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Improving the Population-Wide Effectiveness of U.S. Tobacco Cessation Quitlines

26 octobre 2016 mis à jour par: University of Wisconsin, Madison
Research shows that smoking cessation is the most significant preventable health behavior change that a person can make to lower cancer risk. In addition, telephone quitlines are an effective, science-based smoking cessation treatment that is universally accessible to smokers in the U.S. However, little research has explored promising approaches that could increase quitline use, improve quit rates, and inform resource allocation for quitline services. The proposed study will test three promising enhancements to the standard quitline treatment that typically consists of counseling and, possibly 2 weeks of a NRT medication. These enhancements are: 1) combination nicotine replacement therapy as recommended by the United States Public Health Service Clinical Practice Guideline on Treating Tobacco Use and Dependence; 2) extended duration of cessation medication use; and 3) an innovative counseling addition - cognitive medication adherence counseling - to optimize adherence to cessation medication. In addition, the cost-effectiveness of each intervention will be calculated. The findings of the proposed research have broad potential application and relevance to state quitlines, quitline service providers, and other purchasers of quitline services such as employers and insurers. Additionally, the study findings can potentially inform other telephone health behavior counseling programs.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

The study design is a fully crossed 2x2x2 factorial design that tested the effect of two versus six weeks of nicotine replacement therapy (NRT), the effect of NRT monotherapy (nicotine patch alone) versus NRT combination therapy (nicotine patch + oral NRT), and the effect of cognitive medication adherence counseling (CMAC) versus no CMAC. A total of 987 smokers seeking cessation assistance from the Wisconsin Tobacco Quit Line (WTQL) were randomly assigned to the eight (2x2x2) different conditions generated by the three experimental factors. This design provides us with sufficient power to analyze each of our three main effects listed above. We will also test for two- and three-way interactions, but do not have sufficient data to make a priori assumptions about interaction effects. Finally, we will conduct a cost-effectiveness analysis for each of the three interventions to allow readers of this research to evaluate whether the additional costs of the interventions yield sufficient gains to warrant implementing them broadly.

Type d'étude

Interventionnel

Inscription (Réel)

987

Phase

  • Phase 4

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Washington
      • Seattle, Washington, États-Unis, 98104
        • Wisconsin Tobacco Quit Line (service provided by Free & Clear, Inc.)
    • Wisconsin
      • Madison, Wisconsin, États-Unis, 53711
        • University of Wisconsin Center for Tobacco Research and Intervention

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

The only people eligible for this study are Wisconsin residents who contact the Wisconsin Tobacco Quit Line for smoking cessation services.

Inclusion Criteria:

  • Callers will be eligible to participate in the study if they are English speaking; are 18 years of age or older; smoke a minimum of 10 cigarettes per day; are interested in quitting and are willing to set a quit date; willing and able to use nicotine patch and nicotine gum; agree to receive four follow-up counseling calls from Free & Clear (the quitline vendor for the State of Wisconsin); provide verbal informed consent; and provide contact information and agree to take four study follow-up calls from staff at the University of Wisconsin Center for Tobacco Research and Intervention.

Exclusion Criteria:

  • Callers will be excluded if they are under the age of 18; are pregnant or breastfeeding; exclusively use other forms of tobacco (e.g., smokeless tobacco); are unwilling or unable to use study NRT medications; are currently using a cessation medication (NRT, bupropion, varenicline); or have medical exclusions as per FDA-approved product labeling.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation factorielle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: 2 Weeks of Nicotine Patch Only, No CMAC

Participants in this randomization arm received 2 weeks of nicotine patch and standard cessation counseling (but no Cognitive Medication Adherence Counseling)

2 Weeks of Nicotine patch dosed as follows:

If > 10 cigs/day: one 21 mg nicotine patch per day for 2 weeks

If < or = 10 cigs/day: one 14 mg nicotine patch per day for 2 weeks
Médicament: Nicotine patch

If > 10 cigs/day: one 21 mg nicotine patch per day

If < or = 10 cigs/day: one 14 mg nicotine patch per day
Comparateur actif: 2 Weeks of Nicotine Patch Only plus CMAC

Participants in this randomization arm received 2 weeks of nicotine patch and standard cessation counseling plus Cognitive Medication Adherence Counseling

2 Weeks of Nicotine patch dosed as follows:

If > 10 cigs/day: one 21 mg nicotine patch per day for 2 weeks

If < or = 10 cigs/day: one 14 mg nicotine patch per day for 2 weeks
Médicament: Nicotine patch

If > 10 cigs/day: one 21 mg nicotine patch per day

If < or = 10 cigs/day: one 14 mg nicotine patch per day

Comportemental: CMAC
CMAC consists of tailored cessation counseling to improve medication adherence during the counseling calls. The CMAC protocol was developed by study investigators and involved: (1) pre-quit assessment of beliefs that might undermine NRT adherence; (2) on-going medication adherence assessment by quitline Quit Coaches; and (3) tailored coaching based on the ongoing assessments.
Autres noms:
  • Cognitive Medication Adherence Counseling
Comparateur actif: 2 Wks Nicotine Patch+Nic Gum, No CMAC

