Smoking Cessation Clinical Trial
— E-STOPOfficial 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.
Status | Recruiting |
Enrollment | 672 |
Est. completion date | December 31, 2026 |
Est. primary completion date | December 31, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. current smoking, defined as 5+ 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: 1) Use of an FDA-approved cessation medication in the last 7 days |
Country | Name | City | State |
---|---|---|---|
United States | Medical University of South Carolina | Charleston | South Carolina |
Lead Sponsor | Collaborator |
---|---|
Medical University of South Carolina | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants who utilized smoking cessation treatment | Number of participants who utilized smoking cessation treatment since last assessment. | Month 1 | |
Primary | Number of participants who utilized smoking cessation treatment | Number of participants who utilized smoking cessation treatment since last assessment. | Month 3 | |
Primary | Number of participants who utilized smoking cessation treatment | Number of participants who utilized smoking cessation treatment since last assessment. | Month 6 | |
Primary | Cigarettes smoking | Cigarettes per day reduction greater than 50% | Month 1 | |
Primary | Cigarettes smoking | Cigarettes per day reduction greater than 50% | Month 3 | |
Primary | Cigarettes smoking | Cigarettes per day reduction greater than 50% | Month 6 | |
Primary | Quit attempts | Quit attempts since last contact | Month 1 | |
Primary | Quit attempts | Quit attempts since last contact | Month 3 | |
Primary | Quit attempts | Quit attempts since last contact | Month 6 | |
Primary | Seven-day point prevalence abstinence | Participant has not had a cigarette in the past 7 days | Month 1 | |
Primary | Seven-day point prevalence abstinence | Participant has not had a cigarette in the past 7 days | Month 3 | |
Primary | Seven-day point prevalence abstinence | Participant has not had a cigarette in the past 7 days | Month 6 | |
Primary | 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. | Month 1 | |
Primary | 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. | Month 3 | |
Primary | 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. | Month 6 | |
Primary | E-visit Adoption | Patients prescribed a medication who obtain their medication | Month 1 | |
Primary | E-visit Adoption | Patients prescribed a medication who obtain their medication | Month 3 | |
Primary | E-visit Adoption | Patients prescribed a medication who obtain their medication | Month 6 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04043728 -
Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study
|
N/A | |
Completed |
NCT03999411 -
Smartphone Intervention for Smoking Cessation and Improving Adherence to Treatment Among HIV Patients
|
Phase 4 | |
Completed |
NCT04617444 -
The ESTxENDS Trial- Substudy on Effects of Using Electronic Nicotine Delivery Systems (ENDS) on Olfactory Function
|
N/A | |
Completed |
NCT02796391 -
Facilitating Smoking Cessation With Reduced Nicotine Cigarettes
|
Phase 2 | |
Completed |
NCT03397511 -
Incorporating Financial Incentives to Increase Smoking Cessation Among Asian Americans Residing in New York City
|
N/A | |
Not yet recruiting |
NCT05188287 -
A Culturally Tailored Smartphone Application for African American Smokers
|
N/A | |
Recruiting |
NCT05264428 -
The Effect of Honey on Lessening the Withdrawal Symptoms
|
N/A | |
Recruiting |
NCT05846841 -
Personalized Tobacco Treatment in Primary Care (MOTIVATE)
|
N/A | |
Completed |
NCT04133064 -
Assessment of the Pivot Breath Sensor: Single-Arm Cohort Study
|
N/A | |
Completed |
NCT03187730 -
Integrating Financial Management Counseling and Smoking Cessation Counseling to Reduce Health and Economic Disparities in Low-Income Immigrants
|
Phase 4 | |
Completed |
NCT03474783 -
To Explore the Factors Affecting the Effectiveness of Smoking Cessation
|
N/A | |
Completed |
NCT04635358 -
Feasibility Study of Smoking Cessation for the Staff of a Hospital Center
|
N/A | |
Terminated |
NCT03670264 -
BE Smokefree: Behavioral Economics Incentives to Engage Adolescents in Smoking Cessation
|
N/A | |
Not yet recruiting |
NCT06307496 -
VIDeOS for Smoking Cessation
|
N/A | |
Completed |
NCT02905656 -
Strategies to Promote Cessation in Smokers Who Are Not Ready To Quit
|
N/A | |
Completed |
NCT02997657 -
Positive Psychotherapy for Smoking Cessation Enhanced With Text Messaging: A Randomized Controlled Trial
|
N/A | |
Completed |
NCT03206619 -
A Health Recommeder System to Tailor Message Preferences in a Smoking Cessation Programme
|
||
Completed |
NCT02239770 -
Pharmacokinetics of Nicotine Film in Smokers
|
N/A | |
Completed |
NCT02562521 -
A Smoking Cessation Intervention for Yale Dining Employees
|
Phase 4 | |
Recruiting |
NCT02422914 -
Benefits of Tobacco Free Cigarette
|
N/A |