NCT05855343CompletedNot Applicable
Exploratory Study of Switching From Combustible Cigarettes to the BIDI E-cigarette
Rose Research Center, LLC3 sites in 1 country25 target enrollmentStarted: February 14, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Rose Research Center, LLC
- Enrollment
- 25
- Locations
- 3
- Primary Endpoint
- Degree of Smoking Reduction
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 22 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Degree of Smoking Reduction
Time Frame: From Baseline to Week 12
Change in self-reported cigarettes smoked daily
Secondary Outcomes
- Subjective response to an e-cigarette(From Baseline to Week 12)
Investigators
Study Sites (3)
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