A Clinical Trial of Adaptive Treatment for Early Smoking Cessation Relapse

Обзор

This is a research study to find out if treatment decision making can be improved for smokers who find it difficult to quit with medications. Everyone who participates in this study will receive free product, either nicotine replacement therapies (patches and lozenges), varenicline, or a harm reduction product (e-cigarette) for a full 12 weeks. Most participants will receive some combination of these treatments, depending on individual response to each. All visits and study assessments will be entirely remote. All treatments will be provided free of charge for the first 12 weeks. After that, the study team will contact the participants 6 months after the first study phone call to complete another survey. The study lasts six months and will involve 8 surveys.

Подробное описание

Treatment seeking smokers across both Alabama and South Carolina (N=544) will be recruited and consented through established online methods and randomized to receive a 4-week course of either varenicline or combination NRT (patch + lozenge), counterbalanced. Using a concrete and measurable indicator of early treatment success (3 days non-smoking), smokers demonstrating early success at 4 week follow-up will continue with another four weeks of same medication, either varenicline or combination NRT. Those who do not demonstrate early success will be randomized to a subsequent 4-week course of either a) continuation of same medication, or b) switch to the other FDA approved option, either varenicline or combination NRT. The same process will repeat at Week 8, wherein treatment responders will continue with their ongoing medication and non-responders will be randomized to a final 4-week course of either a) continuation of same medication or b) switch to an e-cigarette. End of treatment outcomes will be assessed at Week 12 at which time no more product will be offered. Final follow-up at Week 24 will ascertain all primary (cessation) and secondary outcomes.

Вмешательства

• Поведенческое Switching to a different medication
  Participants will receive four weeks of the other FDA approved option, either varenicline or combination NRT, with instructions to try to quit again at week 4.
• Поведенческое Continued use of the same medication
  Participants will receive four additional weeks of the same medication (varenicline or NRT) with instructions to try to quit again at week 4.
• Поведенческое Switching to a harm reduction tobacco product
  Participants will receive four weeks of e-cigarette products with instructions to switch completely at Week 8

Первичные конечные точки

• Non-responders after initial course of FDA-approved medication [Срок оценки: 8 weeks]

Вторичные конечные точки (1)

• Dependence and duration of longest quit attempt [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

• Smokers who want to quit

Критерии исключения

• Non-smokers

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Medical University of South Carolina — Charleston

Идентификаторы

NCT: NCT06118502 · 00128175 · 1R01CA284649-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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