Participants in this randomization arm received 2 weeks of nicotine patch plus nicotine gum and standard cessation counseling (but no Cognitive Medication Adherence Counseling)

2 Weeks of Nicotine patch dosed as follows:

If > 10 cigs/day: one 21 mg nicotine patch per day for 2 weeks

If < or = 10 cigs/day: one 14 mg nicotine patch per day for 2 weeks

2 Weeks of Nicotine gum dosed as follows:

If < 25 cigs/day, 2 mg nicotine gum for 2 weeks, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects.

If ≥ 25 cigs/day, 4 mg nicotine gum for 2 weeks, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects.
Médicament: Nicotine patch

If > 10 cigs/day: one 21 mg nicotine patch per day

If < or = 10 cigs/day: one 14 mg nicotine patch per day

Médicament: Nicotine gum

If < 25 cigs/day, 2 mg nicotine gum, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects.

If ≥ 25 cigs/day, 4 mg nicotine gum, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects.

Autres noms:
  • Nicotine polacrilex
Comparateur actif: 2 Wks Nicotine Patch+Nic Gum plus CMAC

Participants in this randomization arm received 2 weeks of nicotine patch and nicotine gum plus standard cessation counseling and Cognitive Medication Adherence Counseling

2 Weeks of Nicotine patch dosed as follows:

If > 10 cigs/day: one 21 mg nicotine patch per day for 2 weeks

If < or = 10 cigs/day: one 14 mg nicotine patch per day for 2 weeks

2 Weeks of Nicotine gum dosed as follows:

If < 25 cigs/day, 2 mg nicotine gum for 2 weeks, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects.

If ≥ 25 cigs/day, 4 mg nicotine gum for 2 weeks, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects.
Médicament: Nicotine patch

If > 10 cigs/day: one 21 mg nicotine patch per day

If < or = 10 cigs/day: one 14 mg nicotine patch per day

Comportemental: CMAC
CMAC consists of tailored cessation counseling to improve medication adherence during the counseling calls. The CMAC protocol was developed by study investigators and involved: (1) pre-quit assessment of beliefs that might undermine NRT adherence; (2) on-going medication adherence assessment by quitline Quit Coaches; and (3) tailored coaching based on the ongoing assessments.
Autres noms:
  • Cognitive Medication Adherence Counseling
Médicament: Nicotine gum

If < 25 cigs/day, 2 mg nicotine gum, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects.

If ≥ 25 cigs/day, 4 mg nicotine gum, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects.

Autres noms:
  • Nicotine polacrilex
Comparateur actif: 6 Weeks of Nicotine Patch Only, No CMAC

Participants in this randomization arm received 6 weeks of nicotine patch and standard cessation counseling (but no Cognitive Medication Adherence Counseling)

6 Weeks of Nicotine patch dosed as follows:

If > 10 cigs/day: one 21 mg nicotine patch per day for 6 weeks

If < or = 10 cigs/day: one 14 mg nicotine patch per day for 6 weeks
Médicament: Nicotine patch

If > 10 cigs/day: one 21 mg nicotine patch per day

If < or = 10 cigs/day: one 14 mg nicotine patch per day
Comparateur actif: 6 Weeks of Nicotine Patch Only plus CMAC

Participants in this randomization arm received 6 weeks of nicotine patch and standard cessation counseling plus Cognitive Medication Adherence Counseling

6 Weeks of Nicotine patch dosed as follows:

If > 10 cigs/day: one 21 mg nicotine patch per day for 6 weeks

If < or = 10 cigs/day: one 14 mg nicotine patch per day for 6 weeks
Médicament: Nicotine patch

If > 10 cigs/day: one 21 mg nicotine patch per day

If < or = 10 cigs/day: one 14 mg nicotine patch per day

Comportemental: CMAC
CMAC consists of tailored cessation counseling to improve medication adherence during the counseling calls. The CMAC protocol was developed by study investigators and involved: (1) pre-quit assessment of beliefs that might undermine NRT adherence; (2) on-going medication adherence assessment by quitline Quit Coaches; and (3) tailored coaching based on the ongoing assessments.
Autres noms:
  • Cognitive Medication Adherence Counseling
Comparateur actif: 6 Wks Nicotine Patch+Nic Gum, No CMAC

Participants in this randomization arm received 6 weeks of nicotine patch plus nicotine gum and standard cessation counseling (but no Cognitive Medication Adherence Counseling)

6 Weeks of Nicotine patch dosed as follows:

If > 10 cigs/day: one 21 mg nicotine patch per day for 6 weeks

If < or = 10 cigs/day: one 14 mg nicotine patch per day for 6 weeks

6 Weeks of Nicotine gum dosed as follows:

If < 25 cigs/day, 2 mg nicotine gum for 6 weeks, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects.

