Набор скоро начнётся NCT06966362

Varenicline for Smoking Reduction in Veterans Not Ready To Quit

Фаза IV С лечением Veterans Tobacco Use Disorder Cigarette Smoking Tobacco Dependence

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Motivation-Phase Varenicline, Motivation-Phase Nicotine Mini-Lozenge, Cessation-Phase Combination Nicotine Replacement Therapy (NRT), Cessation-Phase Varenicline.
Кому может быть актуально: Состояния в реестре: Veterans, Tobacco Use Disorder, Cigarette Smoking, Tobacco Dependence. Базовые параметры: от 21 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Varenicline for Smoking Reduction in Veterans Unwilling to Quit

Обзор

In order to reduce the prevalence of cigarette smoking among Veterans, it is vital that healthcare providers offer effective tobacco treatment to all Veterans who smoke, including those not ready to make a quit attempt. Smoking treatments currently available to Veterans who are not ready to quit are only weakly effective. This project will generate new knowledge about the effectiveness of a promising varenicline-based intervention designed to increase quit attempts and long-term abstinence in Veterans who are initially not ready to quit. This project has great potential to engage Veterans not ready to quit smoking in treatment that increases quit attempts and quitting success, thereby reducing morbidity and mortality caused by smoking in Veterans.

Подробное описание

Evidence-based smoking cessation treatments can double smoking abstinence rates, yet these treatments are underused by the millions of Veterans who smoke. One reason for this is that the great majority of people who smoke are not ready to make a quit attempt when cessation treatment is offered (70-90%). An important public health goal is to increase engagement of people not ready to quit smoking in highly effective treatment that prepares them to make quit attempts and ultimately achieve abstinence (i.e., Motivation-phase treatment; MPT). MPT typically combines smoking reduction counseling with nicotine replacement therapy (NRT). Although offering NRT Motivation-phase treatment (NRT MPT) in healthcare settings increases the reach of tobacco treatment, such interventions only weakly affect long-term abstinence. It is vital that the investigators develop more effective MPTs that increase quit attempts and quitting success in people not ready to quit. Varenicline, the most effective single agent smoking cessation pharmacotherapy, holds great promise as an intervention for people who are not ready to make a quit attempt. The investigators propose that MPT will be markedly more effective if it involves the use of varenicline (vs. NRT) because it will more effectively reduce smoking reward, affective withdrawal, and tonic craving. Initial evidence suggests that varenicline increases quitting motivation in those not ready to quit, but the extant studies have not 1) directly evaluated varenicline effectiveness in this population and 2) compared varenicline MPT with NRT MPT, the current standard treatment for those not ready to make a quit attempt. The goal of this study is to evaluate whether varenicline MPT is especially effective and cost-effective relative to NRT MPT, in Veterans who are willing to reduce but not quit smoking. This study will compare the use of varenicline MPT vs. NRT MPT on: biochemically verified point-prevalence abstinence at 1 year (primary outcome), quit attempts, and cessation treatment use.

This study is a 2-group randomized controlled trial that will enroll 400 adults from three geographically diverse VA hospitals who smoke 5 cigarettes/day and do not want to quit smoking in the next 30 days but are willing to cut down. Participants will be randomized to one of two 12-week MPT groups: (1) varenicline, or (2) NRT (2 mg mini-lozenges). All participants will receive 5 phone counseling sessions focused on smoking reduction during the 12-week MPT. Any participants who decide to try quitting will receive smoking cessation treatment involving continued use of their assigned study medication and cessation counseling.

Вмешательства

Препарат Motivation-Phase Varenicline
Varenicline reduction dosing will start when participants initiate Motivation-phase treatment: 0.5mg once daily for 3 days, increasing to 0.5mg twice daily for days 4 to 7, and then to the maintenance dose of 1mg twice daily for the duration of the 12-week reduction regimen.
Препарат Motivation-Phase Nicotine Mini-Lozenge
NRT mini-lozenge reduction dosing will start when participants initiate Motivation-phase treatment: 2-mg mini-lozenges in place of cigarettes (5-15/day).
Препарат Cessation-Phase Combination Nicotine Replacement Therapy (NRT)
Combination NRT (nicotine patch + nicotine mini-lozenge) cessation dosing will begin on the target quit day: if smoking \>10 cigarettes/day = 8 weeks of 21-mg, 2 weeks of 14-mg, and 2 weeks of 7-mg nicotine patches; if smoking 10 cigarettes/day = 10 weeks of 14-mg and 2 weeks of 7-mg nicotine patches. All participants will receive 2 or 4 mg mini-lozenge for the 12-week cessation period (9/day, 1 piece every 1-2/hours).
Препарат Cessation-Phase Varenicline
Varenicline cessation dosing will start one week prior to their TQD: 0.5mg once daily for 3 days, increasing to 0.5mg twice daily for days 4 to 7, and then to the maintenance dose of 1mg twice daily for the remainder of the 12-week cessation regimen.
Поведенческое Motivation-Phase Counseling
All participants receive motivation-phase counseling. Motivation-phase counseling involves 5, 10-15-minute counseling calls. The counselor will work with participants on smoking control skills selected by the participant, such as avoidance of smoking cues, reducing smoking heaviness/contexts, developing urge coping skills, or finding support from friends and family. Counseling will emphasize setting realistic and achievable smoking control goals. Counseling will also emphasize competence and sel
Поведенческое Cessation-Phase Counseling
All participants who enter cessation treatment will be offered 4, 10-15-minute counseling calls. The first counseling session involves pre-quit preparation, and can occur any time before the target quit day. The other 3 counseling calls will be scheduled for 1 day, 1 week, and 4 weeks after the target quit date. Cessation counseling will be based on treatment guidelines and will review instructions for when to start cessation medication, the timing of the quit day (relative to medication start),

Первичные конечные точки

7-day point prevalence abstinence [Срок оценки: 6 months post-study entry]

Вторичные конечные точки (3)

Making a quit attempt lasting 24 hours [Срок оценки: 6 and 12 months post-study entry]
Cessation treatment entry [Срок оценки: 6 months post-study entry]
Biochemically confirmed 7-day point-prevalence abstinence [Срок оценки: 12 months post-study entry]

Критерии участия

Критерии включения

Report smoking an average of 5 or more cigarettes daily for the previous 6 months
Not ready to set a quit date in the next 30 days but willing to cut down on their smoking
Able to read, write, and speak English
Be medically eligible to use study medications (NRT or varenicline)
If female, use an approved method of birth control while using study medication
Be at least 21 years old
Be a Veteran