Trial Outcomes & Findings for Enhanced E-cigarette Coaching Intervention for Dual Users of Cigarettes and E-cigarettes (NCT NCT03575468)
NCT ID: NCT03575468
Last Updated: 2023-10-16
Results Overview
In Phase 2, average treatment satisfaction and acceptability rating will be compared for EEC and TAU participants. Full 1-6 scale description: 1 - very satisfied; 2 - satisfied; 3 - somewhat satisfied; 4 - somewhat dissatisfied; 5 - dissatisfied; 6 - very dissatisfied. Participants can also respond "I don't know" or "I prefer not to answer". On scale 1-6, 1 is the best outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
110 participants
Primary outcome timeframe
3 months after baseline
Results posted on
2023-10-16
Participant Flow
Participant milestones
| Measure |
Enhanced E-cigarette Coaching (EEC)
The EEC intervention calls will include assessment of e-cigarette use and discussion about how and why e-cigarettes are being used on every call. In addition to the standard quitline cessation program, the enhanced program will include education (via quit coaches and two tailored quit guides), behavioral support tailored to dual users, and shared decision making strategies to address how and why FDA-approved quitting aids and ENDS are being used and to develop an integrated quit plan based on callers' decisions.
Enhanced E-cigarette Coaching: The EEC intervention calls will include assessment of e-cigarette use and discussion about how and why e-cigarettes are being used on every call. In addition to the standard quitline cessation program, the enhanced program will include education (via quit coaches and two tailored quit guides), behavioral support tailored to dual users, and shared decision making strategies to address how and why FDA-approved quitting aids and ENDS are being used and to develop an integrated quit plan based on callers' decisions.
|
Quitline Treatment as Usual (TAU)
The standard tobacco quitline program is a proactive 5-call intervention grounded in social cognitive theory and the U.S. Public Health Service clinical practices guidelines for treating tobacco use and dependence. All enrollees in the study are eligible for 2-8 weeks of nicotine replacement therapy (depending on their standard quitline benefit offering), if they medically qualify and/or return a medical override letter from their doctor.
Quitline treatment as usual: The standard tobacco quitline program is a proactive 5-call intervention grounded in social cognitive theory and the U.S. Public Health Service clinical practices guidelines for treating tobacco use and dependence. All enrollees in the study are eligible for 2-8 weeks of nicotine replacement therapy (depending on their standard quitline benefit offering), if they medically qualify and/or return a medical override letter from their doctor.
|
|---|---|---|
|
Overall Study
STARTED
|
56
|
54
|
|
Overall Study
COMPLETED
|
30
|
33
|
|
Overall Study
NOT COMPLETED
|
26
|
21
|
Reasons for withdrawal
| Measure |
Enhanced E-cigarette Coaching (EEC)
The EEC intervention calls will include assessment of e-cigarette use and discussion about how and why e-cigarettes are being used on every call. In addition to the standard quitline cessation program, the enhanced program will include education (via quit coaches and two tailored quit guides), behavioral support tailored to dual users, and shared decision making strategies to address how and why FDA-approved quitting aids and ENDS are being used and to develop an integrated quit plan based on callers' decisions.
Enhanced E-cigarette Coaching: The EEC intervention calls will include assessment of e-cigarette use and discussion about how and why e-cigarettes are being used on every call. In addition to the standard quitline cessation program, the enhanced program will include education (via quit coaches and two tailored quit guides), behavioral support tailored to dual users, and shared decision making strategies to address how and why FDA-approved quitting aids and ENDS are being used and to develop an integrated quit plan based on callers' decisions.
|
Quitline Treatment as Usual (TAU)
The standard tobacco quitline program is a proactive 5-call intervention grounded in social cognitive theory and the U.S. Public Health Service clinical practices guidelines for treating tobacco use and dependence. All enrollees in the study are eligible for 2-8 weeks of nicotine replacement therapy (depending on their standard quitline benefit offering), if they medically qualify and/or return a medical override letter from their doctor.
Quitline treatment as usual: The standard tobacco quitline program is a proactive 5-call intervention grounded in social cognitive theory and the U.S. Public Health Service clinical practices guidelines for treating tobacco use and dependence. All enrollees in the study are eligible for 2-8 weeks of nicotine replacement therapy (depending on their standard quitline benefit offering), if they medically qualify and/or return a medical override letter from their doctor.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
|
Overall Study
Call 1 completion required to stay in study per consent process (not contacted for 3-month survey)
|
10
|
4
|
|
Overall Study
Lost to Follow-up
|
13
|
17
|
Baseline Characteristics
Enhanced E-cigarette Coaching Intervention for Dual Users of Cigarettes and E-cigarettes
Baseline characteristics by cohort
| Measure |
Enhanced E-cigarette Coaching (EEC)
n=46 Participants
The EEC intervention calls will include assessment of e-cigarette use and discussion about how and why e-cigarettes are being used on every call. In addition to the standard quitline cessation program, the enhanced program will include education (via quit coaches and two tailored quit guides), behavioral support tailored to dual users, and shared decision making strategies to address how and why FDA-approved quitting aids and ENDS are being used and to develop an integrated quit plan based on callers' decisions.
