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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA204891-01 | U.S. NIH Grant/Contract | View source | |
| NCI-2019-01855 | Registry Identifier | CTRP (Clinical Trial Reporting Program |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Cancer Institute (NCI) | NIH |
| University of Minnesota | OTHER |
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The overall aim of the proposed study is to evaluate the effect of switching from conventional cigarettes to either a LWe or HWe on smoking behavior, product use patterns and continued use, as well as biomarkers of toxicant exposure and effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low wattage E cigarette device | Active Comparator |
| |
| High wattage E cigarette device | Active Comparator |
| |
| Usual brand cigarette | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low wattage E cigarette device | Behavioral | The low wattage E cigarette device will be provided to the participant and they will be instructed to vape ad libitum for 12 weeks and then be assessed at 6 months and 12 months for continued use of device. |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Change From Conventional Cigarettes - Self Report | Self-Reported 7-day Point Prevalence Abstinence from Cigarettes evaluated via the Timeline Follow Back Questionnaire. An intent-to-treat approach is taken where no participants are excluded and missing data is imputed as not abstinent from cigarettes. | Week 4, Week 8, Week 12, Week 26, and Week 52 |
| Complete Change From Conventional Cigarettes - Biochemically Verified | Intent to treat biochemically verified abstinence rates - participants reporting both 7-day point prevalence abstinence and an exhaled carbon monoxide reading less than or equal to 10. An intent-to-treat approach is taken where no participants are excluded and missing data is imputed as not abstinent from cigarettes. | Week 4, Week 8, Week 12, Week 26, and Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Cigarette Dependence | Cigarette Dependence Scale Scores range from 12 to 60 with higher scores indicating greater dependence. | Baseline, Week 1, Week 4, Week 8, Week 12, Week 26 and Week 52 |
| Cigarette Likeability/Preference |
Not provided
Inclusion Criteria:
Exclusion Criteria:
<18 years old;
unstable or significant medical condition such as respiratory, kidney, or liver disease that could potentially affect biomarker data;
unstable or significant psychiatric conditions (past and stable conditions will be allowed);
history of cardiac event or distress within the past 3 months; and
currently pregnant, planning to become pregnant, or breastfeeding (n.b: pregnancy status will continue to be evaluated throughout the study at each visit).
-
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| Name | Affiliation | Role |
|---|---|---|
| Theodore Wagener, PhD | Ohio State Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43214 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42167788 | Derived | Cho YJ, Hinton A, Nshimiyimana J, Mehta T, Queimado L, Stepanov I, Case S, Beebe LA, Wagener TL. The effect of higher versus lower wattage e-cigarettes on smoking: A randomized controlled trial. Addiction. 2026 May 21. doi: 10.1111/add.70421. Online ahead of print. |
| Label | URL |
|---|---|
| The Jamesline | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Brand Cigarette | Usual brand cigarette: The usual brand of cigarettes will be provided to the participant and they will be instructed to smoke ad libitum for the duration of the study. |
| FG001 | Low Wattage E Cigarette Device | Low wattage E cigarette device: The low wattage E cigarette device will be provided to the participant and they will be instructed to vape ad libitum for 12 weeks and then be assessed at 6 months and 12 months for continued use of device. |
| FG002 | High Wattage E Cigarette Device | High wattage E cigarette device: The high wattage E cigarette device will be provided to the participant and they will be instructed to vape ad libitum for 12 weeks and then be assessed at 6 months and 12 months for continued use of device. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Brand Cigarette | Usual brand cigarette: The usual brand of cigarettes will be provided to the participant and they will be instructed to smoke ad libitum for the duration of the study. |
