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| ID | Type | Description | Link |
|---|---|---|---|
| 5P50DA036105-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| Penn State University | OTHER |
| Food and Drug Administration (FDA) | FED |
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The purpose of this study is to use Randomized Controlled Trial (RCT) methods to examine the influence of novel tobacco products on biomarkers of toxicant exposure and disease risk, reports of adverse events, and concurrent use of other tobacco products. In this case, the novel products are one type of electronic cigarette and an imitation cigarette or cigarette substitute.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cigarette substitute | Experimental | The QuitSmart cigarette substitute is a plastic tube that looks like a real cigarette and is designed to provide the same draw resistance as a smoker's usual cigarette. There is no drug delivery with this product. Two cigarette substitutes and a product manual are provided to participants following randomization and replacement products are provided throughout the intervention period (24 weeks). |
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| e-cigarette (with 0 mg/ml nicotine) | Experimental | The e-cigarette used will be the EGO e-cigarette (marketed by www.liquidexpress.com). Each participant randomized to an ECIG condition will receive 2 e-cigarette batteries, 1 wall adapter, 1 USB charger, and a user manual. Cartomizers containing 0 mg/ml nicotine will be provided throughout the intervention period (24 weeks). |
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| e-cigarette (with 8 mg/ml nicotine) | Experimental | The e-cigarette used will be the EGO e-cigarette (marketed by www.liquidexpress.com). Each participant randomized to an ECIG condition will receive 2 e-cigarette batteries, 1 wall adapter, 1 USB charger, and a user manual. Cartomizers containing 8 mg/ml nicotine will be provided throughout the intervention period (24 weeks). |
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| e-cigarette (with 36 mg/ml nicotine) | Experimental | The e-cigarette used will be the EGO e-cigarette (marketed by www.liquidexpress.com). Each participant randomized to an ECIG condition will receive 2 e-cigarette batteries, 1 wall adapter, 1 USB charger, and a user manual. Cartomizers containing 36 mg/ml nicotine will be provided throughout the intervention period (24 weeks). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| e-cigarette | Other |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| urine carcinogen biomarker of exposure, NNAL | changes in NNAL concentration measured at week 0, week 4, week 12, and week 24 | week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| urine biomarker of nicotine exposure, cotinine | changes in cotinine concentration measured at week 0, week 4, week 12, and week 24 | week 24 |
| blood, urine, and exhaled breath condensate biomarkers of oxidative stress, glutathione and 8 Isoprostanes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Eissenberg | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States | ||
| Center for the Study of Tobacco Products |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40533223 | Derived | Dahal S, Yingst J, Wang X, Cobb CO, Carrillo M, Hrabovsky S, Bascom R, Lopez AA, Kang L, Maloney S, Halquist M, Foulds J, Veldheer S. Changes in cardiovascular disease risk, lung function and other clinical health outcomes when people who smoke use e-cigarettes to reduce cigarette smoking: an exploratory analysis from a randomised placebo-controlled trial. BMJ Open. 2025 Jun 18;15(6):e098005. doi: 10.1136/bmjopen-2024-098005. | |
| 39142511 | Derived |
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| ID | Term |
|---|---|
| D066300 | Electronic Nicotine Delivery Systems |
| ID | Term |
|---|---|
| D000074602 | Smoking Devices |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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| cigarette substitute |
| Other |
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changes in oxidative stress biomarker concentrations measured at week 0, week 4, week 12, and week 24
| week 24 |
| Richmond |
| Virginia |
| 23298 |
| United States |
| Cobb CO, Budd S, Maldonado G, Imran R, Foulds J, Yingst J, Yen MS, Kang L, Sun S, Hall PB, Chowdhury N, Cohen JE; Randomized Control Trial Methods Workgroup of the Center for the Study of Tobacco Products: Member List. Predictors of attrition in a randomized controlled trial of an electronic nicotine delivery system among people interested in cigarette smoking reduction. Contemp Clin Trials. 2024 Oct;145:107662. doi: 10.1016/j.cct.2024.107662. Epub 2024 Aug 12. |
| 33857436 | Derived | Cobb CO, Foulds J, Yen MS, Veldheer S, Lopez AA, Yingst JM, Bullen C, Kang L, Eissenberg T; Randomised Control Trial Methods Workgroup of the Center for the Study of Tobacco Products. Effect of an electronic nicotine delivery system with 0, 8, or 36 mg/mL liquid nicotine versus a cigarette substitute on tobacco-related toxicant exposure: a four-arm, parallel-group, randomised, controlled trial. Lancet Respir Med. 2021 Aug;9(8):840-850. doi: 10.1016/S2213-2600(21)00022-9. Epub 2021 Apr 12. |
| 26941050 | Derived | Lopez AA, Cobb CO, Yingst JM, Veldheer S, Hrabovsky S, Yen MS, Foulds J, Eissenberg T. A transdisciplinary model to inform randomized clinical trial methods for electronic cigarette evaluation. BMC Public Health. 2016 Mar 3;16:217. doi: 10.1186/s12889-016-2792-8. |