Smoking CessationE-STOPNCT05493254
Enhancing Smoking Cessation Via Telehealth Options in Primary Care
A study testing Smoking cessation e-visit and Treatment As Usual in people with Smoking Cessation, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The purpose of this research study is to evaluate an electronic visit (e-visit) for smoking cessation. Participants will be randomly assigned to receive either the smoking cessation e-visit or not. 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?
- Smoking cessation e-visit and Treatment As Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 672 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- current smoking, defined as 1+ cigarettes/day, for 20+ days out of the last 30 for the last 6+ months
- age 18+
- enrolled in MyChart or willing to enroll
- possess a valid e-mail address that is checked daily
- owner of an iOS or Android smartphone to provide remote CO
- have a valid mailing address
- English fluency
Who cannot join
- 1) Use of an FDA-approved cessation medication in the last 7 days
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Noelle Natale, 843-876-2426, natalen@musc.edu
About this study
Official title: Hybrid Type 1 Effectiveness-Implementation Trial of a Proactive Smoking Cessation Electronic Visit for Scalable Delivery Via Primary Care
The purpose of this research study is to evaluate an electronic visit (e-visit) for smoking cessation. Participants will be randomly assigned to receive either the smoking cessation e-visit or not. The e-visit will look similar to an online questionnaire asking about smoking history, motivation to quit, and preferences for medications for quitting smoking. Participants may receive a prescription for a smoking cessation medication as an outcome of the e-visit, if randomized to the e-visit group, but there is no requirement to take any medication. This study consists of questionnaires and breath samples provided at 4 separate time points throughout the study. Participation in this study will take about 24 weeks.
- Conditions
- Smoking Cessation
- Being tested
- Smoking cessation e-visit, Treatment As Usual
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking cessation e-visitBehavioural
electronic visits (e-visits) for smoking cessation
Treatment As UsualBehavioural
Information about the state quitline and about the importance of quitting smoking and a recommendation to contact one's PCP to schedule a medical visit to discuss quitting smoking.
| Study group | Role | What they receive |
|---|---|---|
| Smoking cessation electronic visit (e-visit) | Experimental | This group will be sent 1) an invitation to complete an electronic visit (e-visit) focused on cigarette smoking and 2) an invitation to complete a follow-up e-visit one-month after the initial e-visit. Receives: Behavioral: Smoking cessation e-visit |
| Treatment as usual (TAU) | Active comparator | This group will be provided information about the state quitline and about the importance of quitting smoking and it will be recommended that they contact their PCP to schedule a medical visit to discuss quitting smoking. Receives: Behavioral: Treatment As Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who utilized smoking cessation treatment
Number of participants who utilized smoking cessation treatment since last assessment.
Measured: Month 1
Number of participants who utilized smoking cessation treatment
Number of participants who utilized smoking cessation treatment since last assessment.
Measured: Month 3
Number of participants who utilized smoking cessation treatment
Number of participants who utilized smoking cessation treatment since last assessment.
Measured: Month 6
Cigarettes smoking
Cigarettes per day reduction greater than 50%
Measured: Month 1
Cigarettes smoking
Cigarettes per day reduction greater than 50%
Measured: Month 3
Cigarettes smoking
Cigarettes per day reduction greater than 50%
Measured: Month 6
Quit attempts
Quit attempts since last contact
Measured: Month 1
Quit attempts
Quit attempts since last contact
Measured: Month 3
Quit attempts
Quit attempts since last contact
Measured: Month 6
Seven-day point prevalence abstinence
Participant has not had a cigarette in the past 7 days
Measured: Month 1
Seven-day point prevalence abstinence
Participant has not had a cigarette in the past 7 days
Measured: Month 3
Seven-day point prevalence abstinence
Participant has not had a cigarette in the past 7 days
Measured: Month 6
E-visit Acceptability
The e-visit will be considered acceptable if the average score on the Acceptability of Intervention Measure (AIM) is greater than or equal to 4.
Measured: Month 1
E-visit Acceptability
The e-visit will be considered acceptable if the average score on the Acceptability of Intervention Measure (AIM) is greater than or equal to 4.
Measured: Month 3
E-visit Acceptability
The e-visit will be considered acceptable if the average score on the Acceptability of Intervention Measure (AIM) is greater than or equal to 4.
Measured: Month 6
E-visit Adoption
Patients prescribed a medication who obtain their medication
Measured: Month 1
E-visit Adoption
Patients prescribed a medication who obtain their medication
Measured: Month 3
E-visit Adoption
Patients prescribed a medication who obtain their medication
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start31 Aug 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 672 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Jennifer Dahne, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05493254
- Sponsor's protocol ID
- Pro00113308
- Other IDs
- R01CA258669
- Acronym
- E-STOP
- Status last verified
- Mar 2026
- First submitted
- 5 Aug 2022
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fahey MC, Wahlquist AE, Diaz VA, Player MS, Natale N, Sterba KR, Chen BK, Hermes EDA, Carpenter MJ, Dahne J. Rationale, design, and protocol for a hybrid type 1 effectiveness-implementation trial of a proactive smoking cessation electronic visit for scalable delivery via primary care: the E-STOP trial. BMC Prim Care. 2023 Nov 29;24(1):254. doi: 10.1186/s12875-023-02205-3.