| BG001 | Low Wattage E Cigarette Device |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Complete Change From Conventional Cigarettes - Self Report | Self-Reported 7-day Point Prevalence Abstinence from Cigarettes evaluated via the Timeline Follow Back Questionnaire. An intent-to-treat approach is taken where no participants are excluded and missing data is imputed as not abstinent from cigarettes. | Posted | Count of Participants | Participants | Week 4, Week 8, Week 12, Week 26, and Week 52 |
|
1 year
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Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Brand Cigarette | Usual brand cigarette: The usual brand of cigarettes will be provided to the participant and they will be instructed to smoke ad libitum for the duration of the study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stroke | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergies | Immune system disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Theodore L. Wagener | OhioSUCCC | 614-366-4265 | Theodore.Wagener@osumc.edu |
Not provided
| 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 | Mar 20, 2023 | Nov 6, 2023 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000073865 | Cigarette Smoking |
| D000073869 | Tobacco Smoking |
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
| D019966 | Substance-Related Disorders |
Not provided
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| High wattage E cigarette device | Behavioral | The high wattage E cigarette device will be provided to the participant and they will be instructed to vape ad libitum for 12 weeks and then be assessed at 6 months and 12 months for continued use of device. |
|
| Usual brand cigarette | Behavioral | The usual brand of cigarettes will be provided to the participant and they will be instructed to smoke ad libitum for the duration of the study. |
|
Cigarette Evaluation Scale Scores range from 1 to 7 with higher scores indicating greater satisfaction, psychological reward, aversion, or relief
| Baseline, Week 4, Week 12, Week 26, and Week 52 |
| EC Likeability/Preference | EC modified-Cigarette Evaluation Scale Scores range from 1 to 7 with higher scores indicating greater satisfaction, psychological reward, aversion, or relief. No results are reported for the Usual Brand Cigarette arm as the participants in this arm did not receive a study e-cigarette device and thus were not asked to respond to the e-cigarette modified cigarette evaluation scale items. | Week 4, Week 12 |
| EC Abuse Liability | An adapted version of the Drug Effects/Liking Questionnaire will assess the desire and liking of all three study products. Five visual analog scale items ranging from 0 ('not at all') to 100 ('extremely') assessed wanting to smoke the product again, liking the product, enjoying the product, finding the product pleasurable and satisfying. | Week 4, Week 12, Week 26, and Week 52 |
| Biomarker of Exposure - NNAL | Urinary total 4-(methylnitrosamine)-1-(3-pyridyl)-1-butanol [NNAL] (pmol/mg creatinine) | Baseline, Week 4, Week 12 |
| Biomarker of Exposure - NNN | Presence of urinary [pyridine-D4]NNN ([D4]NNN) (pmol/mg creatinine) | Baseline, Week 4, Week 12 |
| Biomarker of Exposure - Total Nicotine Equivalents (TNE) | Sum of nicotine and metabolites in urine - Total Nicotine Equivalents (TNE) (nmol/mg creatinine) | Baseline, Week 4, Week 12 |
| Biomarker of Exposure - Nickel | Metals and metalloids in saliva - Nickel (ng/mL) | Baseline, Week 4, Week 12 |
| Biomarker of Exposure - Cadmium | Metals and metalloids in saliva - Cadmium (ng/mL) | Baseline, Week 4, Week 12 |
| Biomarker of Exposure - Lead | Metals and metalloids in saliva - Lead (ng/mL) | Baseline, Week 4, Week 12 |
| Biomarker of Exposure - 8-iso-PGF2a | Urinary biomarker of oxidative stress and inflammation - 8-iso-PGF2a (pmol/mg creatinine) | Baseline, Week 4, Week 12 |
| Biomarker of Effect - q-PADDA | Data is shown as change in DNA damage from baseline. We calculated change in DNA damage in Transcribed (TS) and Non-transcribed strand (NTS) and added those data points to calculate the Total Change in DNA damage. Results are presented as change in number of DNA lesions per 10,000 base pairs. | Week 4, Week 12 |
| Biomarker of Exposure - Nicotine Metabolite Ratio | Biomarker of nicotine clearance formed using the ratio of 2 nicotine metabolites (3'hydroxycotinine [3HC]/cotinine) | Baseline, Week 4, Week 12 |
| Biomarker of Exposure - PGEM | Urinary biomarker of oxidative stress and inflammation | Baseline, Week 4, Week 12 |
| Ineligible |
|
| Study Team Decision |
|
Low wattage E cigarette device: The low wattage E cigarette device will be provided to the participant and they will be instructed to vape ad libitum for 12 weeks and then be assessed at 6 months and 12 months for continued use of device.
