Trial Outcomes & Findings for Smoking Cessation Self-Help for Dual Users of Tobacco Cigarettes and E-Cigarettes (NCT NCT02416011)
NCT ID: NCT02416011
Last Updated: 2022-02-23
Results Overview
Percentage rate of smoking abstinence for participants who received If You Vape booklets, compared to: A) participants in an assessment-only condition; B) participants in a generic self-help condition comprising existing smoking cessation booklets.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
2896 participants
Primary outcome timeframe
18 months & 24 months post study enrollment
Results posted on
2022-02-23
Participant Flow
Participant milestones
| Measure |
Assessment Only (ASSESS)
Participants in this condition will not receive any intervention materials. They will participate solely in the repeated assessments. Including this comparison condition controls for the effect of repeated assessments and allows for the most meaningful evaluation of the efficacy effect size as well as the cost-effectiveness of the eTARGET intervention. This condition will also be the primary source of data for the secondary surveillance aim regarding naturalistic changes in smoking and e-cigarette use over time.
|
Generic Self-Help (GENERIC)
This will allow us to evaluate our novel self-help intervention for e-cigarette users (our If you Vape booklets) against a matched non-targeted intervention that has demonstrated efficacy for cigarette smokers in general. Such a comparison controls for the possibility that e-cigarette users are sufficiently primed to quit smoking and that even a generic, non-targeted intervention would be effective. This possibility will be directly tested by comparing this condition against both the ASSESS and eTARGET conditions in terms of clinical outcomes and cost-effectiveness.
GENERIC: The initial Stop Smoking for Good brochure, 10 Stop Smoking for Good booklets and 9 supportive My Story pamphlets delivered over 18 months, as used in our previous cessation study.
|
Targeted Self-Help (eTARGET)
Participants in this condition will receive the intervention created as the product of Study I.
eTARGET: The product of Study I is expected to include the initial If You Vape brochure, a series of 10 If You Vape: Guide to Quitting Smoking booklets, distributed over 18 months, and 9 supportive My Story pamphlets, delivered in the months between booklets.
|
|---|---|---|---|
|
Overall Study
STARTED
|
575
|
1154
|
1167
|
|
Overall Study
COMPLETED
|
561
|
1101
|
1114
|
|
Overall Study
NOT COMPLETED
|
14
|
53
|
53
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Smoking Cessation Self-Help for Dual Users of Tobacco Cigarettes and E-Cigarettes
Baseline characteristics by cohort
| Measure |
Assessment Only (ASSESS)
n=575 Participants
Participants in this condition will not receive any intervention materials. They will participate solely in the repeated assessments. Including this comparison condition controls for the effect of repeated assessments and allows for the most meaningful evaluation of the efficacy effect size as well as the cost-effectiveness of the eTARGET intervention. This condition will also be the primary source of data for the secondary surveillance aim regarding naturalistic changes in smoking and e-cigarette use over time.
|
Generic Self-Help (GENERIC)
n=1154 Participants
This will allow us to evaluate our novel self-help intervention for e-cigarette users (our If you Vape booklets) against a matched non-targeted intervention that has demonstrated efficacy for cigarette smokers in general. Such a comparison controls for the possibility that e-cigarette users are sufficiently primed to quit smoking and that even a generic, non-targeted intervention would be effective. This possibility will be directly tested by comparing this condition against both the ASSESS and eTARGET conditions in terms of clinical outcomes and cost-effectiveness.
GENERIC: The initial Stop Smoking for Good brochure, 10 Stop Smoking for Good booklets and 9 supportive My Story pamphlets delivered over 18 months, as used in our previous cessation study.
|
Targeted Self-Help (eTARGET)
n=1167 Participants
Participants in this condition will receive the intervention created as the product of Study I.
eTARGET: The product of Study I is expected to include the initial If You Vape brochure, a series of 10 If You Vape: Guide to Quitting Smoking booklets, distributed over 18 months, and 9 supportive My Story pamphlets, delivered in the months between booklets.
|
Total
n=2896 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
30 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
175 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
539 Participants
n=5 Participants
|
1073 Participants
n=7 Participants
|
1085 Participants
n=5 Participants
|
2697 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
207 Participants
n=5 Participants
|
435 Participants
n=7 Participants
|
424 Participants
n=5 Participants
|
1066 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
368 Participants
n=5 Participants
|
719 Participants
n=7 Participants
|
743 Participants
n=5 Participants
|
1830 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
65 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
241 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
510 Participants
n=5 Participants
|
1067 Participants
n=7 Participants
|
1078 Participants
n=5 Participants
|
2655 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
15 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
86 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
513 Participants
n=5 Participants
|
1012 Participants
n=7 Participants
|
1025 Participants
n=5 Participants
|
2550 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
27 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
148 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
575 participants
n=5 Participants
|
1154 participants
n=7 Participants
|
1167 participants
n=5 Participants
|
2896 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 18 months & 24 months post study enrollmentPercentage rate of smoking abstinence for participants who received If You Vape booklets, compared to: A) participants in an assessment-only condition; B) participants in a generic self-help condition comprising existing smoking cessation booklets.
