Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Pager-Assisted Smoking Cessation Treatment (Pager)

29. oktober 2017 opdateret af: Timothy Carmody, University of California, San Francisco
The proposed study tests the efficacy of using pager-assisted messages combined with nicotine patches in facilitating smoking cessation and relapse prevention in a 2-arm randomized clinical trial. The hypothesis is that the proportion of biochemically-verified quitters at 3 and 12 months in the study arm randomized to receive therapeutic messages on alphanumeric pagers for 3 months along with individual smoking cessation counseling and nicotine patches will be greater that the proportion of biochemically-verified quitters who receive only individual smoking cessation counseling and nicotine patches.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

A total of 224 current smokers were enrolled in a randomized controlled smoking cessation trial. Participants were community-living adult smokers of ≥10 cigarettes per day during the pre-enrollment week who were interested in quitting and recruited from the local area by means of print, media, and online advertisements. To be eligible, they needed to be smoking 10 or more cigarettes per day, aged 18 or older, motivated to quit smoking, prepared to set a quit date, willing to use nicotine patches, and able to come to therapy sessions and be followed by telephone. Participants in the pager treatment were provided with alpha-numeric pagers free of charge for three months. Using specially-designed communication software, text messages were sent to participants aimed at facilitating motivation to quit, cessation strategies, and coping skills to maintain abstinence. Participants in both treatment groups were seen for two 60-minute sessions of standard smoking cessation counseling, and received three follow-up phone calls and two months of nicotine patches.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

224

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • San Francisco, California, Forenede Stater, 94121
        • San Francisco Veterans Affairs Medical Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • smoking 10 or more cigarettes per day
  • aged 18 or older
  • motivated to quit smoking and prepared to set a quit date
  • willing to use nicotine patches
  • ability to come to therapy sessions and be followed by telephone

Exclusion Criteria:

  • individuals who are psychotic
  • severely depressed
  • organically brain impaired
  • actively abusing alcohol or other substances, and/or who have been drug dependent during the past six months
  • terminally ill
  • unable to be contacted by phone,currently using nicotine replacement or smoking cessation medications
  • those with contraindications to nicotine patches, female smokers who are pregnant or breastfeeding

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Pager Arm
Participants in the Pager Arm will be provided with alphanumeric pagers and will receive therapeutic messages on these pagers for 3 months in addition to individual smoking cessation counseling and nicotine patches.
Adfærdsmæssigt: smoking cessation counseling
two 60-minute face-to-face treatment sessions and three 20-minute follow-up contacts at weeks 2, 3, and 9
Andre navne:
  • Adfærdsrådgivning
Medicin: Nicotine patch
8 weeks' worth of nicotine patches
Andre navne:
  • Nicoderm
Enhed: alphanumeric pager
therapeutic messages to be delivered for three months
Andre navne:
  • Pager-assisted text messaging
Aktiv komparator: Control Arm
Participants in the Control Arm will receive individual smoking cessation counseling and nicotine patches.
Adfærdsmæssigt: smoking cessation counseling
two 60-minute face-to-face treatment sessions and three 20-minute follow-up contacts at weeks 2, 3, and 9
Andre navne:
  • Adfærdsrådgivning
Medicin: Nicotine patch
8 weeks' worth of nicotine patches
Andre navne:
  • Nicoderm

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
biologically-validated point prevalence smoking cessation
Tidsramme: 12 months after enrollment
Abstinence from cigarettes "even a puff", other tobacco products and nicotine replacement for seven days at the 12 month follow-up date as validated by salivary cotinine less than 15 ng/ml
12 months after enrollment

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
continuous abstinence from cigarettes "even a puff", tobacco products and nicotine replacement
Tidsramme: 12 months after enrollment
maintained cessation from smoking, biologically-validated by repeated measures of salivary cotinine less than 15 ng/ml at 12 months
12 months after enrollment

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of California, San Francisco

Efterforskere

  • Ledende efterforsker: Timothy P Carmody, Ph.D, University of California, San Francisco

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. maj 2003

Primær færdiggørelse (Faktiske)

1. december 2005

Studieafslutning (Faktiske)

1. december 2005

Datoer for studieregistrering

Først indsendt

21. september 2010

Først indsendt, der opfyldte QC-kriterier

21. september 2010

Først opslået (Skøn)

22. september 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

31. oktober 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. oktober 2017

Sidst verificeret

1. oktober 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 11RT0009

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med smoking cessation counseling

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Argentina

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner