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NCT Number: NCT06373679

Switch or Quit R01

This study evaluates whether non-cigarette tobacco products (e-cigarettes) can help smokers quit smoking as compared to traditional quit methods (nicotine replacement therapy or varenicline/Chantix). Participants in this study will be randomly assigned to one of two groups, then will have a choice between the offered products of that group. Participants in the e-cigarette group will have a choice of e-cigarette brand and flavor. Participants in the medication group will have choice between nicotine replacement therapy (patches and lozenges) or varenicline, also known as Chantix. Participation will last 6 months and will include weekly phone calls for the initial 7-weeks plus a 11-week phone call and a 6-month follow-up visit. Participants will also complete electronic daily diaries during the first 7-weeks.

Recruiting

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical Univeristy of South Carolina

Charleston, South Carolina, 29425, United States

Location status: Recruiting

Location contact

Tracy Smith, PhD

CONTACT

[email protected]

8437925164

About this study

Even though e-cigarettes have risen in prevalence over the last decade, data on the use of these products as harm reduction tools for smokers who try to switch completely is lacking.

These data are urgently needed for several reasons.

  • Clinicians cannot provide clear guidance to smokers who may be interested in switching. Questions from medical patients about e-cigarettes are on the rise, and data show that medical providers are providing mixed messages about the safety and utility of e-cigarettes, with some physicians discouraging their use and some recommending them as cessation aids.
  • Public health organizations are also providing mixed messages about the health risks of non-cigarette tobacco products-with some not recommending their use at all (The American Cancer Society, American Lung Association), and some acknowledging that complete switching to e-cigarettes would reduce health risks compared to continued smoking, but not recommending the use of these products over traditional methods (Centers for Disease Control, Food and Drug Administration).
  • In the absence of clear messaging about non-cigarette products, smokers who fail with traditional methods are continuing to smoke cigarettes, the most harmful tobacco product available.

The reviews underscore the need for additional data on this topic, especially data comparing the products to pharmacotherapy. The goal of the proposed study is to provide one of the first well-designed randomized controlled trials that addresses whether alternative tobacco products (e-cigarettes) have the potential to serve as harm reduction tools in a critical population-smokers who have tried to quit smoking using FDA-approved pharmacotherapy and failed to do so.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults 21+ who previously had a quit attempt using FDA-approved pharmacotherapy.
  • Interest in reducing harms from tobacco use or quitting smoking

Exclusion criteria

  • Pregnant, breastfeeding, or trying to become pregnant.
  • Household member currently enrolled in the study
  • Planning to move out of the area within the next 7 months

Treatment and study plan

Switching to E-cigarette

Behavioral

Participants will receive eleven weeks of e-cigarette products with instructions to switch completely at switch date

Switching using Medication

Behavioral

Participants will receive eleven weeks of FDA approved medication, either varenicline or combination NRT, with instructions to quit smoking cigarettes at quit date

Primary outcomes

  1. Biochemically-confirmed 7-day point prevalence abstinence from cigarettes on timeline followback

    Time frame: 11 Weeks

    Self-reported zero cigarettes in the past 7 days on timeline followback at Week 11 + expired carbon monoxide < 6 ppm

Secondary outcomes

  1. Greater than 50% reduction in cigarette smoking

    Time frame: 11 Weeks

    Average reduction in the number of cigarettes smoked per day on 7-day timeline followback at Week 11 of at least 50% or greater compared to average baseline number of cigarettes smoked per day on 7 day timeline followback

Study contacts

Contact information is provided by the study sponsor or research team.

Hana Thamer

CONTACT

[email protected]

(843)-876-2430

Tracy Smith, PhD

CONTACT

[email protected]

(843)-792-5164

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Non-cigarette Tobacco Products as Harm Reduction Tools in Smokers Who Failed to Quit With Traditional Methods

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Apr 18, 2024
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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