| BG002 | High Wattage E Cigarette Device | High wattage E cigarette device: The high wattage E cigarette device will be provided to the participant and they will be instructed to vape ad libitum for 12 weeks and then be assessed at 6 months and 12 months for continued use of device. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Cigarettes Smoked per Day | 3 participants were missing data on the number of cigarettes smoked per day at baseline. | Mean | Standard Deviation | cigarettes per day |
|
| OG002 | High Wattage E Cigarette Device | High wattage E cigarette device: The high wattage E cigarette device will be provided to the participant and they will be instructed to vape ad libitum for 12 weeks and then be assessed at 6 months and 12 months for continued use of device. |
|
|
| Primary | Complete Change From Conventional Cigarettes - Biochemically Verified | Intent to treat biochemically verified abstinence rates - participants reporting both 7-day point prevalence abstinence and an exhaled carbon monoxide reading less than or equal to 10. An intent-to-treat approach is taken where no participants are excluded and missing data is imputed as not abstinent from cigarettes. | Posted | Count of Participants | Participants | Week 4, Week 8, Week 12, Week 26, and Week 52 |
|
|
|
| Secondary | Cigarette Dependence | Cigarette Dependence Scale Scores range from 12 to 60 with higher scores indicating greater dependence. | Participants who attended the study visit and responded to the items in the cigarette dependence scale. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 1, Week 4, Week 8, Week 12, Week 26 and Week 52 |
|
|
|
| Secondary | Cigarette Likeability/Preference | Cigarette Evaluation Scale Scores range from 1 to 7 with higher scores indicating greater satisfaction, psychological reward, aversion, or relief | Participants who attended the study visit and answered the Cigarette Evaluation Scale items | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 4, Week 12, Week 26, and Week 52 |
|
|
|
| Secondary | EC Likeability/Preference | EC modified-Cigarette Evaluation Scale Scores range from 1 to 7 with higher scores indicating greater satisfaction, psychological reward, aversion, or relief. No results are reported for the Usual Brand Cigarette arm as the participants in this arm did not receive a study e-cigarette device and thus were not asked to respond to the e-cigarette modified cigarette evaluation scale items. | Participants who attended the study visit and answered the EC modified Cigarette Evaluation Scale items | Posted | Mean | Standard Deviation | score on a scale | Week 4, Week 12 |
|
|
|
| Secondary | EC Abuse Liability | An adapted version of the Drug Effects/Liking Questionnaire will assess the desire and liking of all three study products. Five visual analog scale items ranging from 0 ('not at all') to 100 ('extremely') assessed wanting to smoke the product again, liking the product, enjoying the product, finding the product pleasurable and satisfying. | For weeks 26 and 52, only participants who reported continued use of the study product were asked the items on the questionnaire. | Posted | Mean | Standard Deviation | score on a scale | Week 4, Week 12, Week 26, and Week 52 |
|
|
|
| Secondary | Biomarker of Exposure - NNAL | Urinary total 4-(methylnitrosamine)-1-(3-pyridyl)-1-butanol [NNAL] (pmol/mg creatinine) | Participants who provided a urine sample which was able to be analyzed | Posted | Mean | Standard Deviation | pmol/mg creatinine | Baseline, Week 4, Week 12 |
|
|
|
| Secondary | Biomarker of Exposure - NNN | Presence of urinary [pyridine-D4]NNN ([D4]NNN) (pmol/mg creatinine) | Participants who provided a urine sample which was able to be analyzed | Posted | Mean | Standard Deviation | pmol/mg creatinine | Baseline, Week 4, Week 12 |
|
|
|
| Secondary | Biomarker of Exposure - Total Nicotine Equivalents (TNE) | Sum of nicotine and metabolites in urine - Total Nicotine Equivalents (TNE) (nmol/mg creatinine) | Participants who provided a urine sample which was able to be analyzed | Posted | Mean | Standard Deviation | nmol/mg creatinine | Baseline, Week 4, Week 12 |
|
|
|
| Secondary | Biomarker of Exposure - Nickel | Metals and metalloids in saliva - Nickel (ng/mL) | Participants who provided a saliva sample which was able to be analyzed | Posted | Mean | Standard Deviation | ng/mL | Baseline, Week 4, Week 12 |
|
|
|
| Secondary | Biomarker of Exposure - Cadmium | Metals and metalloids in saliva - Cadmium (ng/mL) | Participants who provided a saliva sample which was able to be analyzed | Posted | Mean | Standard Deviation | ng/mL | Baseline, Week 4, Week 12 |
|
|
|
| Secondary | Biomarker of Exposure - Lead | Metals and metalloids in saliva - Lead (ng/mL) | Participants who provided a saliva sample which was able to be analyzed | Posted | Mean | Standard Deviation | ng/mL | Baseline, Week 4, Week 12 |
|
|
|
| Secondary | Biomarker of Exposure - 8-iso-PGF2a | Urinary biomarker of oxidative stress and inflammation - 8-iso-PGF2a (pmol/mg creatinine) | Participants who provided a urine sample which was able to be analyzed | Posted | Mean | Standard Deviation | pmol/mg creatinine | Baseline, Week 4, Week 12 |
|
|
|
| Secondary | Biomarker of Effect - q-PADDA | Data is shown as change in DNA damage from baseline. We calculated change in DNA damage in Transcribed (TS) and Non-transcribed strand (NTS) and added those data points to calculate the Total Change in DNA damage. Results are presented as change in number of DNA lesions per 10,000 base pairs. | Participants who provided oral mucosa samples which were able to be analyzed | Posted | Mean | Standard Deviation | Number of DNA lesions/10,000 base pairs | Week 4, Week 12 |
|
|
|
| Secondary | Biomarker of Exposure - Nicotine Metabolite Ratio | Biomarker of nicotine clearance formed using the ratio of 2 nicotine metabolites (3'hydroxycotinine [3HC]/cotinine) | Although participant samples were collected, they were not analyzed to determine the nicotine metabolite ratio due to budget reductions for this study. There are no plans to analyze NMR in these samples in the future. | Posted | Baseline, Week 4, Week 12 |
|
|
|
| Secondary | Biomarker of Exposure - PGEM | Urinary biomarker of oxidative stress and inflammation | Although participant urine samples were collected, they were not analyzed to determine the PGEM due to budget reductions for this study. There are no plans to analyze the PGEM in these samples in the future. | Posted | Baseline, Week 4, Week 12 |
