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| Name | Class |
|---|---|
| University of Massachusetts, Boston | OTHER |
| Dana-Farber Cancer Institute | OTHER |
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This study investigates the feasibility, acceptability, and short-term effects of providing 4 weeks of complimentary electronic cigarettes (ECs) to 30 individuals who did not quit after smoking cessation treatment provided in the context of lung cancer screening and do not plan to quit smoking. This open-label single-arm pilot clinical trial will test the impact of EC provision on: 1) study feasibility, 2) EC acceptability, 3) tobacco use behavior (e.g., cigarettes per day, EC use), and 4) biomarkers (e.g., carbon monoxide, cotinine, and anabasine). Participants will be asked to switch from combustible cigarettes to the NJOY ACE 5% nicotine electronic cigarette (EC) for 4 weeks. They will be followed an additional 4 weeks after EC provision ends (to 8 weeks).
The first study hypothesis is that more than 40% of eligible smokers who are offered participation in the trial will enroll, and that 75% of enrollees will complete the trial. The second study hypothesis is that participants will report fewer cigarettes smoked per day at the end of 4 weeks of EC provision, relative to their baseline values.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NJOY ACE e-cigarette provision | Experimental | Device: NJOY ACE e-cigarette, 5% nicotine in tobacco flavor Patients will be provided with a NJOY ACE electronic cigarette for 4 weeks and asked to use the NJOY ACE as a substitute for smoking combustible cigarettes during the 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NJOY ACE e-cigarette | Other | Patients will be provided with NJOY ACE electronic cigarettes and 5% nicotine e-liquid cartridges in tobacco flavor for 4 weeks and asked to use the electronic cigarette as a substitute for smoking combustible cigarettes during the 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Study Feasibility | Participant enrollment, measured by the proportion of eligible participants who enroll in the study. Retention is measured by weeks of study participation. | 4 weeks |
| Cigarettes Per Day (CPD) Smoked During the Period of E-cigarette Provision | Change in self-reported CPD smoked in the past week assessed using timeline follow-back (TLFB) between baseline and end of e-cigarette provision (Baseline vs.Week 4) | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Carbon Monoxide (CO) Concentration in Expired Air | Change in participant's expired air carbon monoxide (CO) concentration assessed via Smokerlyzer during the period of e-cigarette provision (Baseline vs.week 4) | 4 weeks |
| Cigarettes Smoked Per Day After E-cigarette Provision Ends |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nancy A. Rigotti, MD | Massachusetts General Hospital | Principal Investigator |
| Jaqueline C Avila, PhD | University of Massachusetts, Boston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | NJOY ACE E-cigarette Provision | Device: NJOY ACE e-cigarette, 5% nicotine in tobacco flavor Patients will be provided with a NJOY ACE electronic cigarette for 4 weeks and asked to use the NJOY ACE as a substitute for smoking combustible cigarettes during the 4 weeks. NJOY ACE e-cigarette: Patients will be provided with NJOY ACE electronic cigarettes and 5% nicotine e-liquid cartridges in tobacco flavor for 4 weeks and asked to use the electronic cigarette as a substitute for smoking combustible cigarettes during the 4 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | NJOY ACE E-cigarette Provision | Device: NJOY ACE e-cigarette, 5% nicotine in tobacco flavor Patients will be provided with a NJOY ACE electronic cigarette for 4 weeks and asked to use the NJOY ACE as a substitute for smoking combustible cigarettes during the 4 weeks. NJOY ACE e-cigarette: Patients will be provided with NJOY ACE electronic cigarettes and 5% nicotine e-liquid cartridges in tobacco flavor for 4 weeks and asked to use the electronic cigarette as a substitute for smoking combustible cigarettes during the 4 weeks |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Study Feasibility | Participant enrollment, measured by the proportion of eligible participants who enroll in the study. Retention is measured by weeks of study participation. | The number of participants analyzed is different than the sample size as the outcome is participant enrollment among those eligible. | Posted | Count of Participants | Participants | 4 weeks |
|
Adverse event data were collected for 8 weeks
Adverse event collection occurred at the end of every study visit using a form where participants were asked about serious adverse events since the previous visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NJOY ACE E-cigarette Provision | Device: NJOY ACE e-cigarette, 5% nicotine in tobacco flavor Patients will be provided with a NJOY ACE electronic cigarette for 4 weeks and asked to use the NJOY ACE as a substitute for smoking combustible cigarettes during the 4 weeks. NJOY ACE e-cigarette: Patients will be provided with NJOY ACE electronic cigarettes and 5% nicotine e-liquid cartridges in tobacco flavor for 4 weeks and asked to use the electronic cigarette as a substitute for smoking combustible cigarettes during the 4 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coughing | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nancy Rigotti, Study PI | Massachusetts General Hospital | 6177243548 | nrigotti@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 10, 2024 | Nov 30, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 18, 2024 | Nov 30, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000072137 | Vaping |
| D000073865 | Cigarette Smoking |
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D001519 | Behavior |
| D000073869 | Tobacco Smoking |
| D064424 | Tobacco Use |
| D019966 |
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Open-label single-arm pilot clinical trial
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Self-reported number of cigarettes smoked per day in the past week between end of e-cigarette provision and end of study (week 4 to week 8) |
| 4 weeks (Weeks 4-8) |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Cigarettes Smoked Per Day | Mean | Standard Deviation | cigarettes/day |
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|
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| Primary | Cigarettes Per Day (CPD) Smoked During the Period of E-cigarette Provision | Change in self-reported CPD smoked in the past week assessed using timeline follow-back (TLFB) between baseline and end of e-cigarette provision (Baseline vs.Week 4) | Posted | Mean | Standard Deviation | cigarettes/day | 4 weeks |
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| Secondary | Carbon Monoxide (CO) Concentration in Expired Air | Change in participant's expired air carbon monoxide (CO) concentration assessed via Smokerlyzer during the period of e-cigarette provision (Baseline vs.week 4) | Posted | Mean | Standard Deviation | ppm | 4 weeks |
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| Secondary | Cigarettes Smoked Per Day After E-cigarette Provision Ends | Self-reported number of cigarettes smoked per day in the past week between end of e-cigarette provision and end of study (week 4 to week 8) | Posted | Mean | Standard Deviation | cigarettes/day | 4 weeks (Weeks 4-8) |
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| 0 |
| 15 |
| 0 |
| 15 |
| 3 |
| 15 |
| Dizziness or headache | General disorders | Non-systematic Assessment |
|
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| Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |