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| ID | Type | Description | Link |
|---|---|---|---|
| U01DA045517 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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The overall goal of this project is to understand the likely health effects of cigarette smokers switching to a Standardized Research Electronic Cigarette (SREC) and to assess the role of nicotine delivery on switching and acceptability as well as markers of health outcomes.
Current smokers who meet all eligibility criteria will completely switch from their combustible (regular) cigarettes to an electronic cigarette (SREC) that either contains 58 mg/ml of nicotine or 0 mg/ml of nicotine in the liquid.
The investigators' hypothesis is that attempting to switch to a SREC will result in a reduction in markers of harms to health, as compared with the baseline (smoking) measures. The investigators also hypothesize that nicotine-containing SRECs will facilitate switching from smoking more efficiently than zero nicotine SRECs and will result in a significantly greater improvement in markers of health risk, but will result in higher ratings of dependence on the SREC (as compared to the zero nicotine SREC).
This project is a prospective parallel-group randomized double-blind, placebo-controlled study in which 104 current smokers who are willing to completely switch from their regular cigarettes to an electronic cigarette (SREC) for 6 weeks will be randomly allocated to use a SREC containing either 58 or 0 mg/ml nicotine in the liquid.
Following randomization to their assigned study product, participants will be supported in their switching efforts with regular contacts both in person at the Penn State Milton S. Hershey Medical Center and over the phone. The main measures will be recorded at two in-person visits after the randomization (switching) visit: (a) 3 weeks after switching and (b) 6 weeks after switching. All participants will also be followed up at 10 weeks by phone to identify whether they have continued to use electronic cigarettes or regular cigarettes and to assess their motivation to change.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nicotine-Containing Electronic Cigarette | Experimental | The experimental group will be provided with and encouraged to use a Standardized Research Electronic Cigarette (SREC) with liquid containing 58 mg/ml nicotine for the duration of 6 weeks. |
|
| Non-Nicotine Electronic Cigarette | Placebo Comparator | The placebo group will be provided with and encouraged to use a Standardized Research Electronic Cigarette (SREC) with liquid containing 0 mg/ml nicotine for the duration of 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine-Containing Electronic Cigarette | Other | The electronic cigarette (e-cig) used in this study will be the Standardized Research Electronic Cigarette (SREC). The SREC product is a pod-based device and comprises a replaceable pre-filled liquid reservoir ("pod") and a rechargeable power supply unit. The experimental group in this project will receive a SREC device with liquid containing 58 mg/mL of nicotine. |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary NNAL Concentration | Concentration of urinary carcinogen biomarker of exposure, NNAL, corrected for creatinine | 6-week visit (post-treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Pulmonary Function | Forced expiratory volume in one second (FEV1). | 6-week visit (post-treatment) |
| Exhaled Carbon Monoxide (CO) | Exhaled CO (parts per million [ppm]) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Foulds, PhD | The Pennsylvania State University College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Pennsylvania State University College of Medicine | Hershey | Pennsylvania | 17033 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42154468 | Derived | Yingst JM, Krebs NM, Dahal S, Allen SI, Livelsberger C, Peters V, Salkin A, Bordner C, Mazhar L, Reinhart L, Trushin N, Zimmerman C, Hassan K, Bitzer Z, Sciamanna C, Zhu J, Foulds J. Toxicant Exposures After Switching From Cigarettes to a Pod-Based Electronic Cigarette: A Randomized Clinical Trial. JAMA Netw Open. 2026 May 1;9(5):e2613292. doi: 10.1001/jamanetworkopen.2026.13292. |
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One participant was excluded from the study before their assignment to a group because she did not meet the eligibility criteria for blood pressure.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nicotine-Containing Electronic Cigarette | The experimental group will be provided with and encouraged to use a Standardized Research Electronic Cigarette (SREC) with liquid containing 58 mg/ml nicotine for the duration of 6 weeks. Nicotine-Containing Electronic Cigarette: The electronic cigarette (e-cig) used in this study will be the Standardized Research Electronic Cigarette (SREC). The SREC product is a pod-based device and comprises a replaceable pre-filled liquid reservoir ("pod") and a rechargeable power supply unit. The experimental group in this project will receive a SREC device with liquid containing 58 mg/mL of nicotine. |
| FG001 | Non-Nicotine Electronic Cigarette | The placebo group will be provided with and encouraged to use a Standardized Research Electronic Cigarette (SREC) with liquid containing 0 mg/ml nicotine for the duration of 6 weeks. Non-Nicotine Electronic Cigarette: The electronic cigarette (e-cig) used in this study will be the Standardized Research Electronic Cigarette (SREC). The SREC product is a pod-based device and comprises a replaceable pre-filled liquid reservoir ("pod") and a rechargeable power supply unit. The placebo group in this project will receive a SREC device with liquid containing 0 mg/mL of nicotine. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Randomization Period |
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| 10 Week Post-treatment |
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| ID | Title | Description |
|---|---|---|
| BG000 | Nicotine-Containing Electronic Cigarette | The experimental group will be provided with and encouraged to use a Standardized Research Electronic Cigarette (SREC) with liquid containing 58 mg/ml nicotine for the duration of 6 weeks. Nicotine-Containing Electronic Cigarette: The electronic cigarette (e-cig) used in this study will be the Standardized Research Electronic Cigarette (SREC). The SREC product is a pod-based device and comprises a replaceable pre-filled liquid reservoir ("pod") and a rechargeable power supply unit. The experimental group in this project will receive a SREC device with liquid containing 58 mg/mL of nicotine. |
| 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 | Urinary NNAL Concentration | Concentration of urinary carcinogen biomarker of exposure, NNAL, corrected for creatinine | Four missing values because sample could not be analyzed | Posted | Mean | Standard Deviation | ng/ml | 6-week visit (post-treatment) |
|
10 weeks
Adverse events (AEs) were systematically collected at each study visit by asking participants about any changes in their medication, their physical or mental health, or if they needed to seek immediate medical care at an emergency room or hospital.
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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 | Nicotine-Containing Electronic Cigarette | The experimental group will be provided with and encouraged to use a Standardized Research Electronic Cigarette (SREC) with liquid containing 58 mg/ml nicotine for the duration of 6 weeks. Nicotine-Containing Electronic Cigarette: The electronic cigarette (e-cig) used in this study will be the Standardized Research Electronic Cigarette (SREC). The SREC product is a pod-based device and comprises a replaceable pre-filled liquid reservoir ("pod") and a rechargeable power supply unit. The experimental group in this project will receive a SREC device with liquid containing 58 mg/mL of nicotine. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stroke | Cardiac disorders | CTCAE v5.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety | Psychiatric disorders | CTCAE v5.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jonathan Foulds | Penn State College of Medicine | (717) 531-3504 | jfoulds@pennstatehealth.psu.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 11, 2024 | Jan 23, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D012907 | Smoking |
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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| Non-Nicotine Electronic Cigarette | Other | The electronic cigarette (e-cig) used in this study will be the Standardized Research Electronic Cigarette (SREC). The SREC product is a pod-based device and comprises a replaceable pre-filled liquid reservoir ("pod") and a rechargeable power supply unit. The placebo group in this project will receive a SREC device with liquid containing 0 mg/mL of nicotine. |
|
|
| 6-week visit (post-treatment) |
| Urine Cotinine Concentration | Cotinine (ng/ml) will serve as a measure of exposure to nicotine. | 6-week visit (post-treatment) |
| Blood Pressure | systolic blood pressure in mm Hg | 6-week visit (post-treatment) |
| Fagerstrom Test for Nicotine Dependence Mean Total Score | Nicotine dependence for cigarettes will be assessed via the Fagerstrom Test for Nicotine Dependence (FTND), a measure with total scores ranging from 0 (very low dependence) to 10 (very high dependence). | 6-week visit (post-treatment) |
| Penn State Electronic Cigarette Dependence Index | Nicotine dependence for e-cigarettes will be assessed via the Penn State Electronic Nicotine Dependence Index, a measure with total scores ranging from 0 (very low dependence) to 20 (very high dependence). | 6-week visit (post-treatment) |
| Cigarettes Per Day | Mean number of cigarettes smoked per day based on the past 7 days | 6-week visit (post-treatment) |
| Number of Participants With Abstinence From Cigarettes and Other Tobacco (Not Including E-cigs) | Zero cigarettes or other tobacco products (not including e-cigs) used in the past 7 days and a CO <6ppm | 6-week visit (post-treatment) |
| Total Score on Minnesota Nicotine Withdrawal Scale | Withdrawal and craving will be assessed via the Minnesota Nicotine Withdrawal Scale. Total scores range from 0-28. Higher scores indicate worse withdrawal symptoms. | 1-week visit (post-treatment) |
| Cigarettes Per Day | Mean number of cigarettes smoked per day based on the past 7 days | 10-week visit (post-treatment) |
| E-cig Use Days | The number of days the e-cig was used since 6-week visit (post-treatment) | 10-week visit (post-treatment) |
| Number of Participants With Self-reported Abstinence | Abstinence will be considered zero cigarettes and other tobacco products (not including e-cigs) in the past 7 days | 10-week visit (post-treatment) |
| Heart Rate Variability (HRV) | Heart Rate Variability (HRV) will be assessed from resting Holter EKG output. | 6-week visit (post-treatment) |
| Presence of Premature Ventricular Contractions (PVCs) | Presence of PVCs will be assessed from resting Holter EKG output. | 6-week visit (post-treatment) |
| ST-Elevation | ST-Elevation will be assessed from resting Holter EKG output | 6-week visit (post-treatment) |
| QRS Duration | QRS duration will be assessed from resting Holter EKG output. | 6-week visit (post-treatment) |
| NOT COMPLETED |
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| BG001 | Non-Nicotine Electronic Cigarette | The placebo group will be provided with and encouraged to use a Standardized Research Electronic Cigarette (SREC) with liquid containing 0 mg/ml nicotine for the duration of 6 weeks. Non-Nicotine Electronic Cigarette: The electronic cigarette (e-cig) used in this study will be the Standardized Research Electronic Cigarette (SREC). The SREC product is a pod-based device and comprises a replaceable pre-filled liquid reservoir ("pod") and a rechargeable power supply unit. The placebo group in this project will receive a SREC device with liquid containing 0 mg/mL of nicotine. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Education | Count of Participants | Participants |
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| OG001 | Non-Nicotine Electronic Cigarette | The placebo group will be provided with and encouraged to use a Standardized Research Electronic Cigarette (SREC) with liquid containing 0 mg/ml nicotine for the duration of 6 weeks. Non-Nicotine Electronic Cigarette: The electronic cigarette (e-cig) used in this study will be the Standardized Research Electronic Cigarette (SREC). The SREC product is a pod-based device and comprises a replaceable pre-filled liquid reservoir ("pod") and a rechargeable power supply unit. The placebo group in this project will receive a SREC device with liquid containing 0 mg/mL of nicotine. |
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| Secondary | Pulmonary Function | Forced expiratory volume in one second (FEV1). | Posted | Mean | Standard Deviation | liters | 6-week visit (post-treatment) |
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| Secondary | Exhaled Carbon Monoxide (CO) | Exhaled CO (parts per million [ppm]) | Posted | Mean | Standard Deviation | ppm | 6-week visit (post-treatment) |
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| Secondary | Urine Cotinine Concentration | Cotinine (ng/ml) will serve as a measure of exposure to nicotine. | Three missing values because sample could not be analyzed | Posted | Mean | Standard Deviation | ng/ml | 6-week visit (post-treatment) |
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| Secondary | Blood Pressure | systolic blood pressure in mm Hg | Posted | Mean | Standard Deviation | mmHg | 6-week visit (post-treatment) |
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| Secondary | Fagerstrom Test for Nicotine Dependence Mean Total Score | Nicotine dependence for cigarettes will be assessed via the Fagerstrom Test for Nicotine Dependence (FTND), a measure with total scores ranging from 0 (very low dependence) to 10 (very high dependence). | Questionnaire was only given to participants who used cigarettes in the past 7 days | Posted | Mean | Standard Deviation | score on a scale | 6-week visit (post-treatment) |
