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Telephone Counseling and the Distribution of Nicotine Patches to Smokers

11 febbraio 2020 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

4200

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • California
      • San Diego, California, Stati Uniti, 92111
        • University of Californian, San Diego: California Smokers' Helpline

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione fattoriale
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Active patches and telephone counseling
Proactive Telephone Counseling and 8-weeks of nicotine patches
Droga: 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.
Altri nomi:
  • Habitrol
Comportamentale: 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.
Comparatore placebo: Placebo patches and telephone counseling
Proactive Telephone Counseling and 8-weeks of placebo patches
Comportamentale: 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.

Droga: Placebo
Placebo nicotine patch
Altri nomi:
  • Non-nicotine patch
Comparatore attivo: Telephone counseling
Proactive Telephone Counseling
Comportamentale: 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.
Comparatore attivo: Active patches and materials
8-weeks of nicotine patches and materials
Droga: 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.
Altri nomi:
  • Habitrol
Altro: 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.
Comparatore attivo: Placebo patches and materials
8-weeks placebo patches and materials
Droga: Placebo
Placebo nicotine patch
Altri nomi:
  • Non-nicotine patch
Altro: 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.
Comparatore attivo: Materials
Self-help materials
Altro: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Number of Participants With Six-month Continuous Abstinence From Cigarettes
Lasso di tempo: 7 months post enrollment
7 months post enrollment

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
Number of Participants Quit for 30-days at 2-months Post Enrollment
Lasso di tempo: 2-months post enrollment
2-months post enrollment

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of California, San Diego

Collaboratori

California Department of Health Services

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 febbraio 2009

Completamento primario (Effettivo)

1 ottobre 2010

Completamento dello studio (Effettivo)

1 dicembre 2011

Date di iscrizione allo studio

Primo inviato

24 febbraio 2009

Primo inviato che soddisfa i criteri di controllo qualità

24 febbraio 2009

Primo Inserito (Stima)

25 febbraio 2009

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 febbraio 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

11 febbraio 2020

Ultimo verificato

1 febbraio 2020

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CDPH 05-45834

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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