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- Klinische proef NCT00170079
Prolonged Smoking Cessation Using Prescription Step Care
Smoking is the number one preventable cause of morbidity and mortality in this nation. Unfortunately, more than 50% of those who quit following a smoking cessation intervention typically relapse within two weeks, with approximately 80% relapsing within six months. Therefore, tobacco use can be conceptualized as a chronic condition. As with many chronic medical problems, tobacco use interventions may benefit from a step care approach to treatment.
A total of 400 adult smokers will be enrolled in the study. Participants will be randomly assigned to one of two treatment conditions consisting of: 1) A State of the Art Smoking Cessation Intervention + Recycling or: 2) A State of the Art Smoking Cessation Intervention + Step Care. Long term smoking cessation will be assessed by self-report, exhaled carbon monoxide levels, and salivary cotinine. The primary endpoint of the study will be smoking abstinence rates at two-year follow-up. It is predicted that long-term cessation rates will be significantly higher in the step care condition than for those assigned to the recycling group.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
A common approach to increasing long-term adherence and control of chronic medical problems such as hypertension in both general and preventive medicine is the concept of step care. Despite a high degree of interest in applying the step care model to smoking cessation (Abrams et al., 1996; Hughes, 1994), little empirical work has been conducted utilizing this treatment approach. The purpose of this study is to evaluate the long-term efficacy of a step care model for smoking cessation that is disseminable in primary care settings. With that introduction, we propose the following specific aims:
Aim 1: To enroll approximately 400 adult cigarette smokers recruited mainly from primary care settings;
Aim 2: To randomize these participants to: 1) State of the Art Smoking Cessation + Recycling or 2) State of the Art Smoking Cessation + Step Care; and
Aim 3: To evaluate the long-term (24 months post-randomization) relative success of the interventions. It is predicted that long-term cessation rates will be significantly higher in the step care condition.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Minnesota
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Rochester, Minnesota, Verenigde Staten, 55905
- Mayo Clinic
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Tennessee
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Memphis, Tennessee, Verenigde Staten, 38163
- University of Tennessee
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Step care vs. regular care
Participants were randomized either to (1) Step care intervention, where smokers who failed to quit or who relapsed received increasingly intensive smoking cessation interventions; vs. (2) Regular care, where smokers who failed to quit or who relapsed received repeated intervention.
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A common approach to increasing long-term adherence and control of chronic medical problems such as hypertension in both general and preventive medicine is the concept of "step care." The purpose of this study is to evaluate the long-term efficacy of a step care model for smoking cessation that is disseminable in primary care settings. With that introduction, we propose the following specific aims: Aim 1: To enroll approximately 400 adult cigarette smokers recruited mainly from primary care settings; Aim 2: To randomize these participants to: 1) State of the Art Smoking Cessation + Recycling or 2) State of the Art Smoking Cessation + Step Care; and Aim 3: To evaluate the long-term (24 months post-randomization) relative success of the interventions. It is predicted that long-term cessation rates will be significantly higher in the step care condition. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Long term smoking cessation using both prolonged and point prevalence abstinence criteria
Tijdsspanne: 24 months
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24 months
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Robert C. Klesges, Ph.D., Mayo Clinic
Publicaties en nuttige links
Algemene publicaties
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 1730-04
- R01CA106667-01 (Subsidie/contract van de Amerikaanse NIH)
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
product vervaardigd in en geëxporteerd uit de V.S.
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