CSD210903: A Study to Determine Subject Puffing Patterns of a Heated Tobacco Product With Four Non-Combusted Cigarette Variants in an Ambulatory Setting

NCT05307822 | Completed

• 1 other identifier: CSD210903
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 7

Brief Summary

This is a multi-center, open-label, parallel-cohort-study to evaluate the puffing patterns of healthy adult consumers of tobacco products switching from a usual brand (UB) combustible cigarette (CC) and/or a UB Heated Tobacco Product (HTP) to one of four investigational products (IPs), across two heating modes, over a 28-day ambulatory period.

Conditions

Smoking; Smoking Behaviors; Tobacco Use; Tobacco Smoking

Outcome Measures

Primary Outcomes (1)

• Arithmetic Mean

  Arithmetic Mean puff duration across the final 14 days of data collection

  14 days

Study Arms (2)

Cohort 1: Menthol with HTP device (20020064)

EXPERIMENTAL

Subjects will self-assign to one of three menthol flavor variants of non-combusted cigarette products based on their self-reported flavor usage history.

Other: Non-combusted cigarette variant 42001401; Other: Non-combusted cigarette variant 42001399; Other: Non-combusted cigarette variant 40007386

Cohort 2: Non-Menthol with HTP device (20020064)

EXPERIMENTAL

Subjects will self-assign to a non-menthol flavor variant of a non-combusted cigarette product based on their self-reported flavor usage history.

Other: Non-combusted cigarette variant 42001402

Interventions

Non-combusted cigarette variant 42001401 OTHER

Menthol flavor variant of a non-combusted cigarette (42001401)

Cohort 1: Menthol with HTP device (20020064)

Non-combusted cigarette variant 42001399 OTHER

Menthol flavor variant of a non-combusted cigarette (42001399)

Cohort 1: Menthol with HTP device (20020064)

Non-combusted cigarette variant 40007386 OTHER

Menthol flavor variant of a non-combusted cigarette (40007386)

Cohort 1: Menthol with HTP device (20020064)

Non-combusted cigarette variant 42001402 OTHER

Non-Menthol flavor variant of a non-combusted cigarette (42001402)

Cohort 2: Non-Menthol with HTP device (20020064)

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.
• CC or HTP is 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 CC or HTP is their primary product.
• Must have used 5 or more CCs or HTP sticks per day 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). Dual users of CCs and HTPs (either 5 CCs or 5 sticks per day or a combination of 5 products per day) will also be allowed into the study.
• Males must use an acceptable method of birth control from Visit 1 until the end of the study, unless they have had a vasectomy or are abstinent from heterosexual intercourse (as a lifestyle choice, not just for the purpose of study participation), or their female partner is not able to bear children.
• Females must be willing to use a form of contraception acceptable to the PI from the time of signing informed consent until the end of the study.
• Examples of acceptable means of birth control are, but not limited to:
• Surgical sterilization (hysterectomy, bilateral tubal ligation/occlusion, bilateral oophorectomy, bilateral salpingectomy);
• Established use of oral, implantable, injectable or transdermal methods of contraception associated with inhibition of ovulation;
• Physical barrier method (e.g., condom, diaphragm/sponge/cervical cap) with spermicide;
• Non-hormone releasing intrauterine devices (IUD) or hormone-releasing IUDs (e.g., Mirena or Kyleena);
• Vasectomized partner;
• Abstinence from heterosexual intercourse (as a lifestyle choice, not just for the purpose of study participation); and
• Post-menopausal and not on hormone replacement therapy.

You may not qualify if:

• Presence of clinically significant uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, gastrointestinal, psychiatric, hematological, or neurological disease, or any other concurrent disease or medical condition that, in the opinion of the PI, makes the study participant unsuitable to participate in this clinical study.
• History of, presence of, or clinical laboratory test results indicating diabetes.
• Systolic blood pressure of \> 160 mmHg or a diastolic blood pressure of \> 95 mmHg, measured after being seated for five minutes.
• 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 allowed at the PI's discretion, pending written approval from the Medical Monitor.
• Any history of cancer, except for primary cancers of skin such as localized basal cell/squamous cell carcinoma that have been surgically and/or cryogenically removed.
• Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
• Use of any medication or substance that aids in smoking cessation, including but not limited to: NRT (e.g., nicotine gum, lozenge, patch), varenicline (Chantix®), bupropion (Wellbutrin®, Zyban®), or lobelia extract within (≤) 30 days prior to signing the ICF.
• Participation in another clinical trial within (≤) 30 days prior to signing the ICF. 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, breastfeeding, or intend to become pregnant during the course of the study.
• Subjects ≥ 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 Visit or Enrollment Visit.
• 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 alcohol test result at the Screening Visit or Enrollment Visit.
• 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 (7)

Wake Research (MTVCR)

Sandy Springs, Georgia, 30328, United States

Location

AMR Lexington

Lexington, Kentucky, 40509, United States

Location

Rose Research Center

Charlotte, North Carolina, 28262, United States

Location

High Point Clinical Trials Center

High Point, North Carolina, 27265, United States

Location

Rose Research Center

Raleigh, North Carolina, 27617, United States

Location

Benchmark Research

Fort Worth, Texas, 76135, United States

Location

Benchmark Research

San Angelo, Texas, 76904, United States

Location

MeSH Terms

Conditions

Smoking; Tobacco Use; Tobacco Smoking

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: March 23, 2022
• First Posted: April 1, 2022
• Study Start: April 21, 2022
• Primary Completion: November 11, 2022
• Study Completion: November 11, 2022
• Last Updated: March 27, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)