A RCT to Determine the Effect of ENDS Flavor Availability on Abstinence Within Smokers

NCT07172438 | Terminated

• 1 other identifier: PHCB3US20256
• Study Type: interventional
• Target: 668
• Locations: 1 country
• Sites: 27

Brief Summary

The overall purpose of this study will be to assess primary combustible cigarette users' abstinence from smoking their usual brand of combustible cigarettes at the end of the study, when provided with an electronic nicotine delivery system (ENDS) power unit (2) and varying levels of access to tobacco-flavored, menthol-flavored, or non-tobacco/non-menthol-flavored cartridge-based e-liquids (collectively referred to as the investigational product) within their assigned study arm over a three-month (ninety-day) period.

Conditions

Smoking; Tobacco

Keywords

Tobacco Harm Reduction; Smoking; Tobacco Use; Tobacco Smoking

Outcome Measures

Primary Outcomes (1)

• Past 7-day abstinence from combustible cigarette smoking for the final 7 days of the 13-week study period

  The odds (i.e., relative probabilities) of participants self-reporting 7-day point prevalence abstinence from combustible cigarette (CC) smoking, as recorded in an electronic diary (eDiary) during the final 7 days of the 13-week study period, comparing Study Arm 1 versus Study Arm 3, and Study Arm 2 versus Study Arm 3.

  13-weeks

Secondary Outcomes (6)

• Odds of final 7-day abstinence between each of the preferred flavor groups (Study Arms 1 and 2).

  13-weeks

• Odds rate of final 7-day complete switching between each of the preferred flavor groups (Study Arms 1 and 2 only).

  13-weeks

• Time to first 7-day abstinence by Study Arm.

  13-weeks

• Time to first 7-day abstinence by preferred flavor group.

  13-weeks

• Weekly mean percent cigarettes per day reductions from baseline by Study Arm and preferred flavor group.

  13-weeks

Study Arms (3)

Tobacco, Menthol, Non Tobacco Non Menthol Flavors

ACTIVE COMPARATOR

Participants can choose between tobacco, menthol, and non-tobacco non-menthol flavor variants at one nicotine level (5%).

Other: P2611222; Other: P2615022; Other: P2615122; Other: P2613422

Tobacco and Menthol Flavor

ACTIVE COMPARATOR

Participants can choose between tobacco and menthol flavor variants at one nicotine level (5%).

Other: P2611222; Other: P2613422

Tobacco Flavor

ACTIVE COMPARATOR

Participants can use a tobacco flavor variant at one nicotine level (5%).

Other: P2613422

Interventions

P2615022 OTHER

Non-tobacco non-menthol flavor

Tobacco, Menthol, Non Tobacco Non Menthol Flavors

P2615122 OTHER

Non-tobacco non-menthol flavor

Tobacco, Menthol, Non Tobacco Non Menthol Flavors

P2613422 OTHER

Tobacco flavor

Tobacco Flavor; Tobacco and Menthol Flavor; Tobacco, Menthol, Non Tobacco Non Menthol Flavors

P2611222 OTHER

Menthol flavor

Tobacco and Menthol Flavor; Tobacco, Menthol, Non Tobacco Non Menthol Flavors

Eligibility Criteria

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

You may qualify if:

• Able to read, understand, and are willing to sign an Informed Consent Form (ICF) and complete questionnaires written in English
• Generally healthy male or female, between 21 and 65 years of age, inclusive, at the time of consent
• All female (assigned at birth) candidate participants who agree during the pre-screener to receive and take a home pregnancy test prior to the SEV, and who affirm at the SEV that they are not pregnant or intending to become pregnant.
• NOTE: Participants who identify as "intersex" or "unknown" during screening, will be offered the opportunity to receive a pregnancy test if they wish to take one.
• Currently smoke at least 10 cigarettes on smoking days in the past 30 days
• Smoke cigarettes regularly for at least 12 months
• Smoke cigarettes on 15 or more of the past 30 days
• Smoked at least 100 cigarettes in their lifetime prior to the screening and enrollment visit.
• Must indicate smoking factory-made filtered menthol and/or non-menthol cigarettes as their primary nicotine product (Occasional use of other tobacco- or nicotine-containing products is acceptable)
• Indicate a willingness to use ENDS
• Agree to participate in the study and to abide by the study restrictions and requirements, as described in the informed concent form (ICF)

