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Telephone Counseling and the Distribution of Nicotine Patches to Smokers

11. februar 2020 oppdatert av: Shu-Hong Zhu, University of California, San Diego

The Efficacy of Telephone Counseling and the Centralized Distribution of Nicotine Replacement Therapy Through a Smoking Cessation Quitline

The primary purpose of this study is to determine the effects of distributing free nicotine replacement therapy (NRT) to tobacco quitline callers directly. Specifically, this study aims to:

  1. Test if sending active nicotine patches directly will lead to a higher quit rate, compared to a condition where the quitline assists the smokers to obtain patches by other means (e.g. via their health plans).
  2. Test if sending placebo patches directly will also lead to a higher quit rate.
  3. Test if quitline counseling increases the quit rate when the smokers already receive the nicotine patches.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Studies have shown that statewide tobacco quitlines can dramatically increase call volume by offering direct mailings of free nicotine replacement therapy (NRT) products. Sending free NRT such as patches to quitline callers, however, often requires a large budget because quitlines have a large number of smokers calling for help each year. A strong rationale is needed for state funding agencies to pay for the patches, which are generally considered the responsibility of health plans. This study will contrast the condition of sending nicotine patches directly from the quitline with a condition where the quitline assists smokers to obtain patches by other means, primarily through their health plans. The study aims to demonstrate that sending patches immediately after smokers call the quitline has a motivational effect that will lead to a higher quit rate than if smokers have to obtain the patches themselves, even if they are able to obtain them for free. To tease apart how much of the effect of sending patches directly from the quitline is due to the active ingredient in the patches and how much is due to motivational effects, this study adds a placebo condition. We hypothesize that the active patches condition will outperform the placebo condition, and the sending of placebo patches will outperform the condition in which the smokers obtain the nicotine patches themselves. We also hypothesize that counseling has its own effect on quitting above and beyond that of the nicotine patches. This study will supply data that can be used to decide what role nicotine replacement therapy should play in publicly funded tobacco cessation programs. Results will also add to the theoretical understanding of behavior change from which new, effective interventions can spring.

Studietype

Intervensjonell

Registrering (Faktiske)

4200

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • California
      • San Diego, California, Forente stater, 92111
        • University of Californian, San Diego: California Smokers' Helpline

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • >= 18 years old
  • Daily smoker
  • >=6 cigarettes per day
  • Ready to quit within one month
  • First time quitline caller
  • Valid phone number
  • Valid address (no P.O. boxes)
  • California resident
  • Agree to participate in study and evaluation
  • English or Spanish speaking

Exclusion Criteria:

  • Uses other form of tobacco
  • Use of Zyban or Chantix
  • One of the following conditions: Severe allergy to adhesive tape, Arrhythmia, Angina, Heart attack within last year, Stroke within last year, Uncontrolled high blood pressure, Insulin-dependent diabetes, Pregnancy

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Faktoriell oppgave
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Active patches and telephone counseling
Proactive Telephone Counseling and 8-weeks of nicotine patches
Legemiddel: Nicotine Patch
Subjects are randomized into 1 of 3 conditions: active, placebo or usual care. Usual care subjects are not mailed patches; however, we facilitate their use by providing a certificate that can be used by the State Medicaid program and some insurance companies to obtain free patches. For those mailed patches directly, we will mail 8 weeks of patches. Dosage depends on the number of cigarettes per day (cpd). Light smokers (6-10 cpd) will receive 6 weeks of 14 mg and 2 weeks of 7 mg patches. Heavy smokers (11+ cpd) will receive 4 weeks of 21 mg, 2 weeks of 14 mg and 2 weeks of 7 mg patches. Placebo patches will have no nicotine, but will be packaged to mimic the active patches.
Andre navn:
  • Habitrol
Atferdsmessig: Telephone Counseling

Subjects call the Helpline and are screened for services. Eligible clients who give consent will be randomly assigned to a group.

Subjects will be randomized into one of 2 behavioral conditions: telephone counseling or self-help materials. Telephone counseling includes a comprehensive pre-quit session (to include motivation, planning, and setting of a quit date and discussion of nicotine patch use) plus up to 5 proactive follow-up calls. Telephone counseling has several distinguishing features, namely proactive follow up counseling calls, a manualized protocol, and relapse-sensitive scheduling.
Placebo komparator: Placebo patches and telephone counseling
Proactive Telephone Counseling and 8-weeks of placebo patches
Atferdsmessig: Telephone Counseling

Subjects call the Helpline and are screened for services. Eligible clients who give consent will be randomly assigned to a group.