Enhanced E-cigarette Coaching: The EEC intervention calls will include assessment of e-cigarette use and discussion about how and why e-cigarettes are being used on every call. In addition to the standard quitline cessation program, the enhanced program will include education (via quit coaches and two tailored quit guides), behavioral support tailored to dual users, and shared decision making strategies to address how and why FDA-approved quitting aids and ENDS are being used and to develop an integrated quit plan based on callers' decisions.
|
Quitline Treatment as Usual (TAU)
n=50 Participants
The standard tobacco quitline program is a proactive 5-call intervention grounded in social cognitive theory and the U.S. Public Health Service clinical practices guidelines for treating tobacco use and dependence. All enrollees in the study are eligible for 2-8 weeks of nicotine replacement therapy (depending on their standard quitline benefit offering), if they medically qualify and/or return a medical override letter from their doctor.
Quitline treatment as usual: The standard tobacco quitline program is a proactive 5-call intervention grounded in social cognitive theory and the U.S. Public Health Service clinical practices guidelines for treating tobacco use and dependence. All enrollees in the study are eligible for 2-8 weeks of nicotine replacement therapy (depending on their standard quitline benefit offering), if they medically qualify and/or return a medical override letter from their doctor.
|
Total
n=96 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
|
|
Age, Categorical
Between 18 and 65 years
|
43 Participants
n=93 Participants
|
47 Participants
n=4 Participants
|
90 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=93 Participants
|
29 Participants
n=4 Participants
|
59 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
37 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
5 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 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
|
5 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
62 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
46 participants
n=93 Participants
|
50 participants
n=4 Participants
|
96 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 3 months after baselinePopulation: This analysis focused on 3-month survey respondents (N=66).
In Phase 2, average treatment satisfaction and acceptability rating will be compared for EEC and TAU participants. Full 1-6 scale description: 1 - very satisfied; 2 - satisfied; 3 - somewhat satisfied; 4 - somewhat dissatisfied; 5 - dissatisfied; 6 - very dissatisfied. Participants can also respond "I don't know" or "I prefer not to answer". On scale 1-6, 1 is the best outcome.
Outcome measures
| Measure |
Enhanced E-cigarette Coaching (EEC)
n=32 Participants
The EEC intervention calls will include assessment of e-cigarette use and discussion about how and why e-cigarettes are being used on every call. In addition to the standard quitline cessation program, the enhanced program will include education (via quit coaches and two tailored quit guides), behavioral support tailored to dual users, and shared decision making strategies to address how and why FDA-approved quitting aids and ENDS are being used and to develop an integrated quit plan based on callers' decisions.
Enhanced E-cigarette Coaching: The EEC intervention calls will include assessment of e-cigarette use and discussion about how and why e-cigarettes are being used on every call. In addition to the standard quitline cessation program, the enhanced program will include education (via quit coaches and two tailored quit guides), behavioral support tailored to dual users, and shared decision making strategies to address how and why FDA-approved quitting aids and ENDS are being used and to develop an integrated quit plan based on callers' decisions.
|
Quitline Treatment as Usual (TAU)
n=34 Participants
The standard tobacco quitline program is a proactive 5-call intervention grounded in social cognitive theory and the U.S. Public Health Service clinical practices guidelines for treating tobacco use and dependence. All enrollees in the study are eligible for 2-8 weeks of nicotine replacement therapy (depending on their standard quitline benefit offering), if they medically qualify and/or return a medical override letter from their doctor.
Quitline treatment as usual: The standard tobacco quitline program is a proactive 5-call intervention grounded in social cognitive theory and the U.S. Public Health Service clinical practices guidelines for treating tobacco use and dependence. All enrollees in the study are eligible for 2-8 weeks of nicotine replacement therapy (depending on their standard quitline benefit offering), if they medically qualify and/or return a medical override letter from their doctor.
|
|---|---|---|
|
Treatment Satisfaction and Acceptability Measured on a Scale From 1-6 (Very Satisfied to Very Dissatisfied)
|
5.5 units on a scale
Interval 5.3 to 5.8
|
5.0 units on a scale
Interval 4.5 to 5.5
|
PRIMARY outcome
Timeframe: Phase 2 time frame: 3 months after baselineIn Phase 2, call completion (captured via standard quitline data systems) will be compared for EEC and TAU participants. There is no limit to number of calls that can be completed, although participants are called to complete 5 scheduled calls (best outcome).
Outcome measures
| Measure |
Enhanced E-cigarette Coaching (EEC)
n=32 Participants
The EEC intervention calls will include assessment of e-cigarette use and discussion about how and why e-cigarettes are being used on every call. In addition to the standard quitline cessation program, the enhanced program will include education (via quit coaches and two tailored quit guides), behavioral support tailored to dual users, and shared decision making strategies to address how and why FDA-approved quitting aids and ENDS are being used and to develop an integrated quit plan based on callers' decisions.
Enhanced E-cigarette Coaching: The EEC intervention calls will include assessment of e-cigarette use and discussion about how and why e-cigarettes are being used on every call. In addition to the standard quitline cessation program, the enhanced program will include education (via quit coaches and two tailored quit guides), behavioral support tailored to dual users, and shared decision making strategies to address how and why FDA-approved quitting aids and ENDS are being used and to develop an integrated quit plan based on callers' decisions.
|
Quitline Treatment as Usual (TAU)
n=34 Participants
The standard tobacco quitline program is a proactive 5-call intervention grounded in social cognitive theory and the U.S. Public Health Service clinical practices guidelines for treating tobacco use and dependence. All enrollees in the study are eligible for 2-8 weeks of nicotine replacement therapy (depending on their standard quitline benefit offering), if they medically qualify and/or return a medical override letter from their doctor.
Quitline treatment as usual: The standard tobacco quitline program is a proactive 5-call intervention grounded in social cognitive theory and the U.S. Public Health Service clinical practices guidelines for treating tobacco use and dependence. All enrollees in the study are eligible for 2-8 weeks of nicotine replacement therapy (depending on their standard quitline benefit offering), if they medically qualify and/or return a medical override letter from their doctor.
|
|---|---|---|
|
Treatment Engagement: Call Completion
|
3.4 Coaching calls completed
Standard Deviation .24
|
2.7 Coaching calls completed
Standard Deviation .19
|
SECONDARY outcome
Timeframe: 3 months after baselinePopulation: Analysis focused on 3-month survey respondents (N=66).
In Phase 2, quit plan development experience will be compared for EEC and TAU participants. Quit plan development experience will be measured with an adapted version of the CollaboRATE (not an abbreviation) shared decision making assessment measure. The adapted CollaboRATE measure included 3 questions (on a 5-point scale from "no effort (0)" to "every effort was made (4)"): "How much effort was made to help you understand your options for quitting smoking?", "How much effort was made to listen to the things that matter most to you about your plan for quitting smoking?", and "How much effort was made to include what matters most to you in creating your plan for quitting smoking?". Higher total scores indicate greater utilization of a shared decision-making approach during quit plan development. Scale minimum equals 0 and maximum equals 12.
Outcome measures
| Measure |
Enhanced E-cigarette Coaching (EEC)
n=32 Participants
The EEC intervention calls will include assessment of e-cigarette use and discussion about how and why e-cigarettes are being used on every call. In addition to the standard quitline cessation program, the enhanced program will include education (via quit coaches and two tailored quit guides), behavioral support tailored to dual users, and shared decision making strategies to address how and why FDA-approved quitting aids and ENDS are being used and to develop an integrated quit plan based on callers' decisions.
Enhanced E-cigarette Coaching: The EEC intervention calls will include assessment of e-cigarette use and discussion about how and why e-cigarettes are being used on every call. In addition to the standard quitline cessation program, the enhanced program will include education (via quit coaches and two tailored quit guides), behavioral support tailored to dual users, and shared decision making strategies to address how and why FDA-approved quitting aids and ENDS are being used and to develop an integrated quit plan based on callers' decisions.
|
Quitline Treatment as Usual (TAU)
n=34 Participants
The standard tobacco quitline program is a proactive 5-call intervention grounded in social cognitive theory and the U.S. Public Health Service clinical practices guidelines for treating tobacco use and dependence. All enrollees in the study are eligible for 2-8 weeks of nicotine replacement therapy (depending on their standard quitline benefit offering), if they medically qualify and/or return a medical override letter from their doctor.
Quitline treatment as usual: The standard tobacco quitline program is a proactive 5-call intervention grounded in social cognitive theory and the U.S. Public Health Service clinical practices guidelines for treating tobacco use and dependence. All enrollees in the study are eligible for 2-8 weeks of nicotine replacement therapy (depending on their standard quitline benefit offering), if they medically qualify and/or return a medical override letter from their doctor.
|
|---|---|---|
|
Quit Plan Development Experience
|
10.0 score on a scale
Standard Error 0.4
|
9.2 score on a scale
Standard Error 0.6
|
SECONDARY outcome
Timeframe: Phase 2 time frame: 3 months after baselinePopulation: Respondents to the 3-month survey
In Phase 2, Knowledge and Beliefs about ENDS, Smoking, and FDA-approved Cessation Medications was assessed via 3 relative risk questions about ENDS, Smoking, and FDA-approved Cessation Medications designed for this study, and compared for EEC and TAU participants. Responses to individual items will be described. To assess the relative risk of ENDS and cigarettes, the following question was asked, "Compared to cigarettes, how harmful are e-cigarettes to a person's health?" Answer responses included: less harmful, about the same, more harmful, and I prefer not to answer.
