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

26 oktober 2016 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

987

Fase

  • Fase 4

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Faculteitstoewijzing
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 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
Geneesmiddel: 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
Actieve vergelijker: 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
Geneesmiddel: 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

Gedragsmatig: 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.
Andere namen:
  • Cognitive Medication Adherence Counseling
Actieve vergelijker: 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.
Geneesmiddel: 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

Geneesmiddel: 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.

Andere namen:
  • Nicotine polacrilex
Actieve vergelijker: 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.
Geneesmiddel: 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

Gedragsmatig: 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.
Andere namen:
  • Cognitive Medication Adherence Counseling
Geneesmiddel: 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.

Andere namen:
  • Nicotine polacrilex
Actieve vergelijker: 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
Geneesmiddel: 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
Actieve vergelijker: 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
Geneesmiddel: 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

Gedragsmatig: 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.
Andere namen:
  • Cognitive Medication Adherence Counseling
Actieve vergelijker: 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.
Geneesmiddel: 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

Geneesmiddel: 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.

Andere namen:
  • Nicotine polacrilex
Actieve vergelijker: 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.
Geneesmiddel: 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

Gedragsmatig: 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.
Andere namen:
  • Cognitive Medication Adherence Counseling
Geneesmiddel: 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.

Andere namen:
  • Nicotine polacrilex

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
7-Day Point Prevalence Abstinence From Smoking by Intervention
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incremental Cost-Effectiveness Ratio for 7-Day Point Prevalence Abstinence From Smoking at 26 Weeks Post-Quit by Nicotine Replacement Therapy (NRT) Group
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Wisconsin, Madison

Medewerkers

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

Onderzoekers

  • Hoofdonderzoeker: Stevens S Smith, PhD, University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
  • Studie directeur: Paula A Keller, MPH, University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 april 2010

Primaire voltooiing (Werkelijk)

1 februari 2011

Studie voltooiing (Werkelijk)

1 november 2011

Studieregistratiedata

Eerst ingediend

15 maart 2010

Eerst ingediend dat voldeed aan de QC-criteria

15 maart 2010

Eerst geplaatst (Schatting)

16 maart 2010

Updates van studierecords

Laatste update geplaatst (Schatting)

8 december 2016

Laatste update ingediend die voldeed aan QC-criteria

26 oktober 2016

Laatst geverifieerd

1 oktober 2016

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • H2009-0074
  • 1RC1CA144382-01 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

Ja

Beschrijving IPD-plan

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

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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