Subjects will be randomized into one of 2 behavioral conditions: telephone counseling or self-help materials. Telephone counseling includes a comprehensive pre-quit session (to include motivation, planning, and setting of a quit date and discussion of nicotine patch use) plus up to 5 proactive follow-up calls. Telephone counseling has several distinguishing features, namely proactive follow up counseling calls, a manualized protocol, and relapse-sensitive scheduling.

Legemiddel: Placebo
Placebo nicotine patch
Andre navn:
  • Non-nicotine patch
Aktiv komparator: Telephone counseling
Proactive Telephone Counseling
Atferdsmessig: Telephone Counseling

Subjects call the Helpline and are screened for services. Eligible clients who give consent will be randomly assigned to a group.

Subjects will be randomized into one of 2 behavioral conditions: telephone counseling or self-help materials. Telephone counseling includes a comprehensive pre-quit session (to include motivation, planning, and setting of a quit date and discussion of nicotine patch use) plus up to 5 proactive follow-up calls. Telephone counseling has several distinguishing features, namely proactive follow up counseling calls, a manualized protocol, and relapse-sensitive scheduling.
Aktiv komparator: Active patches and materials
8-weeks of nicotine patches and materials
Legemiddel: Nicotine Patch
Subjects are randomized into 1 of 3 conditions: active, placebo or usual care. Usual care subjects are not mailed patches; however, we facilitate their use by providing a certificate that can be used by the State Medicaid program and some insurance companies to obtain free patches. For those mailed patches directly, we will mail 8 weeks of patches. Dosage depends on the number of cigarettes per day (cpd). Light smokers (6-10 cpd) will receive 6 weeks of 14 mg and 2 weeks of 7 mg patches. Heavy smokers (11+ cpd) will receive 4 weeks of 21 mg, 2 weeks of 14 mg and 2 weeks of 7 mg patches. Placebo patches will have no nicotine, but will be packaged to mimic the active patches.
Andre navn:
  • Habitrol
Annen: Self-Help Materials

Subjects call the Helpline and are screened for services. Eligible clients who give consent will be randomly assigned to a group.

Subjects will be randomized into one of 2 behavioral conditions: telephone counseling or self-help materials. Reading materials and written consent will be mailed to all study subjects the next business day.
Aktiv komparator: Placebo patches and materials
8-weeks placebo patches and materials
Legemiddel: Placebo
Placebo nicotine patch
Andre navn:
  • Non-nicotine patch
Annen: Self-Help Materials

Subjects call the Helpline and are screened for services. Eligible clients who give consent will be randomly assigned to a group.

Subjects will be randomized into one of 2 behavioral conditions: telephone counseling or self-help materials. Reading materials and written consent will be mailed to all study subjects the next business day.
Aktiv komparator: Materials
Self-help materials
Annen: Self-Help Materials

Subjects call the Helpline and are screened for services. Eligible clients who give consent will be randomly assigned to a group.

Subjects will be randomized into one of 2 behavioral conditions: telephone counseling or self-help materials. Reading materials and written consent will be mailed to all study subjects the next business day.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Number of Participants With Six-month Continuous Abstinence From Cigarettes
Tidsramme: 7 months post enrollment
7 months post enrollment

Sekundære resultatmål

Resultatmål
Tidsramme
Number of Participants Quit for 30-days at 2-months Post Enrollment
Tidsramme: 2-months post enrollment
2-months post enrollment

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of California, San Diego

Samarbeidspartnere

California Department of Health Services

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. februar 2009

Primær fullføring (Faktiske)

1. oktober 2010

Studiet fullført (Faktiske)

1. desember 2011

Datoer for studieregistrering

Først innsendt

24. februar 2009

Først innsendt som oppfylte QC-kriteriene

24. februar 2009

Først lagt ut (Anslag)

25. februar 2009

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

13. februar 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. februar 2020

Sist bekreftet

1. februar 2020

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CDPH 05-45834

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

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