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| Name | Class |
|---|---|
| Foundation for a Smoke Free World INC | OTHER |
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The aim of this study is to shed light on the importance of nicotine pharmacokinetics in switching to a reduced-harm product by fully matching the nicotine pharmacokinetics of smokers' usual brands of cigarettes.
The primary objective is to ascertain the degree of smoking reduction when smokers attempt to switch to an e-cigarette that matches peak nicotine concentrations of a cigarette.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIDI Stick e-cigarette | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIDI Stick e-cigarette | Other | The BIDI will be dispensed, and subjects will be instructed to use the BIDI as often as they like during the 12 week period, and to switch completely to the BIDI within 1 week. If, however, they do smoke any CC, they will also be instructed to use the BIDI immediately before each CC to relieve their craving as much as possible before smoking their usual brand. The BIDI will also be the first product that they are instructed to use each morning. Smokers will be told to try to completely substitute BIDI for CCs by the end of the first week of use. |
| Measure | Description | Time Frame |
|---|---|---|
| Degree of Smoking Reduction | Change in expired air carbon monoxide (CO) at the end of the product use period | After 12 Weeks |
| Degree of Smoking Reduction | Change in self-reported cigarettes smoked daily | From Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective response to an e-cigarette | To assess subjective satisfaction and other perceived rewarding or aversive effects accompanying e-cigarette use and combustible cigarette use using the modified (e-Cigarette) Cigarette Evaluation Questionnaire. This questionnaire contains five subscale scores: smoking satisfaction (satisfying, tastes good, enjoy smoking), psychological rewards (calms down, more awake, less irritable, helps concentrate, reduces hunger), aversion (dizziness, nauseated), enjoyment of respiratory tract sensations (single-item assessment), craving reduction (single-item assessment). Participants will be asked to assess the 12 items of the questionnaire on a 7-point scale, ranging from "not at all" to "extremely". |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants that completely switch from combustible cigarettes to e-cigarette | Self-report of no smoking | Daily during Week 9 - Week 12 |
| Number of participants that completely switch from combustible cigarettes to e-cigarette |
Inclusion Criteria:
Exclusion Criteria:
Is unhealthy or cannot participate in the study for any reason (e.g., medical, psychiatric, and/or social reason) as judged by the Investigator or designated medical staff based on all available assessments from the screening period (e.g., vital signs, physical examination, ECG, concomitant medications and medical history).
PHQ-9 score greater than 9, or a score greater than 0 on item #9 ("Thoughts that you would be better off dead, or of hurting yourself in some way") at screening.
Planned use of an FDA-approved smoking cessation product during the study.
High Blood Pressure (systolic >150 mm Hg, diastolic >95 mm Hg) at screening.
Body mass index (BMI) less than 15.0 kg/m2 or greater than 40.0 kg/m2 at screening.
Coronary heart disease, structural cardiac disease (including, but not limited to valvular heart disease or cardiac murmurs), cardiac dysrhythmias, syncope, cardiac chest pain, or history of heart attack or heart failure.
Has received psychotherapy or behavioral treatments within 30 days of screening, or during the study.
Taking antidepressants or psychoactive medications (e.g. antipsychotics, benzodiazepines, hypnotics).
Use of any of these products in the past 30 days:
Use of smokeless tobacco (chewing tobacco, snuff), cigars (except for "Black & Mild" cigars or Cigarillos), pipes, hookah, e-cigarettes, nicotine replacement therapy or other smoking cessation treatments within 14 days of screening.
Pregnant or nursing (by self-report) or positive pregnancy test.
Enrollment is complete.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rose Research Center | Charlotte | North Carolina | 28262 | United States | ||
| Rose Research Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39075535 | Derived | Rose JE, Behm FM, Cohen G, Willette PN, Botts TL, Botts DR. Smoking reduction using an electronic nicotine delivery system (ENDS) with nicotine delivery similar to combustible cigarettes. Harm Reduct J. 2024 Jul 29;21(1):142. doi: 10.1186/s12954-024-01064-0. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 21, 2025 | |
| Reset | Feb 12, 2025 | |
| Release | Mar 17, 2025 | |
| Reset | Apr 3, 2025 | |
| Release | Feb 4, 2026 | |
| Reset | Feb 23, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 21, 2025 | Feb 12, 2025 | |||
| Mar 17, 2025 |
| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D012907 | Smoking |
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|
| From Baseline to Week 12 |
Expired air carbon monoxide (CO) value of <5 ppm
| Week 9 - Week 12 |
| Number of participants that completely switch from combustible cigarettes to e-cigarette | Expired air carbon monoxide (CO) value of <5 ppm | Week 12 |
| Number of participants that completely switch from combustible cigarettes to e-cigarette | Self-report of no smoking | Week 12 |
| Raleigh |
| North Carolina |
| 27617 |
| United States |
| Apr 3, 2025 |
| Feb 4, 2026 | Feb 23, 2026 |