Outcome measures
| Measure |
Enhanced E-cigarette Coaching (EEC)
n=30 Participants
The EEC intervention calls will include assessment of e-cigarette use and discussion about how and why e-cigarettes are being used on every call. In addition to the standard quitline cessation program, the enhanced program will include education (via quit coaches and two tailored quit guides), behavioral support tailored to dual users, and shared decision making strategies to address how and why FDA-approved quitting aids and ENDS are being used and to develop an integrated quit plan based on callers' decisions.
Enhanced E-cigarette Coaching: The EEC intervention calls will include assessment of e-cigarette use and discussion about how and why e-cigarettes are being used on every call. In addition to the standard quitline cessation program, the enhanced program will include education (via quit coaches and two tailored quit guides), behavioral support tailored to dual users, and shared decision making strategies to address how and why FDA-approved quitting aids and ENDS are being used and to develop an integrated quit plan based on callers' decisions.
|
Quitline Treatment as Usual (TAU)
n=33 Participants
The standard tobacco quitline program is a proactive 5-call intervention grounded in social cognitive theory and the U.S. Public Health Service clinical practices guidelines for treating tobacco use and dependence. All enrollees in the study are eligible for 2-8 weeks of nicotine replacement therapy (depending on their standard quitline benefit offering), if they medically qualify and/or return a medical override letter from their doctor.
Quitline treatment as usual: The standard tobacco quitline program is a proactive 5-call intervention grounded in social cognitive theory and the U.S. Public Health Service clinical practices guidelines for treating tobacco use and dependence. All enrollees in the study are eligible for 2-8 weeks of nicotine replacement therapy (depending on their standard quitline benefit offering), if they medically qualify and/or return a medical override letter from their doctor.
|
|---|---|---|
|
Knowledge and Beliefs- Relative Risk of ENDS and Cigarettes
Less Harmful
|
22 Participants
|
22 Participants
|
|
Knowledge and Beliefs- Relative Risk of ENDS and Cigarettes
About the Same
|
6 Participants
|
5 Participants
|
|
Knowledge and Beliefs- Relative Risk of ENDS and Cigarettes
More Harmful
|
0 Participants
|
5 Participants
|
|
Knowledge and Beliefs- Relative Risk of ENDS and Cigarettes
I prefer not to answer
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Phase 2 time frame: 3 months after baselinePopulation: Respondents to the 3-month survey
In Phase 2, Knowledge and Beliefs about ENDS, Smoking, and FDA-approved Cessation Medications was assessed via 3 relative risk questions about ENDS, Smoking, and FDA-approved Cessation Medications designed for this study, and compared for EEC and TAU participants. Responses to individual items will be described. To assess the relative risk of FDA-approved Cessation Medications and cigarettes, the following question was asked, "Compared to cigarettes, how harmful are quit medications like the nicotine patch to a person's health?" Answer responses included: less harmful, about the same, more harmful, and I prefer not to answer.
Outcome measures
| Measure |
Enhanced E-cigarette Coaching (EEC)
n=30 Participants
The EEC intervention calls will include assessment of e-cigarette use and discussion about how and why e-cigarettes are being used on every call. In addition to the standard quitline cessation program, the enhanced program will include education (via quit coaches and two tailored quit guides), behavioral support tailored to dual users, and shared decision making strategies to address how and why FDA-approved quitting aids and ENDS are being used and to develop an integrated quit plan based on callers' decisions.
Enhanced E-cigarette Coaching: The EEC intervention calls will include assessment of e-cigarette use and discussion about how and why e-cigarettes are being used on every call. In addition to the standard quitline cessation program, the enhanced program will include education (via quit coaches and two tailored quit guides), behavioral support tailored to dual users, and shared decision making strategies to address how and why FDA-approved quitting aids and ENDS are being used and to develop an integrated quit plan based on callers' decisions.
|
Quitline Treatment as Usual (TAU)
n=33 Participants
The standard tobacco quitline program is a proactive 5-call intervention grounded in social cognitive theory and the U.S. Public Health Service clinical practices guidelines for treating tobacco use and dependence. All enrollees in the study are eligible for 2-8 weeks of nicotine replacement therapy (depending on their standard quitline benefit offering), if they medically qualify and/or return a medical override letter from their doctor.