|
|
|
| 0 |
| 105 |
| 3 |
| 105 |
| 64 |
| 105 |
| EG001 | Low Wattage E Cigarette Device | Low wattage E cigarette device: The low wattage E cigarette device will be provided to the participant and they will be instructed to vape ad libitum for 12 weeks and then be assessed at 6 months and 12 months for continued use of device. | 0 | 133 | 2 | 133 | 103 | 133 |
| EG002 | High Wattage E Cigarette Device | High wattage E cigarette device: The high wattage E cigarette device will be provided to the participant and they will be instructed to vape ad libitum for 12 weeks and then be assessed at 6 months and 12 months for continued use of device. | 0 | 134 | 2 | 134 | 95 | 134 |
| High Blood Pressure | Cardiac disorders | Systematic Assessment |
|
| Blood Clot | Cardiac disorders | Systematic Assessment |
|
| Possible Skin Cancer | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Heart Attack | Cardiac disorders | Systematic Assessment |
|
| Heartburn | Gastrointestinal disorders | Systematic Assessment |
|
| Knee Surgery | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Seizure | Nervous system disorders | Systematic Assessment |
|
| Loss of feeling in mouth and jaw | Nervous system disorders | Systematic Assessment |
|
| Sharp Chest Pains | Cardiac disorders | Systematic Assessment |
|
| Breathing Difficulties | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Chest Pain | General disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Sore or Dry Mouth and Throat | Gastrointestinal disorders | Systematic Assessment |
|
| Gingivitis | Gastrointestinal disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Mouth or Tongue Sores / Inflammation | Gastrointestinal disorders | Systematic Assessment |
|
| Sleepiness | Nervous system disorders | Systematic Assessment |
|
| Sleeplessness | Psychiatric disorders | Systematic Assessment |
|
Not provided
Not provided
| D064419 |
| Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Title | Measurements |
|---|---|
|
| Week 12 |
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| Week 26 |
|
| Week 52 |
|
| Week 1 |
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| Week 4 |
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| Week 8 |
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| Week 12 |
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| Week 26 |
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| Week 52 |
|
|
| Psychological Reward - Baseline |
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| Aversion - Baseline |
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| Relief - Baseline |
|
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| Satisfaction - Week 4 |
|
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| Psychological Reward - Week 4 |
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| Aversion - Week 4 |
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| Relief - Week 4 |
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| Satisfaction - Week 12 |
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| Psychological Reward - Week 12 |
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| Aversion - Week 12 |
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| Relief - Week 12 |
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| Satisfaction - Week 26 |
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| Psychological Reward - Week 26 |
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| Aversion - Week 26 |
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| Relief - Week 26 |
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| Satisfaction - Week 52 |
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| Psychological Reward - Week 52 |
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| Aversion - Week 52 |
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| Relief - Week 52 |
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| Psychological Reward - Week 4 |
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| Aversion - Week 4 |
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| Relief - Week 4 |
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| Satisfaction - Week 12 |
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| Psychological Reward - Week 12 |
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| Aversion - Week 12 |
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| Relief - Week 12 |
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| Like - Week 4 |
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| Enjoy - Week 4 |
|
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| Pleasurable - Week 4 |
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| Satisfying - Week 4 |
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| Want - Week 12 |
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| Like - Week 12 |
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| Enjoy - Week 12 |
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| Pleasurable - Week 12 |
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| Satisfying - Week 12 |
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| Want - Week 26 |
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| Like - Week 26 |
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| Enjoy - Week 26 |
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| Pleasurable - Week 26 |
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| Satisfying - Week 26 |
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| Want - Week 52 |
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| Like - Week 52 |
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| Enjoy - Week 52 |
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| Pleasurable - Week 52 |
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| Satisfying - Week 52 |
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| Week 12 |
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| Week 12 |
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| Week 12 |
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| Week 12 |
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| Week 12 |
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| Week 12 |
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| Week 4 |
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| Week 12 |
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| Week 12 |
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