IRB approval.
|
|
Gastrointestinal disorders
Hiccups
|
0.32%
1/315 • Number of events 1 • Adverse event data was collected for participants using the nicotine patch during 8 weeks of active patch treatment. Adverse event data was collected for participants using the nicotine patch and nicotine mini-lozenge during 26 weeks of active use of these 2 medications post-quit.
Adverse events (AEs) and serious AEs (SAEs) were assessed with the question "Since your last contact with us, have there been any changes in your medical condition or health?" * For each nicotine-medication-related symptom reported, severity was assessed and whether the symptom has resolved. * For any non-nicotine-medication-related symptoms that are reported as a concern, participants were advised to contact their primary care provider in the clinic as per IRB approval.
|
6.8%
21/308 • Number of events 21 • Adverse event data was collected for participants using the nicotine patch during 8 weeks of active patch treatment. Adverse event data was collected for participants using the nicotine patch and nicotine mini-lozenge during 26 weeks of active use of these 2 medications post-quit.
Adverse events (AEs) and serious AEs (SAEs) were assessed with the question "Since your last contact with us, have there been any changes in your medical condition or health?" * For each nicotine-medication-related symptom reported, severity was assessed and whether the symptom has resolved. * For any non-nicotine-medication-related symptoms that are reported as a concern, participants were advised to contact their primary care provider in the clinic as per IRB approval.
|
|
General disorders
Mouth Problem
|
0.00%
0/315 • Adverse event data was collected for participants using the nicotine patch during 8 weeks of active patch treatment. Adverse event data was collected for participants using the nicotine patch and nicotine mini-lozenge during 26 weeks of active use of these 2 medications post-quit.
Adverse events (AEs) and serious AEs (SAEs) were assessed with the question "Since your last contact with us, have there been any changes in your medical condition or health?" * For each nicotine-medication-related symptom reported, severity was assessed and whether the symptom has resolved. * For any non-nicotine-medication-related symptoms that are reported as a concern, participants were advised to contact their primary care provider in the clinic as per IRB approval.
|
4.9%
15/308 • Number of events 15 • Adverse event data was collected for participants using the nicotine patch during 8 weeks of active patch treatment. Adverse event data was collected for participants using the nicotine patch and nicotine mini-lozenge during 26 weeks of active use of these 2 medications post-quit.
Adverse events (AEs) and serious AEs (SAEs) were assessed with the question "Since your last contact with us, have there been any changes in your medical condition or health?" * For each nicotine-medication-related symptom reported, severity was assessed and whether the symptom has resolved. * For any non-nicotine-medication-related symptoms that are reported as a concern, participants were advised to contact their primary care provider in the clinic as per IRB approval.
|
|
Gastrointestinal disorders
Persistent Indigestion
|
2.2%
7/315 • Number of events 7 • Adverse event data was collected for participants using the nicotine patch during 8 weeks of active patch treatment. Adverse event data was collected for participants using the nicotine patch and nicotine mini-lozenge during 26 weeks of active use of these 2 medications post-quit.
Adverse events (AEs) and serious AEs (SAEs) were assessed with the question "Since your last contact with us, have there been any changes in your medical condition or health?" * For each nicotine-medication-related symptom reported, severity was assessed and whether the symptom has resolved. * For any non-nicotine-medication-related symptoms that are reported as a concern, participants were advised to contact their primary care provider in the clinic as per IRB approval.
|
11.0%
34/308 • Number of events 34 • Adverse event data was collected for participants using the nicotine patch during 8 weeks of active patch treatment. Adverse event data was collected for participants using the nicotine patch and nicotine mini-lozenge during 26 weeks of active use of these 2 medications post-quit.
Adverse events (AEs) and serious AEs (SAEs) were assessed with the question "Since your last contact with us, have there been any changes in your medical condition or health?" * For each nicotine-medication-related symptom reported, severity was assessed and whether the symptom has resolved. * For any non-nicotine-medication-related symptoms that are reported as a concern, participants were advised to contact their primary care provider in the clinic as per IRB approval.
|
Additional Information
Stevens S. Smith, Ph.D.
Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health
Phone: 6082627563
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place