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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21DA037407-01 | 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 purpose of this study is to examine cigarette smokers' use of electronic cigarettes (e-cigarettes), and how use of e-cigarettes affects short term smoking behavior.
Study initiation will commence after the first telephone contact (phone pre-screen), at the baseline visit. Additional lab visits will occur at days 8, 15, and 22 (visits 2-4). At the first study visit, 2/3rds of the participants will be randomly assigned to sample e-cigarettes and 1/3rd will not. Participants in the e-cigarette group will be provided with sufficient product to sample and use as they wish, but with minimal instruction on purpose and level of use (non-use is an outcome). Smokers in the control group will smoke their own brand of cigarettes, as they wish, for the duration of the sampling period. All participants will engage in ecological momentary assessments, which will be completed 3 times daily for 3 weeks. In-person follow-up assessments will be conducted at 1, 2, and 3 months after the final lab visit (Day 22).
Overall, each participant will be contacted 8 times: at the phone pre-screening, the 4 lab visits, and 3 follow-up visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cigarette group | Active Comparator | This group (1/3 of the sample) will not receive electronic cigarettes to sample and will continue smoking their regular cigarettes as much or as little as they would like. |
|
| electronic cigarette | Experimental | This group (2/3 of the sample) will be given electronic cigarettes for a 3-week period, to use as much or as little as they would like. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| electronic cigarette | Other |
|
| |
| cigarette group |
| Measure | Description | Time Frame |
|---|---|---|
| Uptake of Electronic Nicotine Delivery Systems (ENDS) | % of participants by group used e-cigarettes in week 16 | study week 16 |
| Independent Purchase of an ENDs Product | % of participants by group who purchased an ENDs product on their own during the study | study enrollment to study week 16 |
| % Quit Attempts | % of participants who made any quit attempt during study | study enrollment to study week 16 |
| Point Prevalence Abstinence | % of participants with CO-verified cigarette abstinence at study week 16 | week 16 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew J Carpenter, PhD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 16 mg Electronic Nicotine Delivery Systems (ENDS) | Study Participants were randomized in a 2:1 ratio to receive electronic nicotine delivery systems (ENDS) or not. Changes in product design, i.e., improved nicotine delivery (16mg vs. 24mg), midway through the study allowed the unexpected but compelling opportunity to examine two ENDS products compared to control group. |
| FG001 | 24 mg Electronic Nicotine Delivery Systems (ENDS) | Study Participants were randomized in a 2:1 ratio to receive electronic nicotine delivery systems (ENDS) or not. Changes in product design, i.e., improved nicotine delivery (16mg vs. 24mg), midway through the study allowed the unexpected but compelling opportunity to examine two ENDS products compared to control group. |
| FG002 | Control Group | This group (1/3 of the sample) did not receive electronic cigarettes to sample and continued smoking their regular cigarettes as much or as little as they chose. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 16 mg Electronic Nicotine Delivery Systems (ENDS) | Study Participants were randomized in a 2:1 ratio to receive electronic nicotine delivery systems (ENDS) or not. Changes in product design, i.e., improved nicotine delivery (16mg vs. 24mg), midway through the study allowed the unexpected but compelling opportunity to examine two ENDS products compared to control group. |
| 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 | Uptake of Electronic Nicotine Delivery Systems (ENDS) | % of participants by group used e-cigarettes in week 16 | Posted | Number | percentage of participants | study week 16 |
|
study week 2 to study week 16
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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 | 24 mg Electronic Nicotine Delivery Systems (ENDS) | Study Participants were randomized in a 2:1 ratio to receive electronic nicotine delivery systems (ENDS) or not. Changes in product design, i.e., improved nicotine delivery (16mg vs. 24mg), midway through the study allowed the unexpected but compelling opportunity to examine two ENDS products compared to control group. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Matthew Carpenter | Medical University of South Carolina | 843-876-2436 | carpente@musc.edu |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| D014029 | Tobacco Use Disorder |
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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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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| Other |
|
| BG001 | 24 mg Electronic Nicotine Delivery Systems (ENDS) | Study Participants were randomized in a 2:1 ratio to receive electronic nicotine delivery systems (ENDS) or not. Changes in product design, i.e., improved nicotine delivery (16mg vs. 24mg), midway through the study allowed the unexpected but compelling opportunity to examine two ENDS products compared to control group. |
| BG002 | Control Group | This group (1/3 of the sample) did not receive electronic cigarettes to sample and continued smoking their regular cigarettes as much or as little as they chose. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Control Group | This group (1/3 of the sample) did not receive electronic cigarettes to sample and continued smoking their regular cigarettes as much or as little as they chose. |
|
|
| Primary | Independent Purchase of an ENDs Product | % of participants by group who purchased an ENDs product on their own during the study | Posted | Number | percentage of participants | study enrollment to study week 16 |
|
|
|
| Primary | % Quit Attempts | % of participants who made any quit attempt during study | Posted | Number | percentage of participants | study enrollment to study week 16 |
|
|
|
| Primary | Point Prevalence Abstinence | % of participants with CO-verified cigarette abstinence at study week 16 | Posted | Number | percentage of participants | week 16 |
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 11 |
| 21 |
| EG001 | 16 mg Electronic Nicotine Delivery Systems (ENDS) | Study Participants were randomized in a 2:1 ratio to receive electronic nicotine delivery systems (ENDS) or not. Changes in product design, i.e., improved nicotine delivery (16mg vs. 24mg), midway through the study allowed the unexpected but compelling opportunity to examine two ENDS products compared to control group. | 0 | 25 | 0 | 25 | 9 | 25 |
| EG002 | Control Group | This group (1/3 of the sample) did not receive electronic cigarettes to sample and continued smoking their regular cigarettes as much or as little as they chose. | 0 | 22 | 0 | 22 | 8 | 22 |
| nausea | Gastrointestinal disorders | Systematic Assessment |
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| headache | Nervous system disorders | Systematic Assessment |
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| Mouth/throat irritation | Gastrointestinal disorders | Systematic Assessment |
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| Trouble sleeping | General disorders | Systematic Assessment |
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| heartburn | Gastrointestinal disorders | Systematic Assessment |
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| dizziness or lightheadness | Nervous system disorders | Systematic Assessment |
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| other | General disorders | Systematic Assessment |
|
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