Tobacco and Socioeconomic Disadvantage
13. november 2019 opdateret af: Marc L. Steinberg, Ph.D., Rutgers, The State University of New Jersey
Addressing Tobacco Use Among Those At Socioeconomic Disadvantage
Randomized clinical trial comparing 3 brief interventions designed to increase motivation to quit smoking in socioeconomically disadvantaged smokers.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
The investigators propose a randomized clinical trial comparing 3 brief interventions designed to increase motivation to quit smoking in socioeconomically disadvantaged smokers.
Participants will be randomly assigned to receive a) A brief motivational interviewing intervention, b) A nicotine replacement therapy sampling intervention, or c) A referral-only intervention.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
58
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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New Jersey
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New Brunswick, New Jersey, Forenede Stater, 08901
- Division of Addiction Psychiatry
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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 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Participants must be between the age of 19 and 65
- Participants must self-report being a daily smoker and provide biochemical verification of smoking status (expired breath carbon monoxide reading >5)
- Participants must be at socioeconomic disadvantage, defined as receiving services at a New Brunswick, New Jersey based social services agency (i.e., living in New Brunswick Housing Authority-run public housing units or requesting social services from the community social service agency, "Elijah's Promise")
- Participants must be able to speak and read English.
Exclusion Criteria:
- Participants may not be taking FDA approved smoking cessation or anti-psychotic medications
- Participants may not reported medical issues of potential concern to nicotine replacement users (e.g., unstable angina pectoris, myocardial infarction, or significant cardiac arrythmia (including atrial fibrillation) in the past 30 days)
- Participants may not report pending legal issues with potential to result in incarceration.
- Participants may not be pregnant or nursing, planning on becoming pregnant in the next two months, and must be using effective birth control.
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: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Motivational Interviewing
35 minute individual motivational interviewing intervention concluding with a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line
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Participants are provided with a 35 minute counseling session designed to increase motivation to quit smoking and then provided with a written referral for tobacco dependence treatment.
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Aktiv komparator: Nicotine Replacement Therapy Sampling
Participants are provided with a 2-week supply of nicotine patches and a 2 week supply of nicotine lozenges with a recommendation to try them and are also given a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line.
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Participants are provided with a two-week sample of over-the-counter nicotine replacement therapy (i.e., nicotine lozenge and nicotine patch) and then provided with a written referral for tobacco dependence treatment.
Andre navne:
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Andet: Referral Only
Participants are provided with a written referral sheet for a local smoking cessation clinic and the New Jersey State Quit Line.
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Participants are provided with a written referral for tobacco dependence treatment.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Self-reported Serious Quit Attempt Measured Via the 'Quitting Preparation and Actions Questionnaire'
Tidsramme: 30 days
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A self-described "serious" attempt to quit smoking cigarettes since the initial study appointment, measured by the "Quitting Preparation and Actions Questionnaire."
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30 days
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Self-reported Treatment Seeking Measured Via the 'Quitting Preparation and Actions Questionnaire'
Tidsramme: 30 days
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Self-reported contact with one of two treatment referrals provided at intervention since the time of the initial study appointment
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30 days
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Self-reported Cigarettes Per Day
Tidsramme: 30 days
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Self-reported cigarettes smoked per day; abstinence to be biochemically verified with carbon monoxide < 5ppm
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30 days
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Importance, Confidence, & Readiness Questionnaire
Tidsramme: 30 days
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Motivation and Self-efficacy for quitting smoking measured via Importance, Confidence, & Readiness Questionnaire" (rated on a 0 to 10 scale with higher numbers indicating greater importance, confidence, or readiness to quit)
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30 days
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Readiness to Quit Ladder
Tidsramme: 30 days
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"Readiness to Quit Ladder" (with 10 non-numbered choices, ranging from 0 to 10 reflecting varying degrees of readiness to quit smoking; higher numbers reflect greater readiness to quit smoking)
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30 days
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Marc L Steinberg, Ph.D., Rutgers Robert Wood Johnson Medical School
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 (Faktiske)
30. maj 2018
Primær færdiggørelse (Faktiske)
1. oktober 2018
Studieafslutning (Faktiske)
1. oktober 2018
Datoer for studieregistrering
Først indsendt
29. juni 2018
Først indsendt, der opfyldte QC-kriterier
6. august 2018
Først opslået (Faktiske)
8. august 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
15. november 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
13. november 2019
Sidst verificeret
1. november 2019
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Pro20170000679
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Ingen
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ja
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