PubMed 38030991
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hybrid Type 1 Effectiveness-Implementation Trial of a Proactive Smoking Cessation Electronic Visit for Scalable Delivery Via Primary Care
- ClinicalTrials.gov ID
- NCT05493254
- Acronym / sponsor ID
- E-STOP / Pro00113308
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 672 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 31 Aug 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Aug 2022 (actual)
- Results
- Not posted in the source record
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 research study is to evaluate an electronic visit (e-visit) for smoking cessation. Participants will be randomly assigned to receive either the smoking cessation e-visit or not. The e-visit will look similar to an online questionnaire asking about smoking history, motivation to quit, and preferences for medications for quitting smoking. Participants may receive a prescription for a smoking cessation medication as an outcome of the e-visit, if randomized to the e-visit group, but there is no requirement to take any medication. This study consists of questionnaires and breath samples provided at 4 separate time points throughout the study. Participation in this study will take about 24 weeks.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smoking cessation electronic visit (e-visit) | Experimental | Behavioral: Smoking cessation e-visitThis group will be sent 1) an invitation to complete an electronic visit (e-visit) focused on cigarette smoking and 2) an invitation to complete a follow-up e-visit one-month after the initial e-visit. |
| Treatment as usual (TAU) | Active comparator | Behavioral: Treatment As UsualThis group will be provided information about the state quitline and about the importance of quitting smoking and it will be recommended that they contact their PCP to schedule a medical visit to discuss quitting smoking. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- current smoking, defined as 1+ cigarettes/day, for 20+ days out of the last 30 for the last 6+ months
- age 18+
- enrolled in MyChart or willing to enroll
- possess a valid e-mail address that is checked daily
- owner of an iOS or Android smartphone to provide remote CO
Key exclusion criteria (1 listed)
- 1) Use of an FDA-approved cessation medication in the last 7 days
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 |
|---|---|---|
| Smoking cessation e-visitelectronic visits (e-visits) for smoking cessation | Behavioural | Smoking cessation electronic visit (e-visit) |
| Treatment As UsualInformation about the state quitline and about the importance of quitting smoking and a recommendation to contact one's PCP to schedule a medical visit to discuss quitting smoking. | Behavioural | Treatment as usual (TAU) |
Primary outcome
Number of participants who utilized smoking cessation treatment
Time frame: Month 1
Number of participants who utilized smoking cessation treatment since last assessment.
Number of participants who utilized smoking cessation treatment
Time frame: Month 3
Number of participants who utilized smoking cessation treatment since last assessment.
Number of participants who utilized smoking cessation treatment
Time frame: Month 6
Number of participants who utilized smoking cessation treatment since last assessment.
Cigarettes smoking
Time frame: Month 1
Cigarettes per day reduction greater than 50%
Cigarettes smoking
Time frame: Month 3
Cigarettes per day reduction greater than 50%
Cigarettes smoking
Time frame: Month 6
Cigarettes per day reduction greater than 50%
Quit attempts
Time frame: Month 1
Quit attempts since last contact
Quit attempts
Time frame: Month 3
Quit attempts since last contact
Quit attempts
Time frame: Month 6
Quit attempts since last contact
Seven-day point prevalence abstinence
Time frame: Month 1
Participant has not had a cigarette in the past 7 days
Seven-day point prevalence abstinence
Time frame: Month 3
Participant has not had a cigarette in the past 7 days
Seven-day point prevalence abstinence
Time frame: Month 6
Participant has not had a cigarette in the past 7 days
E-visit Acceptability
Time frame: Month 1
The e-visit will be considered acceptable if the average score on the Acceptability of Intervention Measure (AIM) is greater than or equal to 4.
E-visit Acceptability
Time frame: Month 3
The e-visit will be considered acceptable if the average score on the Acceptability of Intervention Measure (AIM) is greater than or equal to 4.
E-visit Acceptability
Time frame: Month 6
The e-visit will be considered acceptable if the average score on the Acceptability of Intervention Measure (AIM) is greater than or equal to 4.
E-visit Adoption
Time frame: Month 1
Patients prescribed a medication who obtain their medication
E-visit Adoption
Time frame: Month 3
Patients prescribed a medication who obtain their medication
E-visit Adoption
Time frame: Month 6
Patients prescribed a medication who obtain their medication
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Derived from this study: PubMed 38030991Fahey MC, Wahlquist AE, Diaz VA, Player MS, Natale N, Sterba KR, Chen BK, Hermes EDA, Carpenter MJ, Dahne J. Rationale, design, and protocol for a hybrid type 1 effectiveness-implementation trial of a proactive smoking cessation electronic visit for scalable delivery via primary care: the E-STOP trial. BMC Prim Care. 2023 Nov 29;24(1):254. doi: 10.1186/s12875-023-02205-3.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smoking cessation e-visit and Treatment As Usual in people with Smoking Cessation, run by Medical University of South Carolina 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 7 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 5 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Noelle E Natale (843-876-2426, natalen@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who utilized smoking cessation treatment (time frame: Month 1). The study lists 18 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 NCT05493254, 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 5 Mar 2026.