Combination Nicotine Replacement Therapy, Cytisine, or Varenicline for Smoking Cessation

Официальное название

Combination Nicotine Replacement Therapy, Cytisine, or Varenicline for Smoking Cessation: A Randomized Controlled Trial

Обзор

The purpose of this vanguard trial is to test whether clients of Sun Life are willing to join in a quit smoking program that offers counselling and tobacco cessation products to all participants over a 12-month period. The study team will track the safety and usage of 3 types of cessation products as well as the effectiveness of a virtual pharmacy (i.e. cessation products delivered to participants directly from a pharmacy). The goal is to recruit a minimum of 150 participants for this Vanguard phase. The purpose of this study is to look at 3 approved smoking cessation products used in combination with counselling and virtual delivery of the smoking cessation products. The goal is to track product usage, safety, and adherence (how much of the products people use and how many counselling sessions they complete). Within the study there will also be an observational group who will not receive study medication but who will receive free virtual coaching and follow-up for smoking cessation and complete study questionnaires.

Подробное описание

This vanguard study will engage people who smoke through an insurance-based outreach program (Sun Life Assurance Company of Canada) to evaluate the efficacy and safety of three pharmacotherapy arms (combination NRT, cytisine, or varenicline) within the OMSC framework, which includes the provision of cost-free virtual counselling, follow-up, and direct-to-consumer delivery of medications.

To our knowledge, there are no prior studies evaluating an entirely virtual smoking cessation intervention which includes virtual counselling/follow-up and direct-to-consumer delivery of pharmacotherapy. This study will also engage the broader community setting, such as clients or employees of industry partners, represents a valuable opportunity to reach a wider population of people who smoke with tailored support. Beyond cost savings associated with smoking cessation, this study may also reduce insurance premiums for patients, thus leading to additional source of cost savings.

The goal is to recruit a minimum of 150 participants for this Vanguard phase. If successful, recruitment will continue until the budget is finished, or, until additional funding is received to support a full-scale trial (N=1650 participants).

Вмешательства

• Препарат Nicotine Replacement Therapy (Nicotine patch plus NRT gum or lozenge)
  Participants in this group will apply 1 NRT patch each morning for up to 26 weeks. Patches will be titrated based on cigarettes consumed. Short-acting NRT products (gum and lozenge) will be used as needed by the participants in this group.
• Препарат Cytisine
  Participants in this group will take 3mg of cytisine 3 times per day for 12 weeks.
• Препарат Varenicline (Champix)
  Participants in this group will take 1mg of varenicline 2 times per day for 12 weeks.

Первичные конечные точки

• Participant's Smoking Status [Срок оценки: 6 months]

Вторичные конечные точки (9)

• Participant's Smoking Status at follow-up [Срок оценки: 1, 3, and 12 months]
• Number of quit attempts made by participant [Срок оценки: 6, and 12 months]
• Participant's level of nicotine dependance [Срок оценки: 6, and 12 months]
• Participant's heaviness of smoking score [Срок оценки: 6, and 12 months]
• Participant's adherence to the counselling program [Срок оценки: 12 months]
• Participant's adherence to study medication [Срок оценки: 6 months]
• Participant's response to smoking cessation quality of life questionnaire [Срок оценки: Baseline, 6 and 12 months]
• Participant's response to the Patient Health Questionnaire (PHQ-9) [Срок оценки: Baseline, 6 and 12 months]
• Participant's response to the General Anxiety Disorder Questionnaire (GAD-7) [Срок оценки: Baseline, 6 and 12 months]

Критерии участия

Критерии включения

• Adults (≥18 years)
• Current cigarette smokers (more than 5 cigarettes per day) who are interested in reducing or quitting in the next 6 months.
• Able to provide informed consent.
• Living in Ontario, Canada

Критерии исключения

• Contraindications to any of the study medications (NRT, cytisine, varenicline).
• Actively using one of the study medications in the past 7 days.
• Actively enrolled in another formal smoking cessation program.
• Pregnant or breastfeeding individuals.
• Unable to engage in follow-up for any reason (for example an acute mental illness, cognitive impairment, unable to speak English or French).
• Other conditions deemed by the study team to interfere with participation or outcomes in the opinion of the study investigator (for example acutely unwell, life expectancy less than 1 year).

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• University of Ottawa Heart Institute — Ottawa

Идентификаторы

NCT: NCT06832085 · 20240741-01H

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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