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

Not Applicable

Completed

• Conditions: Smoking Cessation
• Interventions: Other: BIDI Stick e-cigarette

• Registration Number: NCT05855343
• Lead Sponsor: Rose Research Center, LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-25
• Study Start: 2023-02-14
• Study First Submitted QC: 2023-05-02
• Study First Posted: 2023-05-11
• Primary Completion: 2023-09-05
• Study Completion: 2023-12-05
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-18
• Last Update Posted: 2024-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BIDI Stick e-cigarette	BIDI Stick e-cigarette	-

Primary Outcome Measures

Name	Time	Method
Degree of Smoking Reduction	From Baseline to Week 12	Change in self-reported cigarettes smoked daily

Secondary Outcome Measures

Name	Time	Method
Subjective response to an e-cigarette	From Baseline to Week 12	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".

Trial Locations

Locations (1)

Rose Research Center; 🇺🇸 Raleigh, North Carolina, United States