Project Q: Cue-based Treatment Intervention to Promote Cessation Among People Who Smoke Lightly or Non-daily

Официальное название

Feasibility of Cue-based Treatment Intervention to Promote Cessation Among People Who Smoke Lightly (≤10 Cigarettes Per Day) or Non-daily

Обзор

This study aims to test the feasibility and acceptability of a remotely delivered cue-based treatment intervention to promote smoking cessation among people who smoke lightly or non-daily. Secondary objectives include assessing preliminary efficacy on cessation and examining cue reactivity. Participants will be randomized to CBT only or CBT + cue-based treatment, with assessments at baseline, end-of-treatment, 6 months, and 12 months.

Вмешательства

• Поведенческое Cognitive Behavioral Therapy (CBT)
  CBT delivered via telehealth sessions and supportive text messages.
• Поведенческое Cue-based treatment intervention
  Cue-based treatment includes exposure to smoking-related cues and coping strategies.

Первичные конечные точки

• Feasibility as measured by the number of participants who are recruited and randomized [Срок оценки: During the recruitment period (up to 9 months)]
• Feasibility as measured by the number of participants who respond to pre-quit real-time data collection [Срок оценки: End of treatment (up to 12 months)]
• Feasibility as measured by the number of participants who take pictures of smoking/craving situations [Срок оценки: End of treatment (up to 12 months)]
• Feasibility as measured by the number of participants who complete all CBT (cognitive behavioral therapy) sessions [Срок оценки: End of treatment (up to 12 months)]
• Feasibility as measured by the number of participants who complete all cue-based treatment sessions [Срок оценки: End of treatment (up to 12 months)]
• Feasibility as measured by the number of participants who respond to EMA text based assessments [Срок оценки: End of treatment (up to 12 months)]
• Feasibility as measured by the number of participants who proactively text to report cravings [Срок оценки: End of treatment (up to 12 months)]
• Acceptability of CBT + cue-based treatment intervention compared to CBT only [Срок оценки: End of treatment (up to 12 months)]

Вторичные конечные точки (6)

• Number of participants reporting the presence of smoking cues [Срок оценки: 7 days after end of each CBT session (4 sessions total)]
• Craving level [Срок оценки: 7 days after end of each CBT session (4 sessions total)]
• Stress level [Срок оценки: 7 days after end of each CBT session (4 sessions total)]
• Current mood [Срок оценки: 7 days after end of each CBT session (4 sessions total)]
• Number of participants who reported 30-day point prevalence abstinence [Срок оценки: End of Treatment, 6 months]
• Smoking status as measured by salivary cotinine [Срок оценки: End of Treatment, 6 months]

Критерии участия

Критерии включения

• Age ≥18
• Able to read and understand English or Spanish
• Smoke 1-10 cigarettes/day on at least 4 days of the past two weeks for the last year
• Willing to try quitting in next 30 days
• Access to cell phone with texting capabilities

Критерии исключения

• Current participation in another smoking cessation study
• Unable to provide consent
• Refusal to abstain from e-cigarettes or other tobacco products
• Use of medications affecting smoking cessation (e.g., Chantix, Wellbutrin)

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

• Duke University — Durham

Идентификаторы

NCT: NCT07425119 · Pro00117950 · 1R34CA304591

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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