Switch or Quit R01

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Switching to E-Cigarette
  Participants will receive eleven weeks of e-cigarette products with instructions to switch completely at switch date
• Поведенческое 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

Первичные конечные точки

• Biochemically-confirmed 7-day point prevalence abstinence from cigarettes on timeline followback [Срок оценки: 11 Weeks]

Вторичные конечные точки (1)

• Greater than 50% reduction in cigarette smoking [Срок оценки: 11 Weeks]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Medical Univeristy of South Carolina — Charleston

Идентификаторы

NCT: NCT06373679 · Pro00125514 · 1R01DA056445-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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