The Options 2 Study

Официальное название

A Randomized Comparative Effectiveness Trial of Nicotine Pouches for Cigarette Substitution: A Question of Public Health

Обзор

The goal of this clinical trial is to investigate how well nicotine pouches and nicotine mini lozenges serve as substitutes for cigarettes when people try to switch from smoking to using these alternate nicotine products. Participants will: * Use nicotine pouches, nicotine mini lozenges, or no study product for a week and then try not to smoke for 3 weeks. * Have 6 in-person research visits and 1 follow-up call * Complete questionnaires at each study contact and use a smartphone app to record smoking and study product use

Подробное описание

Researchers currently lack critical data needed to appraise the potential for nicotine pouches to benefit public health. Specifically, they do not know how readily smokers will adopt pouches, how effectively they can substitute for cigarettes when smokers are trying to avoid smoking, the role of nicotine dose in the ability of pouches to serve as a substitute, or the mechanisms that facilitate or hinder successful product transition. This study will address these questions using a 4-arm randomized controlled trial of adults who smoke ≥5 cigarettes daily and are not planning to quit smoking in the next 30 days. This study will provide a rigorous evaluation of the potential efficacy of a relatively modified risk new nicotine product as a substitute for combusted cigarettes. The head-to-head comparison with FDA-approved mini lozenges can inform tobacco regulatory policy decisions.

Вмешательства

• Препарат Nicotine Pouches
  nicotine pouches
• Препарат Mini Nicotine lozenges
  mini lozenges

Первичные конечные точки

• Mean number of cigarettes smoked per day during the 21-day switching period. [Срок оценки: Baseline to 3 weeks]

Вторичные конечные точки (3)

• Change in cigarette craving [Срок оценки: Baseline to 3 weeks]
• Mean units of study product used per day during the 7-days prior to the switching period [Срок оценки: For 7-days leading up to the switching period]
• Mean units of study product used per day during the 21-day of the switching period [Срок оценки: 21-days of the switching period]

Критерии участия

Критерии включения

• ≥ 21 years old (i.e., able to legally purchase tobacco products)
• able to read and communicate in English
• no plans to quit smoking in the next 30 days
• willing to stop using nicotine replacement or varenicline
• willing to stop using bupropion (i.e., Wellbutrin, Zyban) if they are currently using it only for smoking cessation
• smoking ≥ 5 cigarettes per day for the past 6 months
• exhaled carbon monoxide ≥ 6 ppm
• no nicotine pouch or smokeless tobacco (including snus) use within the last 6 months

Критерии исключения

• currently in treatment for psychosis or bipolar disorder
• currently taking bupropion for non-smoking cessation reasons (e.g., Wellbutrin for depression)
• currently pregnant or breastfeeding

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Wisconsin — Madison

Идентификаторы

NCT: NCT06595459 · 2024-1016 · A534253 · Protocol Version 8/22/25 · 1R01CA291761-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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