Clinical trial NCT06373679: Switch or Quit R01
Official title: Non-cigarette Tobacco Products as Harm Reduction Tools in Smokers Who Failed to Quit With Traditional Methods
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cigarette Smoking
Smoking Behaviors
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2024-04-18
Enrollment: 225
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

1. 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.
2. 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).
3. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Biochemically-confirmed 7-day point prevalence abstinence from cigarettes on timeline followback
timeFrame: 11 Weeks
Secondary outcomes:
measure: Greater than 50% reduction in cigarette smoking
timeFrame: 11 Weeks
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical Univeristy of South Carolina
state: South Carolina
Study officials:
affiliation: smithtra@musc.edu
name: Tracy Smith
role: PRINCIPAL_INVESTIGATOR
References: