CSD201203: A Study to Determine Subject Puffing Patterns of a Non-cylindrical, Closed, Electronic Nicotine Delivery System at Three Nicotine Concentrations in an Ambulatory Setting

NCT05118139 | Completed

• 1 other identifier: CSD201203
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 4

Brief Summary

This is a multi-center, open-label, parallel, three-study-group investigation to evaluate the puffing patterns of healthy adult consumers of tobacco products switching from a usual brand (UB) Electronic Nicotine Delivery Systems (ENDS) product to the ENDS Investigational Product (IP), over a 9-day ambulatory period.

Conditions

Smoking; Tobacco Use; Electronic Cigarette Use

Outcome Measures

Primary Outcomes (2)

• Puff duration

  Average puff duration

  Final 7 days of data collection

• Number of puff per day

  Average number of puffs per day

  Final 7 days of data collection

Study Arms (3)

1.5% nicotine cartridges

EXPERIMENTAL

Subjects will self-assign to one of 7 flavor variants of 1.5% ENDS products based on their preferred flavor.

Other: P1211216; Other: P1213416; Other: P1213716; Other: P1213616; Other: P1213816; Other: P1211916; Other: P1210016

2.4% nicotine cartridges

EXPERIMENTAL

Subjects will self-assign to one of 2 flavor variants of 2.4% ENDS products based on their preferred flavor.

Other: P1211217; Other: P1213417

5% nicotine cartridges

EXPERIMENTAL

Subjects will self-assign to one of 7 flavor variants of 5% ENDS products based on their preferred flavor.

Other: P1211222; Other: P1213422; Other: P1213722; Other: P1213622; Other: P1213822; Other: P1211922; Other: P1210022