Quitline treatment as usual: The standard tobacco quitline program is a proactive 5-call intervention grounded in social cognitive theory and the U.S. Public Health Service clinical practices guidelines for treating tobacco use and dependence. All enrollees in the study are eligible for 2-8 weeks of nicotine replacement therapy (depending on their standard quitline benefit offering), if they medically qualify and/or return a medical override letter from their doctor.
|
|---|---|---|
|
Knowledge and Beliefs- Relative Risk of FDA-approved Cessation Medications and Cigarettes
Less Harmful
|
25 Participants
|
32 Participants
|
|
Knowledge and Beliefs- Relative Risk of FDA-approved Cessation Medications and Cigarettes
About the Same
|
1 Participants
|
1 Participants
|
|
Knowledge and Beliefs- Relative Risk of FDA-approved Cessation Medications and Cigarettes
More Harmful
|
1 Participants
|
0 Participants
|
|
Knowledge and Beliefs- Relative Risk of FDA-approved Cessation Medications and Cigarettes
I Prefer Not to Answer
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Phase 2 time frame: 3 months after baselinePopulation: Respondents to the 3-month survey
In Phase 2, Knowledge and Beliefs about ENDS, Smoking, and FDA-approved Cessation Medications was assessed via 3 relative risk questions about ENDS, Smoking, and FDA-approved Cessation Medications designed for this study, and compared for EEC and TAU participants. Responses to individual items will be described. To assess the relative risk of FDA-approved Cessation Medications and ENDS, the following question was asked, "Compared to quit medications like the nicotine patch, how harmful are e-cigarettes to a person's health?" Answer responses included: less harmful, about the same, more harmful, and I prefer not to answer.
Outcome measures
| Measure |
Enhanced E-cigarette Coaching (EEC)
n=30 Participants
The EEC intervention calls will include assessment of e-cigarette use and discussion about how and why e-cigarettes are being used on every call. In addition to the standard quitline cessation program, the enhanced program will include education (via quit coaches and two tailored quit guides), behavioral support tailored to dual users, and shared decision making strategies to address how and why FDA-approved quitting aids and ENDS are being used and to develop an integrated quit plan based on callers' decisions.
Enhanced E-cigarette Coaching: The EEC intervention calls will include assessment of e-cigarette use and discussion about how and why e-cigarettes are being used on every call. In addition to the standard quitline cessation program, the enhanced program will include education (via quit coaches and two tailored quit guides), behavioral support tailored to dual users, and shared decision making strategies to address how and why FDA-approved quitting aids and ENDS are being used and to develop an integrated quit plan based on callers' decisions.
|
Quitline Treatment as Usual (TAU)
n=33 Participants
The standard tobacco quitline program is a proactive 5-call intervention grounded in social cognitive theory and the U.S. Public Health Service clinical practices guidelines for treating tobacco use and dependence. All enrollees in the study are eligible for 2-8 weeks of nicotine replacement therapy (depending on their standard quitline benefit offering), if they medically qualify and/or return a medical override letter from their doctor.
Quitline treatment as usual: The standard tobacco quitline program is a proactive 5-call intervention grounded in social cognitive theory and the U.S. Public Health Service clinical practices guidelines for treating tobacco use and dependence. All enrollees in the study are eligible for 2-8 weeks of nicotine replacement therapy (depending on their standard quitline benefit offering), if they medically qualify and/or return a medical override letter from their doctor.
|
|---|---|---|
|
Knowledge and Beliefs- Relative Risk of FDA-approved Cessation Medications and ENDS
Less Harmful
|
12 Participants
|
4 Participants
|
|
Knowledge and Beliefs- Relative Risk of FDA-approved Cessation Medications and ENDS
About the Same
|
5 Participants
|
9 Participants
|
|
Knowledge and Beliefs- Relative Risk of FDA-approved Cessation Medications and ENDS
More Harmful
|
10 Participants
|
19 Participants
|
|
Knowledge and Beliefs- Relative Risk of FDA-approved Cessation Medications and ENDS
I Prefer Not to Answer
|
3 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Phase 2 time frame: 3 months after baselineIn Phase 2 participants will report their quit status during their outcome survey.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 12 weeksA descriptive analysis of how ENDS, NRT, and cigarettes are used during a participant's quit process through diary procedures.
Outcome measures
Outcome data not reported
Adverse Events
Enhanced E-cigarette Coaching (EEC)
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Quitline Treatment as Usual (TAU)
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Enhanced E-cigarette Coaching (EEC)
n=30 participants at risk；n=46 participants at risk
The EEC intervention calls will include assessment of e-cigarette use and discussion about how and why e-cigarettes are being used on every call. In addition to the standard quitline cessation program, the enhanced program will include education (via quit coaches and two tailored quit guides), behavioral support tailored to dual users, and shared decision making strategies to address how and why FDA-approved quitting aids and ENDS are being used and to develop an integrated quit plan based on callers' decisions.
Enhanced E-cigarette Coaching: The EEC intervention calls will include assessment of e-cigarette use and discussion about how and why e-cigarettes are being used on every call. In addition to the standard quitline cessation program, the enhanced program will include education (via quit coaches and two tailored quit guides), behavioral support tailored to dual users, and shared decision making strategies to address how and why FDA-approved quitting aids and ENDS are being used and to develop an integrated quit plan based on callers' decisions.
|
Quitline Treatment as Usual (TAU)
n=33 participants at risk；n=50 participants at risk
The standard tobacco quitline program is a proactive 5-call intervention grounded in social cognitive theory and the U.S. Public Health Service clinical practices guidelines for treating tobacco use and dependence. All enrollees in the study are eligible for 2-8 weeks of nicotine replacement therapy (depending on their standard quitline benefit offering), if they medically qualify and/or return a medical override letter from their doctor.
