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NCT Number: NCT05493254

Enhancing Smoking Cessation Via Telehealth Options in 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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location status: Recruiting

Location contact

Noelle Natale

CONTACT

[email protected]

843-876-2426

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Smoking cessation e-visit

Behavioral

electronic visits (e-visits) for smoking cessation

Treatment as Usual

Behavioral

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.

Primary outcomes

  1. Number of participants who utilized smoking cessation treatment

    Time frame: Month 1

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

  2. Number of participants who utilized smoking cessation treatment

    Time frame: Month 3

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

  3. Number of participants who utilized smoking cessation treatment

    Time frame: Month 6

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

  4. Cigarettes smoking

    Time frame: Month 1

    Cigarettes per day reduction greater than 50%

  5. Cigarettes smoking

    Time frame: Month 3

    Cigarettes per day reduction greater than 50%

  6. Cigarettes smoking

    Time frame: Month 6

    Cigarettes per day reduction greater than 50%

  7. Quit attempts

    Time frame: Month 1

    Quit attempts since last contact

  8. Quit attempts

    Time frame: Month 3

    Quit attempts since last contact

  9. Quit attempts

    Time frame: Month 6

    Quit attempts since last contact

  10. Seven-day point prevalence abstinence

    Time frame: Month 1

    Participant has not had a cigarette in the past 7 days

  11. Seven-day point prevalence abstinence

    Time frame: Month 3

    Participant has not had a cigarette in the past 7 days

  12. Seven-day point prevalence abstinence

    Time frame: Month 6

    Participant has not had a cigarette in the past 7 days

  13. 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.

  14. 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.

  15. 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.

  16. E-visit Adoption

    Time frame: Month 1

    Patients prescribed a medication who obtain their medication

  17. E-visit Adoption

    Time frame: Month 3

    Patients prescribed a medication who obtain their medication

  18. E-visit Adoption

    Time frame: Month 6

    Patients prescribed a medication who obtain their medication

Study contacts

Contact information is provided by the study sponsor or research team.

Noelle E Natale

CONTACT

[email protected]

843-876-2426

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Hybrid Type 1 Effectiveness-Implementation Trial of a Proactive Smoking Cessation Electronic Visit for Scalable Delivery Via Primary Care

Acronym: E-STOP

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Aug 9, 2022
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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