Smoking CessationNCT03575468
Enhanced E-cigarette Coaching Intervention for Dual Users of Cigarettes and E-cigarettes
A study testing Enhanced E-cigarette Coaching and Quitline treatment as usual in people with Smoking Cessation, run by Consumer Wellness Solutions at 1 site in United States.
Trial summary
The purpose of this study is to develop and pilot test an enhanced behavioral coaching intervention for dual users of cigarettes and electronic nicotine delivery systems (ENDS) who call tobacco quitlines for help quitting smoking. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Enhanced E-cigarette Coaching and Quitline treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2018to 1 Oct 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • Requested quitline coaching services and enrolled in 5 call Oklahoma Tobacco Helpline (OKHL) program
- Currently using e-cigarettes
- Indicated plan to use e-cigarettes in the next 30 days
- English Speaking
- 18+ years old
- Willing to quit cigarettes in the next 30 days
Show all 10Show fewer
- Consented to receive automated phone outreach via the quitline (TCPA consented)
- Has an Android smartphone with an operating system of 6.0 or higher and comfort downloading and using apps on phone
- Has regular access to email
- Callback best time between the hours of 6:00 am - 3:00 pm Pacific Standard Time
Who cannot join
- • Pregnant or Planning pregnancy within 3 months
- Reported Schizophrenia diagnosis history during registration
- Heart attack past 2 weeks
- Stroke/Transient Ischemic Attack past 2 weeks
- Rapid Irregular heart beat past 6 months
- Angina or heart pain past 6 months
Show all 9Show fewer
- Currently taking Varenicline (also known as Chantix) or Bupropion (also known as Wellbutrin or Zyban)
- Previously screened for study
- Enrolled via proxy (i.e., did not self-enroll)
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to develop and pilot test an enhanced behavioral coaching intervention for dual users of cigarettes and electronic nicotine delivery systems (ENDS) who call tobacco quitlines for help quitting smoking.
Read the detailed description
The specific aims of this research are to:
- Develop an Enhanced ENDS Coaching (EEC) intervention to improve standard quitline treatment for dual users who contact the quitline for help quitting smoking and are using ENDS, and train tobacco cessation coaches to deliver the intervention.
- Phase 1 (n=10): Assess preliminary EEC acceptability and feasibility, and refine the intervention with 10 dual users. Hypothesis 1: ENDS users will rate the helpfulness and usability of EEC positively and will exhibit increased knowledge about ENDS and cessation aids.
- Phase 2 (n=100): Evaluate the feasibility and acceptability of EEC compared to quitline treatment as usual (TAU) in a randomized pilot study of 100 smokers who use ENDS and are seeking help with quitting smoking. Hypothesis 2a (engagement): EEC participants will complete as many or more coaching calls than TAU. Hypothesis 2b (acceptability, satisfaction; assessed via 3-month survey): EEC will have satisfaction at least as high as the TAU group and rate their quit plan development experience more positively. Hypothesis 2c (beliefs; assessed at 3-month survey): EEC participants will report more accurate knowledge and beliefs about ENDS, smoking, and FDA-approved cessation medications.
- Conditions
- Smoking Cessation
- Being tested
- Enhanced E-cigarette Coaching, Quitline treatment as usual
- Keywords
- e-cigarette, vaping, electronic nicotine delivery system (ENDS), smoking cessation
- Medical subject headings
- Smoking Cessation, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced E-cigarette CoachingBehavioural
Also called 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.
Quitline treatment as usualBehavioural
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced E-cigarette Coaching (EEC) | Experimental | 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. Receives: Behavioral: Enhanced E-cigarette Coaching |
| Quitline treatment as usual (TAU) | Active comparator | 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. Receives: Behavioral: Quitline treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Satisfaction and Acceptability Measured on a Scale From 1-6 (Very Satisfied to Very Dissatisfied)
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.
Measured: 3 months after baseline
Treatment Engagement: Call Completion
In 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).
Measured: Phase 2 time frame: 3 months after baseline
Secondary outcomes (4)
Quit Plan Development Experience
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.
Measured: 3 months after baseline
Knowledge and Beliefs- Relative Risk of ENDS and Cigarettes
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.
Measured: Phase 2 time frame: 3 months after baseline
Knowledge and Beliefs- Relative Risk of FDA-approved Cessation Medications and Cigarettes
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.
Measured: Phase 2 time frame: 3 months after baseline
Knowledge and Beliefs- Relative Risk of FDA-approved Cessation Medications and ENDS
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.
