Switch or Quit R01

Cigarette Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06373679
• Other study ID #: Pro00125514
• Secondary ID: 1R01DA056445-01A
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: August 2027

Study information

• Verified date: June 2024
• Source: Medical University of South Carolina
• Contact: Tracy Smith, PhD
• Phone: (843)-792-5164
• Email: smithtra[@]musc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 225
• Est. completion date: August 2027
• Est. primary completion date: May 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cigarette Smoking
• Smoking Behaviors

Intervention

Behavioral:
• Switching to E-Cigarette
Participants will receive eleven weeks of e-cigarette products with instructions to switch completely at switch date
• Switching using Medication
Participants will receive eleven weeks of FDA approved medication, either varenicline or combination NRT, with instructions to quit smoking cigarettes at quit date

Locations

Country	Name	City	State
United States	Medical Univeristy of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biochemically-confirmed 7-day point prevalence abstinence from cigarettes on timeline followback	Self-reported zero cigarettes in the past 7 days on timeline followback at Week 11 + expired carbon monoxide < 6 ppm	11 Weeks
Secondary	Greater than 50% reduction in cigarette smoking	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	11 Weeks