- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00309296
Longitudinal Care: Smoking Reduction to Aid Cessation
Longitudinal Care: Smoking Reduction to Aid Cessation; Part of Hatsukami's Tobacco Exposure Reduction
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Minnesota
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Minneapolis, Minnesota, Stati Uniti, 55417
- Minneapolis VAMC
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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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Comparatore attivo: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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The primary endpoint will be 6M of abstinence measured 18M after enrollment.
Lasso di tempo: 18M
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6M prolonged abstinence
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18M
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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7d point prevalent abstinence
Lasso di tempo: 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
Lasso di tempo: 18M
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Data collected at 3, 6, 12, 18M
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18M
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Smoking reduction
Lasso di tempo: 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
Lasso di tempo: 18M
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Time Line Follow Back
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18M
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Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Anne M Joseph, MD, MPH, University of Minnesota
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- TLC (Trichotillomania Learning Center)
- P50DA013333-07 (Sovvenzione/contratto NIH degli Stati Uniti)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .