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

26 października 2016 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

987

Faza

  • Faza 4

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przypisanie czynnikowe
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: 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
Lek: 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
Aktywny komparator: 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
Lek: 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

Behawioralne: 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.
Inne nazwy:
  • Cognitive Medication Adherence Counseling
Aktywny komparator: 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.
Lek: 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

Lek: 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.

Inne nazwy:
  • Nicotine polacrilex
Aktywny komparator: 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.
Lek: 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

Behawioralne: 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.
Inne nazwy:
  • Cognitive Medication Adherence Counseling
Lek: 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.

Inne nazwy:
  • Nicotine polacrilex
Aktywny komparator: 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
Lek: 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
Aktywny komparator: 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
Lek: 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

Behawioralne: 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.
Inne nazwy:
  • Cognitive Medication Adherence Counseling
Aktywny komparator: 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.
Lek: 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

Lek: 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.

Inne nazwy:
  • Nicotine polacrilex
Aktywny komparator: 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.
Lek: 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

Behawioralne: 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.
Inne nazwy:
  • Cognitive Medication Adherence Counseling
Lek: 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.

Inne nazwy:
  • Nicotine polacrilex

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
7-Day Point Prevalence Abstinence From Smoking by Intervention
Ramy czasowe: 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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Incremental Cost-Effectiveness Ratio for 7-Day Point Prevalence Abstinence From Smoking at 26 Weeks Post-Quit by Nicotine Replacement Therapy (NRT) Group
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of Wisconsin, Madison

Współpracownicy

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

Śledczy

  • Główny śledczy: Stevens S Smith, PhD, University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
  • Dyrektor Studium: Paula A Keller, MPH, University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 kwietnia 2010

Zakończenie podstawowe (Rzeczywisty)

1 lutego 2011

Ukończenie studiów (Rzeczywisty)

1 listopada 2011

Daty rejestracji na studia

Pierwszy przesłany

15 marca 2010

Pierwszy przesłany, który spełnia kryteria kontroli jakości

15 marca 2010

Pierwszy wysłany (Oszacować)

16 marca 2010

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

8 grudnia 2016

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

26 października 2016

Ostatnia weryfikacja

1 października 2016

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • H2009-0074
  • 1RC1CA144382-01 (Grant/umowa NIH USA)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAk

Opis planu 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

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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