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| Secondary | Penn State Electronic Cigarette Dependence Index | Nicotine dependence for e-cigarettes will be assessed via the Penn State Electronic Nicotine Dependence Index, a measure with total scores ranging from 0 (very low dependence) to 20 (very high dependence). | Questionnaire was only given to participants who used the e-cigarette in the past 7 days | Posted | Mean | Standard Deviation | score on a scale | 6-week visit (post-treatment) |
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| Secondary | Cigarettes Per Day | Mean number of cigarettes smoked per day based on the past 7 days | Missing data for cigarettes per day for two participants | Posted | Mean | Standard Deviation | cigarettes per day | 6-week visit (post-treatment) |
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| Secondary | Number of Participants With Abstinence From Cigarettes and Other Tobacco (Not Including E-cigs) | Zero cigarettes or other tobacco products (not including e-cigs) used in the past 7 days and a CO <6ppm | This is an intent-to-treat analysis so everyone who was randomized was included in the sample analyzed | Posted | Count of Participants | Participants | 6-week visit (post-treatment) |
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| Secondary | Total Score on Minnesota Nicotine Withdrawal Scale | Withdrawal and craving will be assessed via the Minnesota Nicotine Withdrawal Scale. Total scores range from 0-28. Higher scores indicate worse withdrawal symptoms. | Posted | Mean | Standard Deviation | score on a scale | 1-week visit (post-treatment) |
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| Secondary | Cigarettes Per Day | Mean number of cigarettes smoked per day based on the past 7 days | Posted | Mean | Standard Deviation | cigarettes per day | 10-week visit (post-treatment) |
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| Secondary | E-cig Use Days | The number of days the e-cig was used since 6-week visit (post-treatment) | Data missing from participant six participants | Posted | Mean | Standard Deviation | days | 10-week visit (post-treatment) |
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| Secondary | Number of Participants With Self-reported Abstinence | Abstinence will be considered zero cigarettes and other tobacco products (not including e-cigs) in the past 7 days | Posted | Count of Participants | Participants | 10-week visit (post-treatment) |
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| Secondary | Heart Rate Variability (HRV) | Heart Rate Variability (HRV) will be assessed from resting Holter EKG output. | Five participants had missing data due to EKG not functioning and/or low quality data | Posted | Mean | Standard Deviation | msec | 6-week visit (post-treatment) |
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| Secondary | Presence of Premature Ventricular Contractions (PVCs) | Presence of PVCs will be assessed from resting Holter EKG output. | Five participants had missing data due to EKG not functioning and/or low quality data | Posted | Mean | Standard Deviation | count of PVCs | 6-week visit (post-treatment) |
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| Secondary | ST-Elevation | ST-Elevation will be assessed from resting Holter EKG output | Six participants had missing data due to EKG not functioning and/or low quality data | Posted | Mean | Standard Deviation | µV | 6-week visit (post-treatment) |
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| Secondary | QRS Duration | QRS duration will be assessed from resting Holter EKG output. | Six participants had missing data due to EKG not functioning and/or low quality data | Posted | Mean | Standard Deviation | msec | 6-week visit (post-treatment) |
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|
|
| 0 |
| 52 |
| 1 |
| 52 |
| 11 |
| 52 |
| EG001 | Non-Nicotine Electronic Cigarette | The placebo group will be provided with and encouraged to use a Standardized Research Electronic Cigarette (SREC) with liquid containing 0 mg/ml nicotine for the duration of 6 weeks. Non-Nicotine Electronic Cigarette: The electronic cigarette (e-cig) used in this study will be the Standardized Research Electronic Cigarette (SREC). The SREC product is a pod-based device and comprises a replaceable pre-filled liquid reservoir ("pod") and a rechargeable power supply unit. The placebo group in this project will receive a SREC device with liquid containing 0 mg/mL of nicotine. | 0 | 52 | 0 | 52 | 8 | 52 |
| COVID-19 | Infections and infestations | CTCAE v5.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | CTCAE v5.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE v5.0 | Systematic Assessment |
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| Headache | Nervous system disorders | CTCAE v5.0 | Systematic Assessment |
|
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