- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT00309296
Longitudinal Care: Smoking Reduction to Aid Cessation
Longitudinal Care: Smoking Reduction to Aid Cessation; Part of Hatsukami's Tobacco Exposure Reduction
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Objective The objective of this project is to conduct a randomized controlled trial to compare 1) an extended quality care smoking cessation treatment delivered over a one-year period (EQC) to 2) quality care smoking cessation treatment delivered over an 8 week period (QC) to determine if EQC improves prolonged smoking abstinence.
Research Design/Methodology 500 smokers who are interested in quitting will be enrolled and randomly assigned to the EQC or QC groups. Both groups will initially receive a state-of-the-science smoking cessation intervention including behavioral and pharmacological components, delivered by a combination of in-person and telephone care. EQC participants who fail to quit, reduce but do not quit, or relapse will receive intensive treatment over the ensuing 12 months that encourages repeat quit attempts and smoking reduction if they are not to quit. We propose reduction as an intermediate goal in LC because this may increase the likelihood of cessation, increase self-efficacy and keep smokers and clinicians engaged. Reduction treatment will include behavioral treatment and nicotine replacement. QC participants will only receive occasional prompts to quit. The primary endpoint will be 6M of abstinence measured 18M after enrollment. Secondary endpoints will include point prevalent abstinence, smoking reduction, self-efficacy and satisfaction. We will also collect qualitative data from successful abstainers and reducers about decision making processes and intervention experiences.
Clinical Significance This project will address the potential role of smoking reduction in the treatment menu for smokers interested in quitting. This project examines mechanisms, methods and a "real world" application for reducing toxin exposure.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Minnesota
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Minneapolis, Minnesota, Spojené státy, 55417
- Minneapolis VAMC
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Age 18-80
- Current and regular smoker 5 or more cigarettes per day
- Interested in making a quit attempt in the next 14 days
- Personal phone available
Exclusion Criteria:
- Pregnancy or plans to become pregnant in the next year
- Cannot speak English
- Not a union member or employee of specified worksite or immediate family member
- Member of household is currently enrolled in the study
- Not willing to comply with study protocol
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Longitudinal Care
One year of combined behavioral and pharamcological tobacco dependence treatment, with interim smoking reduciton for smokers who fail initial quit attempt.
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This was a randomized controlled trial to compare long-term smoking cessation outcomes between Longitudinal Care (LC) and Usual Care (UC) treatment groups.
The LC group received smoking cessation treatment (combined behavioral and pharmacological therapies) for one-year period.
This treatment recommended repeat quit attempts or smoking reduction for those who failed to quit after the initial attempt.
The UC group received evidence-based treatment that lasted 8 weeks.
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Aktivní komparátor: Usual Care
Evidence based, state-of-the-science tobacco treatment; combined behavioral and pharmacological treatment for 8 weeks
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This was a randomized controlled trial to compare long-term smoking cessation outcomes between Longitudinal Care (LC) and Usual Care (UC) treatment groups.
The LC group received smoking cessation treatment (combined behavioral and pharmacological therapies) for one-year period.
This treatment recommended repeat quit attempts or smoking reduction for those who failed to quit after the initial attempt.
The UC group received evidence-based treatment that lasted 8 weeks.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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The primary endpoint will be 6M of abstinence measured 18M after enrollment.
Časové okno: 18M
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6M prolonged abstinence
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18M
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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7d point prevalent abstinence
Časové okno: 18M
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Data collected at 21d, 3, 6, 12, 18M
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18M
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30d point prevalent abstinence
Časové okno: 18M
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Data collected at 3, 6, 12, 18M
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18M
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Smoking reduction
Časové okno: 18M
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Data collected at 3, 6, 12, 18M
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18M
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Total duration of abstinence
Časové okno: 18M
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Time Line Follow Back
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18M
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Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Anne M Joseph, MD, MPH, University of Minnesota
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- TLC (Trichotillomania Learning Center)
- P50DA013333-07 (Grant/smlouva NIH USA)
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