Interventions

P1211216 OTHER

Flavor variant P1211216 of a 1.5% nicotine ENDS product

1.5% nicotine cartridges

P1213416 OTHER

Flavor variant P1213416 of a 1.5% nicotine ENDS product

1.5% nicotine cartridges

P1213716 OTHER

Flavor variant P1213716 of a 1.5% nicotine ENDS product

1.5% nicotine cartridges

P1213616 OTHER

Flavor variant P1213616 of a 1.5% nicotine ENDS product

1.5% nicotine cartridges

P1213816 OTHER

Flavor variant P1213816 of a 1.5% nicotine ENDS product

1.5% nicotine cartridges

P1211916 OTHER

Flavor variant P1211916 of a 1.5% nicotine ENDS product

1.5% nicotine cartridges

P1210016 OTHER

Flavor variant P1210016 of a 1.5% nicotine ENDS product

1.5% nicotine cartridges

P1211217 OTHER

Flavor variant P1211217 of a 2.4% nicotine ENDS product

2.4% nicotine cartridges

P1213417 OTHER

Flavor variant P1213417 of a 2.4% nicotine ENDS product

2.4% nicotine cartridges

P1211222 OTHER

Flavor variant P1211222 of a 5% nicotine ENDS product

5% nicotine cartridges

P1213422 OTHER

Flavor variant P1213422 of a 5% nicotine ENDS product

5% nicotine cartridges

P1213722 OTHER

Flavor variant P1213722 of a 5% nicotine ENDS product

5% nicotine cartridges

P1213622 OTHER

Flavor variant P1213622 of a 5% nicotine ENDS product

5% nicotine cartridges

P1213822 OTHER

Flavor variant P1213822 of a 5% nicotine ENDS product

5% nicotine cartridges

P1211922 OTHER

Flavor variant P1211922 of a 5% nicotine ENDS product

5% nicotine cartridges

P1210022 OTHER

Flavor variant P1210022 of a 5% nicotine ENDS product

5% nicotine cartridges

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to read, understand, and willing to sign an informed consent form (ICF) and complete questionnaires written in English.
• Generally healthy male or female adults, ≥ 21 years of age, inclusive, at the time of consent.
• Positive urine cotinine test at the Screening Visit.
• Non-cylindrical, cartridge-based, closed-system ENDS are the primary form of tobacco- or nicotine-containing products used within 30 days of the Screening Visit. Subjects may be users of other tobacco- or nicotine-containing products. If the subject is a dual/poly user of tobacco- or /nicotine-containing products then the subject must self-report that a non-cylindrical, cartridge-based, closed-system ENDS is their primary product.
• Must have used 2 or more cartridges per week over the last 30 days. Brief periods of abstinence due to illness, quit attempt (prior to 30 days of the Screening Visit), or clinical study participation (prior to 30 days of the Screening Visit) will be allowed at the discretion of the Principal Investigator (PI).
• Females must be willing to use a form of contraception acceptable to the PI from the time of signing the ICF until the end of the study.
• Must be willing to use the assigned IP and only the assigned flavor as their exclusive source of ENDS use for the full duration of the 9-day ambulatory period. Use of other non-ENDS tobacco- or nicotine-containing products will be permitted during the ambulatory period.
• Must have familiarity with modern electronic devices such as an IOS/Android smart phone or tablet computer ("tablet") and be willing to be provided with an electronic device, that allows for both Bluetooth connectivity and internet connectivity. Must be willing to use an application on the electronic device and keep the application active for the length of the study
• Able to safely perform the required study procedures, as determined by the PI.

You may not qualify if:

• Presence of clinically significant uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, gastrointestinal, psychiatric, hematological, neurological disease, or any other concurrent disease or medical condition that, in the opinion of the PI, makes the study subject unsuitable to participate in this clinical study.
• History of or presence of diabetes.
• Systolic blood pressure of \> 160 mmHg or a diastolic blood pressure of \> 95 mmHg, measured after being seated for five minutes, with exceptions at the PI's discretion.
• Scheduled treatment for asthma currently or within the past consecutive 12 months prior to the Screening Visit. As-needed treatment, such as inhalers, may be included at the PI's discretion pending approval from the Medical Monitor.
• Any history of cancer, except for primary cancers of skin such as localized basal cell/squamous cell carcinoma that has been surgically and/or cryogenically removed.
• Use of any medication or substance that aids in smoking cessation, including but not limited to any nicotine replacement therapy (NRT, e.g., nicotine gum, lozenge, patch), varenicline (Chantix®), bupropion (Wellbutrin®, Zyban®), or lobelia extract within (≤) 30 days prior to the signing the ICF.
• Participation in another clinical trial within (≤) 30 days prior to signing the ICF unless allowed at the discretion of the Principal Investigator (PI). The 30-day window for each subject will be derived from the date of the last study event in the previous study to the time of signing the ICF in the current study.
• Females who have a positive pregnancy test, or who are pregnant, are breastfeeding, or intend to become pregnant during the course of the study.
• Individuals ≥ 35 years of age currently using systemic, estrogen-containing contraception or hormone replacement therapy.
• A positive urine drug screen without evidence of prescribed corresponding concomitant medication(s) at the Screening or Enrollment Visits.
• Postpones a decision to quit using tobacco- or nicotine-containing products in order to participate in this study or a previous attempt within (≤) 30 days prior to signing the ICF.
• Drinks more than 21 servings of alcoholic beverages per week or has a positive test for alcohol result at the Screening or Enrollment Visits.
• Employed by a tobacco- or nicotine-manufacturing company, the study site, or handles tobacco- or nicotine-containing products as part of their job.
• Determined by the PI to be inappropriate for this study.

Sponsors & Collaborators

• RAI Services Company: lead

Study Sites (4)

Clinical Research Atlanta

Stockbridge, Georgia, 30281, United States

Location

AMR Lexington

Lexington, Kentucky, 40509, United States

Location

Accellacare Hickory

Hickory, North Carolina, 28601, United States

Location

High Point Clinical Trials Center

High Point, North Carolina, 27265, United States

Location

MeSH Terms

Conditions

Smoking; Tobacco Use; Vaping

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Gary Dull, PhD

  RAIS

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2021
• First Posted: November 11, 2021
• Study Start: February 11, 2022
• Primary Completion: July 30, 2022
• Study Completion: July 30, 2022
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)