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Comparing Smoking Treatment Programs for Lighter Smokers - 1

25. juli 2019 opdateret af: University of Pennsylvania

Comparing Smoking Treatment Programs for Lighter Smokers

The purpose of this study was to compare two different types of Food and Drug Administration (FDA) approved smoking cessation medications (nicotine patch or bupropion) used in conjunction with two levels of counseling. It was hypothesized that the higher level of counseling would have the highest rates of treatment completion and highest rates of abstinence.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The study compared a minimal level counseling model to a higher level counseling model plus one of two types of FDA approved smoking cessation products (bupropion or the nicotine patch)used to achieve long term abstinence among lighter smokers. Each participant received both products under blinded conditions meaning that neither the participant nor the counselor knew which product was real or a placebo. The primary goal was to determine the combination or combinations of high or low intensity counseling and pharmacotherapy (either bupropion or the nicotine patch) that were most effective for lighter smokers. The main hypothesis was that higher level counseling would contribute to improved outcomes meaning that more counseling would be associated higher abstinence rates following the completion of treatment and at longer term follow-up.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

260

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19104 6178
        • University of Pennsylvania

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 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Light smokers (6-15 cigarettes per day

Inclusion Criteria:

Mentally and physically stable, non-pregnant, light smokers (6-15 cigarettes per day)

Exclusion Criteria:

Please contact site for more information

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: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 1: Bup+MM
bupropion and MM counseling with placebo patch
Medicin: bupropion
150 mg/day X 3 days 300mg/day for 60 days Total 9 weeks
Andre navne:
  • Zyban
Adfærdsmæssigt: Medication Management
Brief manual based therapy; four 15 minute session over 10 weeks.
Medicin: placebo patch
placebo patch containing no nicotine
Eksperimentel: 2 Bup+Mayo
bupropion and Mayo counseling with placebo patch.
Medicin: bupropion
150 mg/day X 3 days 300mg/day for 60 days Total 9 weeks
Andre navne:
  • Zyban
Medicin: placebo patch
placebo patch containing no nicotine
Adfærdsmæssigt: Mayo Counseling
Manual based therapy; Weekly 30 minute sessions for 10 weeks
Placebo komparator: 3 Patch+MM
patch and MM counseling with placebo pills
Adfærdsmæssigt: Medication Management
Brief manual based therapy; four 15 minute session over 10 weeks.
Medicin: nicotine transdermal system
starting with 21 or 14mg dependent on number of cigarettes per day smoked upon entry in the study; titrated down over 8 weeks.
Andre navne:
  • Nicoderm
Medicin: placebo bupropion
placebo pills
Eksperimentel: 4 Patch+Mayo
patch and Mayo counseling with placebo pills
Adfærdsmæssigt: Mayo Counseling
Manual based therapy; Weekly 30 minute sessions for 10 weeks
Medicin: nicotine transdermal system
starting with 21 or 14mg dependent on number of cigarettes per day smoked upon entry in the study; titrated down over 8 weeks.
Andre navne:
  • Nicoderm
Medicin: placebo bupropion
placebo pills

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percent Treatment Sessions Attended
Tidsramme: 52 weeks

Completion of Treatment and Smoking Cessation by Two Different Types of Medications and Counseling Types at 12, 26, and 52 Weeks Post-treatment Initiation. The counseling types were Medication Management (MM) and Mayo counseling models. MM counseling was a 4 session lower intensity counseling model and Mayo counseling was a 10 session higher intensity model.

A twofold definition of treatment completion included both medication and counseling session adherence. Treatment completion was defined as consistently taking the active medication as prescribed (80%) of the time during the medication period and attending at least 7 of the 10 required High C sessions or 3 of the 4 Low C sessions. Participants had to meet both requirements to be designated as full treatment completers.

Seven-day point prevalence abstinence was the primary measure of abstinence at follow-up Weeks 12, 24, and 52. Abstinence was confirmed by biochemical testing.
52 weeks

Sekundære resultatmål

Resultatmål
Tidsramme
Delineate Mediators Associated With Different Treatment Conditions (i.e., Medication Compliance, Participant Views of Self-help Written Materials and Counseling Type.
Tidsramme: 52 weeks
52 weeks

Samarbejdspartnere og efterforskere

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

Sponsor

University of Pennsylvania

Samarbejdspartnere

National Institute on Drug Abuse (NIDA)

Efterforskere

  • Ledende efterforsker: Peter W Gariti, Ph.D., University of Pennsylvania

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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. september 2003

Primær færdiggørelse (Faktiske)

1. april 2008

Studieafslutning (Faktiske)

1. juni 2009

Datoer for studieregistrering

Først indsendt

1. juli 2004

Først indsendt, der opfyldte QC-kriterier

6. juli 2004

Først opslået (Skøn)

7. juli 2004

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. august 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. juli 2019

Sidst verificeret

1. juli 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NIDA-15365-1
  • R01DA015365 (U.S. NIH-bevilling/kontrakt)

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 bupropion

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Sponsorer og samarbejdspartnere

Medicinske tilstande

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Betingelser

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Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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