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

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 Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Other: BIDI Stick e-cigarette

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28262
      • Rose Research Center
    • Raleigh, North Carolina, United States, 27617
      • Rose Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Has signed the ICF and is able to understand the information provided in the ICF.
2. Is 22 to 65 years of age (inclusive) at screening.
3. Smokes ≥ 10 commercially available CCs per day (no brand restrictions), for the last 12 months.
4. Expired air CO reading of at least 10 ppm as assessed at the screening session.
5. Interested in switching to an electronic cigarette.
6. Willing and able to comply with the requirements of the study.
7. Owns a smart phone with text message and data capabilities compatible with necessary surveys.

Exclusion Criteria:

1. 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).
2. 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.
3. Planned use of an FDA-approved smoking cessation product during the study.
4. High Blood Pressure (systolic >150 mm Hg, diastolic >95 mm Hg) at screening.
5. Body mass index (BMI) less than 15.0 kg/m2 or greater than 40.0 kg/m2 at screening.
6. 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.
7. Has received psychotherapy or behavioral treatments within 30 days of screening, or during the study.
8. Taking antidepressants or psychoactive medications (e.g. antipsychotics, benzodiazepines, hypnotics).

9. Use of any of these products in the past 30 days:

   1. Illegal drugs (or if the urine drug screen is positive for cocaine, THC, amphetamines, phencyclidine (PCP), or opiates without a medical prescription);
   2. Experimental (investigational) drugs that are unknown to participant;
   3. Chronic opiate use.
10. 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.
11. Pregnant or nursing (by self-report) or positive pregnancy test.
12. Enrollment is complete.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: BIDI Stick e-cigarette

Other: BIDI Stick e-cigarette; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Rose Research Center, LLC
• Collaborators: Foundation for a Smoke Free World INC

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2023
• Primary Completion (Actual): September 5, 2023
• Study Completion (Actual): December 5, 2023

Study Registration Dates

• First Submitted: January 25, 2023
• First Submitted That Met QC Criteria: May 2, 2023
• First Posted (Actual): May 11, 2023

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: e-cigarette
• Other Study ID Numbers: BIDI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No