Measured: Phase 2 time frame: 3 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2018
- Study start7 May 2018
- Primary completion31 Aug 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Consumer Wellness Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Oklahoma, SRI International, H. Lee Moffitt Cancer Center and Research Institute
- Responsible party
- Sponsor
- Investigators
- Katrina Vickerman, PHD, Principal investigator, Optum, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03575468
- Sponsor's protocol ID
- 1R21DA042960-01A1
- Status last verified
- Oct 2023
- First submitted
- 31 May 2018
- Last updated
- 16 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vickerman KA, Carpenter KM, Miles LN, Hsu JM, Watt KA, Brandon TH, Hart JT, Javitz HS, Wagener TL. Treatment development, implementation, and participant baseline characteristics: A randomized pilot study of a tailored quitline intervention for individuals who smoke and vape. Contemp Clin Trials Commun. 2021 Sep 8;24:100845. doi: 10.1016/j.conctc.2021.100845. eCollection 2021 Dec.
PubMed 34568637
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced E-cigarette Coaching Intervention for Dual Users of Cigarettes and E-cigarettes
- ClinicalTrials.gov ID
- NCT03575468
- Acronym / sponsor ID
- 1R21DA042960-01A1
- Conditions
- Smoking Cessation
- Keywords
- e-cigarette, vaping, electronic nicotine delivery system (ENDS), smoking cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Consumer Wellness SolutionsIndustry (pharma, biotech, devices)
- Collaborators
- University of Oklahoma, SRI International, H. Lee Moffitt Cancer Center and Research Institute
- Study start
- 7 May 2018 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 2 Jul 2018 (actual)
- Results
- Posted 10 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to develop and pilot test an enhanced behavioral coaching intervention for dual users of cigarettes and electronic nicotine delivery systems (ENDS) who call tobacco quitlines for help quitting smoking.
Detailed description
The specific aims of this research are to:
- Develop an Enhanced ENDS Coaching (EEC) intervention to improve standard quitline treatment for dual users who contact the quitline for help quitting smoking and are using ENDS, and train tobacco cessation coaches to deliver the intervention.
- Phase 1 (n=10): Assess preliminary EEC acceptability and feasibility, and refine the intervention with 10 dual users. Hypothesis 1: ENDS users will rate the helpfulness and usability of EEC positively and will exhibit increased knowledge about ENDS and cessation aids.
- Phase 2 (n=100): Evaluate the feasibility and acceptability of EEC compared to quitline treatment as usual (TAU) in a randomized pilot study of 100 smokers who use ENDS and are seeking help with quitting smoking. Hypothesis 2a (engagement): EEC participants will complete as many or more coaching calls than TAU. Hypothesis 2b (acceptability, satisfaction; assessed via 3-month survey): EEC will have satisfaction at least as high as the TAU group and rate their quit plan development experience more positively. Hypothesis 2c (beliefs; assessed at 3-month survey): EEC participants will report more accurate knowledge and beliefs about ENDS, smoking, and FDA-approved cessation medications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced E-cigarette Coaching (EEC) | Experimental | Behavioral: Enhanced E-cigarette CoachingThe 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) | Active comparator | Behavioral: Quitline treatment as usualThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- • Requested quitline coaching services and enrolled in 5 call Oklahoma Tobacco Helpline (OKHL) program
Key exclusion criteria (9 listed)
- • Pregnant or Planning pregnancy within 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced E-cigarette CoachingAlso: EECThe 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. | Behavioural | Enhanced E-cigarette Coaching (EEC) |
| Quitline treatment as usualAlso: TAUThe 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. | Behavioural | Quitline treatment as usual (TAU) |
Primary outcome
Treatment Satisfaction and Acceptability Measured on a Scale From 1-6 (Very Satisfied to Very Dissatisfied)
Time frame: 3 months after baseline
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.
Treatment Engagement: Call Completion
Time frame: Phase 2 time frame: 3 months after baseline
In 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).
4 secondary outcomes
Quit Plan Development Experience
Time frame: 3 months after baseline
Knowledge and Beliefs- Relative Risk of ENDS and Cigarettes
Time frame: Phase 2 time frame: 3 months after baseline
Knowledge and Beliefs- Relative Risk of FDA-approved Cessation Medications and Cigarettes
Time frame: Phase 2 time frame: 3 months after baseline
Knowledge and Beliefs- Relative Risk of FDA-approved Cessation Medications and ENDS
Time frame: Phase 2 time frame: 3 months after baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 34568637Vickerman KA, Carpenter KM, Miles LN, Hsu JM, Watt KA, Brandon TH, Hart JT, Javitz HS, Wagener TL. Treatment development, implementation, and participant baseline characteristics: A randomized pilot study of a tailored quitline intervention for individuals who smoke and vape. Contemp Clin Trials Commun. 2021 Sep 8;24:100845. doi: 10.1016/j.conctc.2021.100845. eCollection 2021 Dec.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katrina Vickerman, PHD principal investigator
Optum, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced E-cigarette Coaching and Quitline treatment as usual in people with Smoking Cessation, run by Consumer Wellness Solutions at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Satisfaction and Acceptability Measured on a Scale From 1-6 (Very Satisfied to Very Dissatisfied) (time frame: 3 months after baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03575468, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2023.