- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00309296
Longitudinal Care: Smoking Reduction to Aid Cessation
Longitudinal Care: Smoking Reduction to Aid Cessation; Part of Hatsukami's Tobacco Exposure Reduction
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Minnesota
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Minneapolis, Minnesota, Forente stater, 55417
- Minneapolis VAMC
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 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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Aktiv komparator: Usual Care
Evidence based, state-of-the-science tobacco treatment; combined behavioral and pharmacological treatment for 8 weeks
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
The primary endpoint will be 6M of abstinence measured 18M after enrollment.
Tidsramme: 18M
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6M prolonged abstinence
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18M
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
7d point prevalent abstinence
Tidsramme: 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
Tidsramme: 18M
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Data collected at 3, 6, 12, 18M
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18M
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Smoking reduction
Tidsramme: 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
Tidsramme: 18M
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Time Line Follow Back
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18M
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Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Anne M Joseph, MD, MPH, University of Minnesota
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- TLC (Trichotillomania Learning Center)
- P50DA013333-07 (U.S. NIH-stipend/kontrakt)
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