Quitline treatment as usual: The standard tobacco quitline program is a proactive 5-call intervention grounded in social cognitive theory and the U.S. Public Health Service clinical practices guidelines for treating tobacco use and dependence. All enrollees in the study are eligible for 2-8 weeks of nicotine replacement therapy (depending on their standard quitline benefit offering), if they medically qualify and/or return a medical override letter from their doctor.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Sore throat d/t reported use of e-cigarette
|
34.6%
9/26 • Outcomes surveys were completed approximately 3-months after baseline and randomization.
Only participants who responded to the 3-month survey and reported use of e-cigs and/or NRT were assessed for Other (Not Including Serious) Adverse Events. Participants who reported use of e-cigs or NRT since study enrollment were asked whether they experienced any side effects related to (1) using e-cigs (if they reported use) and (2) related to using NRT (if they reported use) using two separate questions. Participants could be at risk for adverse events related to both NRT and e-cig use.
|
15.4%
4/26 • Outcomes surveys were completed approximately 3-months after baseline and randomization.
Only participants who responded to the 3-month survey and reported use of e-cigs and/or NRT were assessed for Other (Not Including Serious) Adverse Events. Participants who reported use of e-cigs or NRT since study enrollment were asked whether they experienced any side effects related to (1) using e-cigs (if they reported use) and (2) related to using NRT (if they reported use) using two separate questions. Participants could be at risk for adverse events related to both NRT and e-cig use.
|
|
General disorders
Headache d/t reported use of e-cigarettes
|
23.1%
6/26 • Outcomes surveys were completed approximately 3-months after baseline and randomization.
Only participants who responded to the 3-month survey and reported use of e-cigs and/or NRT were assessed for Other (Not Including Serious) Adverse Events. Participants who reported use of e-cigs or NRT since study enrollment were asked whether they experienced any side effects related to (1) using e-cigs (if they reported use) and (2) related to using NRT (if they reported use) using two separate questions. Participants could be at risk for adverse events related to both NRT and e-cig use.
|
3.8%
1/26 • Outcomes surveys were completed approximately 3-months after baseline and randomization.
Only participants who responded to the 3-month survey and reported use of e-cigs and/or NRT were assessed for Other (Not Including Serious) Adverse Events. Participants who reported use of e-cigs or NRT since study enrollment were asked whether they experienced any side effects related to (1) using e-cigs (if they reported use) and (2) related to using NRT (if they reported use) using two separate questions. Participants could be at risk for adverse events related to both NRT and e-cig use.
|
|
General disorders
Breathing difficulties d/t reported e-cigarette use
|
11.5%
3/26 • Outcomes surveys were completed approximately 3-months after baseline and randomization.
Only participants who responded to the 3-month survey and reported use of e-cigs and/or NRT were assessed for Other (Not Including Serious) Adverse Events. Participants who reported use of e-cigs or NRT since study enrollment were asked whether they experienced any side effects related to (1) using e-cigs (if they reported use) and (2) related to using NRT (if they reported use) using two separate questions. Participants could be at risk for adverse events related to both NRT and e-cig use.
|
15.4%
4/26 • Outcomes surveys were completed approximately 3-months after baseline and randomization.
Only participants who responded to the 3-month survey and reported use of e-cigs and/or NRT were assessed for Other (Not Including Serious) Adverse Events. Participants who reported use of e-cigs or NRT since study enrollment were asked whether they experienced any side effects related to (1) using e-cigs (if they reported use) and (2) related to using NRT (if they reported use) using two separate questions. Participants could be at risk for adverse events related to both NRT and e-cig use.
|
|
Respiratory, thoracic and mediastinal disorders
Cough d/t reported e-cigarette use
|
11.5%
3/26 • Outcomes surveys were completed approximately 3-months after baseline and randomization.
Only participants who responded to the 3-month survey and reported use of e-cigs and/or NRT were assessed for Other (Not Including Serious) Adverse Events. Participants who reported use of e-cigs or NRT since study enrollment were asked whether they experienced any side effects related to (1) using e-cigs (if they reported use) and (2) related to using NRT (if they reported use) using two separate questions. Participants could be at risk for adverse events related to both NRT and e-cig use.
|
7.7%
2/26 • Outcomes surveys were completed approximately 3-months after baseline and randomization.
