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

NCT05855343 | Completed

• 1 other identifier: BIDI
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

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.

Conditions

Smoking Cessation

Keywords

e-cigarette

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Subjective response to an e-cigarette

  From Baseline to Week 12

Other Outcomes (4)

• Number of participants that completely switch from combustible cigarettes to e-cigarette

  Daily during Week 9 - Week 12

• Number of participants that completely switch from combustible cigarettes to e-cigarette

  Week 9 - Week 12

• Number of participants that completely switch from combustible cigarettes to e-cigarette

  Week 12

Study Arms (1)

BIDI Stick e-cigarette

EXPERIMENTAL

Other: BIDI Stick e-cigarette

Interventions

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.

BIDI Stick e-cigarette

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rose Research Center, LLC: lead
• Foundation for a Smoke Free World INC: collaborator

Study Sites (2)

Rose Research Center

Charlotte, North Carolina, 28262, United States

Location

Rose Research Center

Raleigh, North Carolina, 27617, United States

Location

Related Publications (1)

• 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.

  PMID: 39075535 DERIVED

MeSH Terms

Conditions

Smoking Cessation; Vaping

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Smoking

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2023
• First Posted: May 11, 2023
• Study Start: February 14, 2023
• Primary Completion: September 5, 2023
• Study Completion: December 5, 2023
• Last Updated: March 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)