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RecruitingNCT05493254E-STOPUpdated Mar 5, 2026

Enhancing Smoking Cessation Via Telehealth Options in Primary Care

An interventional study of Smoking cessation e-visit and Treatment As Usual in Smoking Cessation, sponsored by Medical University of South Carolina. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-05.

Sponsored by Medical University of South Carolina · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Started Aug 2022; still recruiting 4 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
672
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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. 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.

02

Conditions studied

  • Smoking Cessation

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03

In context

Smoking Cessation

304 studies on the registry are indexed under Smoking Cessation; 139 are open to participants now.

This study's planned enrollment of 672 is above the median of 154 across 285 interventional studies indexed under Smoking Cessation.

Browse Smoking Cessation studies →

Lead sponsor

Medical University of South Carolina is the lead sponsor of 852 studies on the registry; 165 are open to participants now.

Of its 128 completed or terminated interventional studies of FDA-regulated products, 101 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. current smoking, defined as 1+ cigarettes/day, for 20+ days out of the last 30 for the last 6+ months
  2. age 18+
  3. enrolled in MyChart or willing to enroll
  4. possess a valid e-mail address that is checked daily
  5. owner of an iOS or Android smartphone to provide remote CO
  6. have a valid mailing address
  7. English fluency

Exclusion criteria

Exclusion Criteria:

1) Use of an FDA-approved cessation medication in the last 7 days

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
672 participants (estimated)

Study arms

  • Experimental
    Smoking cessation electronic visit (e-visit)

    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.

    Behavioral: Smoking cessation e-visit

  • Active comparator
    Treatment as usual (TAU)

    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.

    Behavioral: Treatment As Usual

Interventions

  • BehavioralSmoking cessation e-visit

    electronic visits (e-visits) for smoking cessation

  • BehavioralTreatment As Usual

    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.

06

What researchers measure

Primary outcomes

  1. Number of participants who utilized smoking cessation treatment

    Number of participants who utilized smoking cessation treatment since last assessment.

    Time frame: Month 1

  2. Number of participants who utilized smoking cessation treatment

    Number of participants who utilized smoking cessation treatment since last assessment.

    Time frame: Month 3

  3. Number of participants who utilized smoking cessation treatment

    Number of participants who utilized smoking cessation treatment since last assessment.

    Time frame: Month 6

  4. Cigarettes smoking

    Cigarettes per day reduction greater than 50%

    Time frame: Month 1

  5. Cigarettes smoking

    Cigarettes per day reduction greater than 50%

    Time frame: Month 3

  6. Cigarettes smoking

    Cigarettes per day reduction greater than 50%

    Time frame: Month 6

  7. Quit attempts

    Quit attempts since last contact

    Time frame: Month 1

  8. Quit attempts

    Quit attempts since last contact

    Time frame: Month 3

  9. Quit attempts

    Quit attempts since last contact

    Time frame: Month 6

  10. Seven-day point prevalence abstinence

    Participant has not had a cigarette in the past 7 days

    Time frame: Month 1

  11. Seven-day point prevalence abstinence

    Participant has not had a cigarette in the past 7 days

    Time frame: Month 3

  12. Seven-day point prevalence abstinence

    Participant has not had a cigarette in the past 7 days

    Time frame: Month 6

  13. 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.

    Time frame: Month 1

  14. 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.

    Time frame: Month 3

  15. 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.

    Time frame: Month 6

  16. E-visit Adoption

    Patients prescribed a medication who obtain their medication

    Time frame: Month 1

  17. E-visit Adoption

    Patients prescribed a medication who obtain their medication

    Time frame: Month 3

  18. E-visit Adoption

    Patients prescribed a medication who obtain their medication

    Time frame: Month 6

07

Study locations

1 of 1 sites recruiting
  • Medical University of South Carolina
    Charleston, South Carolina 29425, United States
    Recruiting
08

References and documents

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 documents

  • Protocol and statistical analysis plan · Jul 25, 2022
  • Informed consent form · Jul 29, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05493254
Lead sponsor
Medical University of South Carolina
Collaborators
National Cancer Institute (NCI)
Responsible party
Jennifer Dahne (Associate Professor, Medical University of South Carolina) — Principal investigator
First posted
Aug 9, 2022
Start date
Aug 31, 2022
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Mar 5, 2026

Study contacts

Noelle E Natale
Contact
natalen@musc.edu
843-876-2426

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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