If ≥ 25 cigs/day, 4 mg nicotine gum for 6 weeks, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects.
Médicament: Nicotine patch

If > 10 cigs/day: one 21 mg nicotine patch per day

If < or = 10 cigs/day: one 14 mg nicotine patch per day

Médicament: Nicotine gum

If < 25 cigs/day, 2 mg nicotine gum, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects.

If ≥ 25 cigs/day, 4 mg nicotine gum, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects.

Autres noms:
  • Nicotine polacrilex
Comparateur actif: 6 Wks Nicotine Patch+Nic Gum plus CMAC

Participants in this randomization arm received 6 weeks of nicotine patch and nicotine gum plus standard cessation counseling and Cognitive Medication Adherence Counseling

6 Weeks of Nicotine patch dosed as follows:

If > 10 cigs/day: one 21 mg nicotine patch per day for 6 weeks

If < or = 10 cigs/day: one 14 mg nicotine patch per day for 6 weeks

6 Weeks of Nicotine gum dosed as follows:

If < 25 cigs/day, 2 mg nicotine gum for 6 weeks, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects.

If ≥ 25 cigs/day, 4 mg nicotine gum for 6 weeks, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects.
Médicament: Nicotine patch

If > 10 cigs/day: one 21 mg nicotine patch per day

If < or = 10 cigs/day: one 14 mg nicotine patch per day

Comportemental: CMAC
CMAC consists of tailored cessation counseling to improve medication adherence during the counseling calls. The CMAC protocol was developed by study investigators and involved: (1) pre-quit assessment of beliefs that might undermine NRT adherence; (2) on-going medication adherence assessment by quitline Quit Coaches; and (3) tailored coaching based on the ongoing assessments.
Autres noms:
  • Cognitive Medication Adherence Counseling
Médicament: Nicotine gum

If < 25 cigs/day, 2 mg nicotine gum, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects.

If ≥ 25 cigs/day, 4 mg nicotine gum, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects.

Autres noms:
  • Nicotine polacrilex

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
7-Day Point Prevalence Abstinence From Smoking by Intervention
Délai: 26 weeks after the target quit smoking date
Self-reported total abstinence from any tobacco use (even a single puff) for the seven days preceding the target follow-up day.
26 weeks after the target quit smoking date
7-Day Point Prevalence Abstinence From Smoking by Nicotine Replacement Therapy (NRT) Group
Délai: 26 weeks after the target quit smoking date
Self-reported total abstinence from any tobacco use (even a single puff) for the seven days preceding the target follow-up day.
26 weeks after the target quit smoking date

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Incremental Cost-Effectiveness Ratio for 7-Day Point Prevalence Abstinence From Smoking at 26 Weeks Post-Quit by Nicotine Replacement Therapy (NRT) Group
Délai: 26 weeks after the target quit smoking date
For cost analyses, we computed the costs of intervention per caller, the cost per quit based on the 6-month ITT 7-day PPA, and the incremental cost-effectiveness ratio (ICER. Intervention costs included direct costs associated with registration, provision of NRT and counseling (standard and MAC), and mailing of a quit guide (all participants) and a MAC information sheet (MAC participants only). Facility space, supplies, and physician supervision time were included in the call costs; research-related costs were excluded. ICER ratio is a measure of the added cost per added quit for two treatments. ICER was computed as the cost difference between the least intensive treatment group (2 weeks of nicotine patch only) and a more intensive comparison group divided by the difference in the quit rates of the two groups being compared; e.g., the ICER for the group that received 2 weeks of nicotine patch and nicotine gum = (213-178)/(.482-.384) = $357.
26 weeks after the target quit smoking date

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Wisconsin, Madison

Collaborateurs

National Cancer Institute (NCI)
Department of Health and Human Services
Consumer Wellness Solutions
Wisconsin Department of Health and Family Services

Les enquêteurs

  • Chercheur principal: Stevens S Smith, PhD, University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
  • Directeur d'études: Paula A Keller, MPH, University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 avril 2010

Achèvement primaire (Réel)

1 février 2011

Achèvement de l'étude (Réel)

1 novembre 2011

Dates d'inscription aux études

Première soumission

15 mars 2010

Première soumission répondant aux critères de contrôle qualité

15 mars 2010

Première publication (Estimation)

16 mars 2010

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

8 décembre 2016

Dernière mise à jour soumise répondant aux critères de contrôle qualité

26 octobre 2016

Dernière vérification

1 octobre 2016

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • H2009-0074
  • 1RC1CA144382-01 (Subvention/contrat des NIH des États-Unis)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

Oui

Description du régime IPD

Upon request, clinical trial data will be shared with other investigators in the form of de-identified datasets. Requests can be sent to Stevens S. Smith, Ph.D., at sss@ctri.wisc.edu

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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