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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05855343
Other study ID # BIDI
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 14, 2023
Est. completion date December 5, 2023

Study information

Verified date March 2024
Source Rose Research Center, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date December 5, 2023
Est. primary completion date September 5, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 22 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Rose Research Center Charlotte North Carolina
United States Rose Research Center Raleigh North Carolina

Sponsors (2)

Lead Sponsor Collaborator
Rose Research Center, LLC Foundation for a Smoke Free World INC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Number of participants that completely switch from combustible cigarettes to e-cigarette Self-report of no smoking Daily during Week 9 - Week 12
Other 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
Other Number of participants that completely switch from combustible cigarettes to e-cigarette Expired air carbon monoxide (CO) value of <5 ppm Week 12
Other Number of participants that completely switch from combustible cigarettes to e-cigarette Self-report of no smoking Week 12
Primary Degree of Smoking Reduction Change in expired air carbon monoxide (CO) at the end of the product use period After 12 Weeks
Primary Degree of Smoking Reduction Change in self-reported cigarettes smoked daily From Baseline to Week 12
Secondary 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
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