You may not qualify if:

• Female participants who are pregnant or breastfeeding or planning to become pregnant or start breastfeeding within the next 6 months based on self-report.
• Female participants who self-report not using adequate methods to prevent pregnancy
• Persons with pacemakers or other embedded electronic medical devices fitted
• Persons who self-report heart disease, high blood pressure, diabetes, cancer, Chronic Obstructive Pulmonary Disease, emphysema, asthma or other lung/breathing conditions, a previous history of heart attack or stroke, or are taking medication for depression.
• Persons who self-report they are allergic/sensitive to cosmetics or fragrances or to any ingredient listed in Vuse commercial products or similar products, including those listed below:
• Carvone (L-)
• Benzyl alcohol
• Participants who have used ENDS, nicotine pouch or smokeless tobacco (i.e., chewing tobacco, snus, or snuff) products on 5 or more days in the past 30 days
• Participants who have used ENDS, nicotine pouch or smokeless tobacco products more than 100 times in their lifetime
• Participants who have used a nicotine replacement therapy (NRT) product or a prescription drug to help stop smoking (e.g., varenicline, bupropion) in the past 30 days.
• Employee of a company that manufactures tobacco or ENDS products
• Persons who are personally, have household members, or have close family or friends in litigation with a company that manufactures tobacco or ENDS products
• Have taken part in a tobacco/nicotine research study in the past 30 days

Sponsors & Collaborators

• RAI Services Company: lead

Study Sites (27)

CRG Test America-Phoenix

Chandler, Arizona, 85226, United States

Location

C&C-Fort Smith

Fort Smith, Arkansas, 72908, United States

Location

Research America Orlando

Altamonte Springs, Florida, 32701, United States

Location

C&C-Tampa

Clearwater, Florida, 33761, United States

Location

Sago Orlando

Maitland, Florida, 32751, United States

Location

CRG Test America-Pembroke Pines

Miami, Florida, 33026, United States

Location

CRG Test America-Ormond Beach

Ormond Beach, Florida, 32174, United States

Location

C&C-Plantation

Plantation, Florida, 33388, United States

Location

C&C-Sebring

Sebring, Florida, 33870, United States

Location

C&C-Tallahassee

Tallahassee, Florida, 32301, United States

Location

CRG Test America-Tampa

Tampa, Florida, 33609, United States

Location

C&C-Lombard

Lombard, Illinois, 60148, United States

Location

C&C-Troy

Troy, Michigan, 48083, United States

Location

CRG Test America-St. Peters

City of Saint Peters, Missouri, 63376, United States

Location

C&C-Richmond Heights

St Louis, Missouri, 63117, United States

Location

Sago St. Louis

St Louis, Missouri, 63131, United States

Location

Sago Philadelphia

Philadelphia, Pennsylvania, 19103, United States

Location

C&C-Philadelphia

Philadelphia, Pennsylvania, 19154, United States

Location

Southern Solutions Knoxville

Knoxville, Tennessee, 37922, United States

Location

C&C-Arlington

Arlington, Texas, 76015, United States

Location

Sago Dallas

Dallas, Texas, 75254, United States

Location

CRG Test America-Grapevine

Grapevine, Texas, 76051, United States

Location

Sago Houston

Houston, Texas, 77027, United States

Location

C&C-Humble

Humble, Texas, 77338, United States

Location

C&C-Mesquite

Mesquite, Texas, 75150, United States

Location

C&C-San Antonio

San Antonio, Texas, 78216, United States

Location

C&C-San Antonio

San Antonio, Texas, 78224, United States

Location

MeSH Terms

Conditions

Smoking; Tobacco Use; Tobacco Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Melissa Tapia, Ph.D.

  RAIS Service Co

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: September 15, 2025
• Study Start: September 17, 2025
• Primary Completion: January 14, 2026
• Study Completion: January 14, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (27)