Exploratory Study of Switching From Combustible Cigarettes to the BIDI E-cigarette

Study Overview
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Brief Summary
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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.

Official Title
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Exploratory Study of Switching From Combustible Cigarettes to the BIDI E-cigarette

Conditions
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Smoking Cessation

Intervention / Treatment
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* Other: BIDI Stick e-cigarette


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has signed the ICF and is able to understand the information provided in the ICF. Is 22 to 65 years of age (inclusive) at screening. Smokes ≥ 10 commercially available CCs per day (no brand restrictions), for the last 12 months. Expired air CO reading of at least 10 ppm as assessed at the screening session. Interested in switching to an electronic cigarette. Willing and able to comply with the requirements of the study. Owns a smart phone with text message and data capabilities compatible with necessary surveys. 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: Illegal drugs (or if the urine drug screen is positive for cocaine, THC, amphetamines, phencyclidine (PCP), or opiates without a medical prescription); Experimental (investigational) drugs that are unknown to participant; Chronic opiate use. 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.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BIDI Stick e-cigarette<br> | Other: BIDI Stick e-cigarette<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | From Baseline to Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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e-cigarette