Outcome measures
| Measure |
ASSESS at 18 Months
n=575 Participants
Participants in this condition did not receive any intervention materials.
|
ASSESS at 24 Months
n=575 Participants
Participants in this condition did not receive any intervention materials.
|
GENERIC at 18 Months
n=1154 Participants
This allowed investigators to evaluate their novel self-help intervention for e-cigarette users (our If you Vape booklets) against a matched non-targeted intervention that has demonstrated efficacy for cigarette smokers in general.
|
GENERIC at 24 Months
n=1154 Participants
This allowed investigators to evaluate their novel self-help intervention for e-cigarette users (our If you Vape booklets) against a matched non-targeted intervention that has demonstrated efficacy for cigarette smokers in general.
|
eTARGET at 18 Months
n=1167 Participants
Participants in this condition received the intervention the If You Vape brochure, a series of 10 If You Vape: Guide to Quitting Smoking booklets, distributed over 18 months, and 9 supportive My Story pamphlets, delivered in the months between booklets.
|
eTARGET at 24 Months
n=1167 Participants
Participants in this condition received the intervention the If You Vape brochure, a series of 10 If You Vape: Guide to Quitting Smoking booklets, distributed over 18 months, and 9 supportive My Story pamphlets, delivered in the months between booklets.
|
|---|---|---|---|---|---|---|
|
Rate of Smoking Abstinence
|
33 percentage of participants
|
40 percentage of participants
|
37 percentage of participants
|
42 percentage of participants
|
38 percentage of participants
|
42 percentage of participants
|
SECONDARY outcome
Timeframe: 18 and 24 months post study enrollmentPopulation: For this outcome measure, only the ASSESS group was analyzed for naturalistic changes in smoking and e-cigarette use over time.
As a surveillance study, investigators will track changes in the use of both tobacco cigarettes and e-cigarettes over time for ASSESS group only
Outcome measures
| Measure |
ASSESS at 18 Months
n=575 Participants
Participants in this condition did not receive any intervention materials.
|
ASSESS at 24 Months
n=575 Participants
Participants in this condition did not receive any intervention materials.
|
GENERIC at 18 Months
n=575 Participants
This allowed investigators to evaluate their novel self-help intervention for e-cigarette users (our If you Vape booklets) against a matched non-targeted intervention that has demonstrated efficacy for cigarette smokers in general.
|
GENERIC at 24 Months
n=575 Participants
This allowed investigators to evaluate their novel self-help intervention for e-cigarette users (our If you Vape booklets) against a matched non-targeted intervention that has demonstrated efficacy for cigarette smokers in general.
|
eTARGET at 18 Months
Participants in this condition received the intervention the If You Vape brochure, a series of 10 If You Vape: Guide to Quitting Smoking booklets, distributed over 18 months, and 9 supportive My Story pamphlets, delivered in the months between booklets.
|
eTARGET at 24 Months
Participants in this condition received the intervention the If You Vape brochure, a series of 10 If You Vape: Guide to Quitting Smoking booklets, distributed over 18 months, and 9 supportive My Story pamphlets, delivered in the months between booklets.
|
|---|---|---|---|---|---|---|
|
Changes in the Use of Tobacco Products
|
33 percentage of participants
|
40 percentage of participants
|
27 percentage of participants
|
32 percentage of participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 18 months and 24 months after study recruitmentPopulation: Participant groups evaluated at 18 and 24 months
Cost per incremental cessation will be measured using USD spent on the self help materials provided to the participants in the Generic and eTarget groups at 18 months and 24 months. \*\*\*Total cost was calculated for the intervention and not calculated as per participant cost
Outcome measures
| Measure |
ASSESS at 18 Months
n=575 Participants
Participants in this condition did not receive any intervention materials.
|
ASSESS at 24 Months
n=575 Participants
Participants in this condition did not receive any intervention materials.
|
GENERIC at 18 Months
n=1154 Participants
This allowed investigators to evaluate their novel self-help intervention for e-cigarette users (our If you Vape booklets) against a matched non-targeted intervention that has demonstrated efficacy for cigarette smokers in general.
|
GENERIC at 24 Months
n=1154 Participants
This allowed investigators to evaluate their novel self-help intervention for e-cigarette users (our If you Vape booklets) against a matched non-targeted intervention that has demonstrated efficacy for cigarette smokers in general.
|
eTARGET at 18 Months
n=1167 Participants
Participants in this condition received the intervention the If You Vape brochure, a series of 10 If You Vape: Guide to Quitting Smoking booklets, distributed over 18 months, and 9 supportive My Story pamphlets, delivered in the months between booklets.
|
eTARGET at 24 Months
n=1167 Participants
Participants in this condition received the intervention the If You Vape brochure, a series of 10 If You Vape: Guide to Quitting Smoking booklets, distributed over 18 months, and 9 supportive My Story pamphlets, delivered in the months between booklets.
|
|---|---|---|---|---|---|---|
|
Study 2: Cost Effectiveness
|
0 USD
|
0 USD
|
1535 USD
|
2369 USD
|
1000 USD
|
2253 USD
|
Adverse Events
Assessment Only (ASSESS)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Generic Self-Help (GENERIC)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Targeted Self-Help (eTARGET)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place