Smoking Cessation Self-Help for Dual Users of Tobacco Cigarettes and E-Cigarettes

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT02416011
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH), National Institutes of Health (NIH) (NIH)
• Enrollment: 2,896
• Location: 1
• Arms: 3
• Actual Duration (Months): 51
• Patients Per Site Per Month: 56.8

Study Details

Study Description

Brief Summary

The purpose of this study is to develop and test a series of booklets designed to assist smokers of tobacco cigarettes who are also using e-cigarettes (dual users) in quitting smoking and remaining smoke-free.

Condition or Disease	Intervention/Treatment	Phase
Smoking Cessation	Behavioral: GENERIC; Behavioral: eTARGET	N/A

Detailed Description

The first two aims of the present proposal are to adapt a validated self-help, smoking-cessation intervention to meet the needs of current dual users, and to test this new intervention in a randomized controlled trial (RCT). A third primary aim is to calculate the cost-effectiveness of the intervention. A secondary aim is to gather longitudinal data regarding the patterns of tobacco and e-cigarette use and the course of cessation of either product among dual users.

Specific Aim 1. To create a minimal smoking-cessation intervention for current dual users of tobacco cigarettes and e-cigarettes (Study I). The intervention will comprise a series of booklets and pamphlets modeled after the Forever Free booklets found to be successful at producing long-term abstinence among the general population of smokers, but adapted to the special needs, circumstances, and risk factors of dual users.

Validated methodologies used for adapting the intervention mirror those used in our prior smoking cessation studies, and reflect systematic approaches across two-phases informed by individual interviews and learner verification methodologies. The intervention will provide assistance for smoking cessation, and also encourage users to taper and eventually terminate their e-cigarette use as per traditional nicotine replacement therapy (NRT). The end product of Study I will be a series of booklets tentatively titled, "If You Vape: Guide to Quitting Smoking," available both in printed and electronic formats.

Specific Aim 2. To evaluate the efficacy of the intervention via a randomized, controlled clinical trial of current dual users (Study II). We will compare the intervention developed under Specific Aim 1 with both an assessment-only condition and a generic self-help condition comprising existing smoking cessation booklets. We hypothesize that recipients of our targeted If You Vape booklets will show higher rates of tobacco abstinence at 6, 12, 18, and 24 months after enrollment, as compared to both comparison conditions. A secondary hypothesis is that the new intervention will produce higher rates of abstinence from e-cigarettes themselves. To identify mechanism of change, we will also test several a priori moderator and mediator variables, including gender, socio-economic status, motivation to quit, nicotine dependence, e-cigarette expectancies, and magnitude of e-cigarette use (frequency, dosage).

Specific Aim 3. To calculate and compare the cost-effectiveness of the interventions. Cost- effectiveness data are vital for evaluating the real-world feasibility of an intervention. Small improvements in treatment efficacy may not be justified if they require substantially greater cost. We will compare the interventions not only on outcome efficacy, but on cost-effectiveness with respect to cost per incremental cessation and expected life-years saved.

Study Design

• Study Type: Interventional
• Actual Enrollment: 2896 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Smoking Cessation Self-Help for Dual Users of Tobacco Cigarettes and E-Cigarettes
• Actual Study Start Date: Mar 31, 2015
• Actual Primary Completion Date: Jun 30, 2019
• Actual Study Completion Date: Jun 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: 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.
Active Comparator: 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.	Behavioral: 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.; Other Names: self-help
Experimental: Targeted Self-Help (eTARGET) Participants in this condition will receive the intervention created as the product of Study I.	Behavioral: 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.; Other Names: self-help

Outcome Measures

Primary Outcome Measures

1. Rate of Smoking Abstinence [18 months & 24 months post study enrollment]

   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.

Secondary Outcome Measures

1. Changes in the Use of Tobacco Products [18 and 24 months post study enrollment]

   As a surveillance study, investigators will track changes in the use of both tobacco cigarettes and e-cigarettes over time for ASSESS group only

Other Outcome Measures

1. Study 2: Cost Effectiveness [18 months and 24 months after study recruitment]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Study I - First Phase - No Longer Recruiting

• Greater than 1 year history of daily smoking

• 1 month or more of e-cigarette use

• Able to speak and read English

• (1) current dual users (of tobacco cigarettes and e-cigarettes) without interest in quitting smoking; (2) current dual users who have attempted, but not quit smoking; (3) current e-cigarette users who have successfully quit smoking; and (4) former dual users who have quit both products.

• Study I - Second Phase - No Longer Recruiting

• Current dual users (of tobacco cigarettes and e-cigarettes)

• Smoking at least one cigarette per day over the past year

• Using e-cigarettes at least once per week over the past month

• Not currently enrolled in a face-to-face smoking cessation program

• Able to speak and read English

• Study II - No Longer Recruiting

• Current dual users (of tobacco cigarettes and e-cigarettes)

• Smoking at least one cigarette per week over the past year

• Using e-cigarettes at least once per week over the past month

• Not currently enrolled in a face-to-face smoking cessation program

• Able to speak and read English

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida	United States	33612

Sponsors and Collaborators

• H. Lee Moffitt Cancer Center and Research Institute
• National Institute on Drug Abuse (NIDA)
• National Institutes of Health (NIH)

Investigators

• Principal Investigator: Thomas Brandon, Ph.D., H. Lee Moffitt Cancer Center and Research Institute

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 20, 2018

More Information

Additional Information:

• Moffitt Cancer Center Clinical Trials website

Publications

None provided.

• Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
• ClinicalTrials.gov Identifier: NCT02416011
• Other Study ID Numbers: MCC-18127; R01DA037961-01A1
• First Posted: Apr 14, 2015
• Last Update Posted: Feb 23, 2022
• Last Verified: Feb 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by H. Lee Moffitt Cancer Center and Research Institute: e-cigarette; nicotine dependence

Study Results

Participant Flow

Arm/Group Title	Assessment Only (ASSESS)	Generic Self-Help (GENERIC)	Targeted Self-Help (eTARGET)
Arm/Group Description	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.	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.	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.
Period Title: Overall Study
STARTED	575	1154	1167
COMPLETED	561	1101	1114
NOT COMPLETED	14	53	53

Baseline Characteristics

Arm/Group Title	Assessment Only (ASSESS)	Generic Self-Help (GENERIC)	Targeted Self-Help (eTARGET)	Total
Arm/Group Description	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.	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.	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 of all reporting groups
Overall Participants	575	1154	1167	2896
Age (Count of Participants)
<=18 years	30 5.2%	69 6%	76 6.5%	175 6%
Between 18 and 65 years	539 93.7%	1073 93%	1085 93%	2697 93.1%
>=65 years	6 1%	12 1%	6 0.5%	24 0.8%
Sex: Female, Male (Count of Participants)
Female	207 36%	435 37.7%	424 36.3%	1066 36.8%
Male	368 64%	719 62.3%	743 63.7%	1830 63.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	65 11.3%	87 7.5%	89 7.6%	241 8.3%
Not Hispanic or Latino	510 88.7%	1067 92.5%	1078 92.4%	2655 91.7%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	15 2.6%	27 2.3%	11 0.9%	53 1.8%
Asian	5 0.9%	9 0.8%	9 0.8%	23 0.8%
Native Hawaiian or Other Pacific Islander	3 0.5%	8 0.7%	7 0.6%	18 0.6%
Black or African American	10 1.7%	35 3%	41 3.5%	86 3%
White	513 89.2%	1012 87.7%	1025 87.8%	2550 88.1%
More than one race	27 4.7%	57 4.9%	64 5.5%	148 5.1%
Unknown or Not Reported	2 0.3%	6 0.5%	10 0.9%	18 0.6%
Region of Enrollment (participants) [Number]
United States	575 100%	1154 100%	1167 100%	2896 100%

Outcome Measures

1. Primary Outcome

Title	Rate of Smoking Abstinence
Description	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.
Time Frame	18 months & 24 months post study enrollment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ASSESS at 18 Months	ASSESS at 24 Months	GENERIC at 18 Months	GENERIC at 24 Months	eTARGET at 18 Months	eTARGET at 24 Months
Arm/Group Description	Participants in this condition did not receive any intervention materials.	Participants in this condition did not receive any intervention materials.	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.	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.	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.	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.
Measure Participants	575	575	1154	1154	1167	1167
Number [percentage of participants]	33 5.7%	40 3.5%	37 3.2%	42 1.5%	38 NaN	42 NaN

2. Secondary Outcome

Title	Changes in the Use of Tobacco Products
Description	As a surveillance study, investigators will track changes in the use of both tobacco cigarettes and e-cigarettes over time for ASSESS group only
Time Frame	18 and 24 months post study enrollment

Outcome Measure Data

Analysis Population Description

For this outcome measure, only the ASSESS group was analyzed for naturalistic changes in smoking and e-cigarette use over time.

Arm/Group Title	Asses Cigarette Use at 18 Months	ASSESS Cigarette Use at 24 Months	ASSES Vaping at 18 Months	ASSESS Vaping at 24 Months
Arm/Group Description	Participants in this condition did not receive any intervention	Participants in this condition did not receive any intervention materials.	Participants in this condition did not receive any intervention	Participants in this condition did not receive any intervention materials.
Measure Participants	575	575	575	575
Number [percentage of participants]	33 5.7%	40 3.5%	27 2.3%	32 1.1%

3. Other Pre-specified Outcome

Title	Study 2: Cost Effectiveness
Description	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
Time Frame	18 months and 24 months after study recruitment

Outcome Measure Data

Analysis Population Description

Participant groups evaluated at 18 and 24 months

Arm/Group Title	ASSESS Group at 18 Months	ASSESS Group at 24 Months	GENERIC Group at 18 Months	GENERIC Group at 24 Months	eTARGET Group at 18 Months	eTarget Group at 24 Months
Arm/Group Description	Participants in this condition did not receive any intervention materials	Participants in this condition did not receive any intervention	This group allowed investigators to evaluate their novel self-help intervention for e-cigarette users (If you Vape booklets) against a matched non-targeted intervention that has demonstrated efficacy for cigarette smokers in general.	This group allowed investigators to evaluate their novel self-help intervention for e-cigarette users (If you Vape booklets) against a matched non-targeted intervention that has demonstrated efficacy for cigarette smokers in general.	Participants in this condition received the intervention; 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.	Participants in this condition received the intervention; 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.
Measure Participants	575	575	1154	1154	1167	1167
Number [USD]	0	0	1535	2369	1000	2253

Adverse Events

Time Frame	Adverse Events were not collected
Adverse Event Reporting Description	Participants were not given any type of drug. The intervention participants received was the If You Vape brochure, a series of 10 If You Vape: Guide to Quitting Smoking booklets and 9 supportive My Story pamphlets
Arm/Group Title	Assessment Only (ASSESS)		Generic Self-Help (GENERIC)		Targeted Self-Help (eTARGET)
Arm/Group Description	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.		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.		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.
All Cause Mortality
	Assessment Only (ASSESS)		Generic Self-Help (GENERIC)		Targeted Self-Help (eTARGET)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	Assessment Only (ASSESS)		Generic Self-Help (GENERIC)		Targeted Self-Help (eTARGET)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Assessment Only (ASSESS)		Generic Self-Help (GENERIC)		Targeted Self-Help (eTARGET)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.