Only participants who responded to the 3-month survey and reported use of e-cigs and/or NRT were assessed for Other (Not Including Serious) Adverse Events. Participants who reported use of e-cigs or NRT since study enrollment were asked whether they experienced any side effects related to (1) using e-cigs (if they reported use) and (2) related to using NRT (if they reported use) using two separate questions. Participants could be at risk for adverse events related to both NRT and e-cig use.
|
|
General disorders
Dizziness d/t reported e-cigarette use
|
11.5%
3/26 • Outcomes surveys were completed approximately 3-months after baseline and randomization.
Only participants who responded to the 3-month survey and reported use of e-cigs and/or NRT were assessed for Other (Not Including Serious) Adverse Events. Participants who reported use of e-cigs or NRT since study enrollment were asked whether they experienced any side effects related to (1) using e-cigs (if they reported use) and (2) related to using NRT (if they reported use) using two separate questions. Participants could be at risk for adverse events related to both NRT and e-cig use.
|
7.7%
2/26 • Outcomes surveys were completed approximately 3-months after baseline and randomization.
Only participants who responded to the 3-month survey and reported use of e-cigs and/or NRT were assessed for Other (Not Including Serious) Adverse Events. Participants who reported use of e-cigs or NRT since study enrollment were asked whether they experienced any side effects related to (1) using e-cigs (if they reported use) and (2) related to using NRT (if they reported use) using two separate questions. Participants could be at risk for adverse events related to both NRT and e-cig use.
|
|
General disorders
Bad or vivid dreams/nightmares d/t reported e-cigarette use
|
11.5%
3/26 • Outcomes surveys were completed approximately 3-months after baseline and randomization.
Only participants who responded to the 3-month survey and reported use of e-cigs and/or NRT were assessed for Other (Not Including Serious) Adverse Events. Participants who reported use of e-cigs or NRT since study enrollment were asked whether they experienced any side effects related to (1) using e-cigs (if they reported use) and (2) related to using NRT (if they reported use) using two separate questions. Participants could be at risk for adverse events related to both NRT and e-cig use.
|
3.8%
1/26 • Outcomes surveys were completed approximately 3-months after baseline and randomization.
Only participants who responded to the 3-month survey and reported use of e-cigs and/or NRT were assessed for Other (Not Including Serious) Adverse Events. Participants who reported use of e-cigs or NRT since study enrollment were asked whether they experienced any side effects related to (1) using e-cigs (if they reported use) and (2) related to using NRT (if they reported use) using two separate questions. Participants could be at risk for adverse events related to both NRT and e-cig use.
|
|
General disorders
Nausea/stomach upset d/t reported e-cigarette use
|
7.7%
2/26 • Outcomes surveys were completed approximately 3-months after baseline and randomization.
Only participants who responded to the 3-month survey and reported use of e-cigs and/or NRT were assessed for Other (Not Including Serious) Adverse Events. Participants who reported use of e-cigs or NRT since study enrollment were asked whether they experienced any side effects related to (1) using e-cigs (if they reported use) and (2) related to using NRT (if they reported use) using two separate questions. Participants could be at risk for adverse events related to both NRT and e-cig use.
|
3.8%
1/26 • Outcomes surveys were completed approximately 3-months after baseline and randomization.
Only participants who responded to the 3-month survey and reported use of e-cigs and/or NRT were assessed for Other (Not Including Serious) Adverse Events. Participants who reported use of e-cigs or NRT since study enrollment were asked whether they experienced any side effects related to (1) using e-cigs (if they reported use) and (2) related to using NRT (if they reported use) using two separate questions. Participants could be at risk for adverse events related to both NRT and e-cig use.
|
|
General disorders
Chest pain d/t reported e-cigarette use
|
3.8%
1/26 • Outcomes surveys were completed approximately 3-months after baseline and randomization.
Only participants who responded to the 3-month survey and reported use of e-cigs and/or NRT were assessed for Other (Not Including Serious) Adverse Events. Participants who reported use of e-cigs or NRT since study enrollment were asked whether they experienced any side effects related to (1) using e-cigs (if they reported use) and (2) related to using NRT (if they reported use) using two separate questions. Participants could be at risk for adverse events related to both NRT and e-cig use.
|
7.7%
2/26 • Outcomes surveys were completed approximately 3-months after baseline and randomization.
Only participants who responded to the 3-month survey and reported use of e-cigs and/or NRT were assessed for Other (Not Including Serious) Adverse Events. Participants who reported use of e-cigs or NRT since study enrollment were asked whether they experienced any side effects related to (1) using e-cigs (if they reported use) and (2) related to using NRT (if they reported use) using two separate questions. Participants could be at risk for adverse events related to both NRT and e-cig use.
|
|
General disorders
Skin Irritation - rash, itchiness d/t reported NRT use
|
8.0%
2/25 • Outcomes surveys were completed approximately 3-months after baseline and randomization.
Only participants who responded to the 3-month survey and reported use of e-cigs and/or NRT were assessed for Other (Not Including Serious) Adverse Events. Participants who reported use of e-cigs or NRT since study enrollment were asked whether they experienced any side effects related to (1) using e-cigs (if they reported use) and (2) related to using NRT (if they reported use) using two separate questions. Participants could be at risk for adverse events related to both NRT and e-cig use.
|
6.7%
2/30 • Outcomes surveys were completed approximately 3-months after baseline and randomization.
Only participants who responded to the 3-month survey and reported use of e-cigs and/or NRT were assessed for Other (Not Including Serious) Adverse Events. Participants who reported use of e-cigs or NRT since study enrollment were asked whether they experienced any side effects related to (1) using e-cigs (if they reported use) and (2) related to using NRT (if they reported use) using two separate questions. Participants could be at risk for adverse events related to both NRT and e-cig use.
|
|
General disorders
Headache d/t reported NRT use
|
12.0%
3/25 • Outcomes surveys were completed approximately 3-months after baseline and randomization.
Only participants who responded to the 3-month survey and reported use of e-cigs and/or NRT were assessed for Other (Not Including Serious) Adverse Events. Participants who reported use of e-cigs or NRT since study enrollment were asked whether they experienced any side effects related to (1) using e-cigs (if they reported use) and (2) related to using NRT (if they reported use) using two separate questions. Participants could be at risk for adverse events related to both NRT and e-cig use.
|
6.7%
2/30 • Outcomes surveys were completed approximately 3-months after baseline and randomization.
Only participants who responded to the 3-month survey and reported use of e-cigs and/or NRT were assessed for Other (Not Including Serious) Adverse Events. Participants who reported use of e-cigs or NRT since study enrollment were asked whether they experienced any side effects related to (1) using e-cigs (if they reported use) and (2) related to using NRT (if they reported use) using two separate questions. Participants could be at risk for adverse events related to both NRT and e-cig use.
|
|
General disorders
Nausea/stomach upset d/t reported NRT use
|
4.0%
1/25 • Outcomes surveys were completed approximately 3-months after baseline and randomization.
Only participants who responded to the 3-month survey and reported use of e-cigs and/or NRT were assessed for Other (Not Including Serious) Adverse Events. Participants who reported use of e-cigs or NRT since study enrollment were asked whether they experienced any side effects related to (1) using e-cigs (if they reported use) and (2) related to using NRT (if they reported use) using two separate questions. Participants could be at risk for adverse events related to both NRT and e-cig use.
|
20.0%
6/30 • Outcomes surveys were completed approximately 3-months after baseline and randomization.
Only participants who responded to the 3-month survey and reported use of e-cigs and/or NRT were assessed for Other (Not Including Serious) Adverse Events. Participants who reported use of e-cigs or NRT since study enrollment were asked whether they experienced any side effects related to (1) using e-cigs (if they reported use) and (2) related to using NRT (if they reported use) using two separate questions. Participants could be at risk for adverse events related to both NRT and e-cig use.
|
|
General disorders
Any side effect d/t reported e-cigarette use
|
53.8%
14/26 • Outcomes surveys were completed approximately 3-months after baseline and randomization.
Only participants who responded to the 3-month survey and reported use of e-cigs and/or NRT were assessed for Other (Not Including Serious) Adverse Events. Participants who reported use of e-cigs or NRT since study enrollment were asked whether they experienced any side effects related to (1) using e-cigs (if they reported use) and (2) related to using NRT (if they reported use) using two separate questions. Participants could be at risk for adverse events related to both NRT and e-cig use.
|
42.3%
11/26 • Outcomes surveys were completed approximately 3-months after baseline and randomization.
Only participants who responded to the 3-month survey and reported use of e-cigs and/or NRT were assessed for Other (Not Including Serious) Adverse Events. Participants who reported use of e-cigs or NRT since study enrollment were asked whether they experienced any side effects related to (1) using e-cigs (if they reported use) and (2) related to using NRT (if they reported use) using two separate questions. Participants could be at risk for adverse events related to both NRT and e-cig use.
|
|
General disorders
Any side effect d/t NRT use
|
40.0%
10/25 • Outcomes surveys were completed approximately 3-months after baseline and randomization.
Only participants who responded to the 3-month survey and reported use of e-cigs and/or NRT were assessed for Other (Not Including Serious) Adverse Events. Participants who reported use of e-cigs or NRT since study enrollment were asked whether they experienced any side effects related to (1) using e-cigs (if they reported use) and (2) related to using NRT (if they reported use) using two separate questions. Participants could be at risk for adverse events related to both NRT and e-cig use.
|
40.0%
12/30 • Outcomes surveys were completed approximately 3-months after baseline and randomization.
Only participants who responded to the 3-month survey and reported use of e-cigs and/or NRT were assessed for Other (Not Including Serious) Adverse Events. Participants who reported use of e-cigs or NRT since study enrollment were asked whether they experienced any side effects related to (1) using e-cigs (if they reported use) and (2) related to using NRT (if they reported use) using two separate questions. Participants could be at risk for adverse events related to both NRT and e-cig use.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place