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

Evaluation of Learning-Theory-Based Smoking Cessation Strategies

30. marts 2022 opdateret af: Danielle E. McCarthy, Ph.D., Rutgers University
This clinical trial tested whether a new treatment designed to help smokers prepare to quit smoking by practicing quitting several times helped more smokers quit and stay quit than standard treatment with nicotine patch and smoking cessation counseling. The practice quitting treatment tested involved quitting for progressively longer periods of time tailored to individual patterns of smoking. This clinical trial also tested whether non-nicotine cigarettes can help smokers become smoke free after slipping during a stop smoking attempt.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

  • Participants in this study are randomized to one of two treatments conditions prior to a target quit date.

    • One-half of participants will be randomly assigned to receive standard smoking cessation treatment comprising a 6-week supply of 21-mg nicotine patches and 4 individual smoking cessation counseling sessions.
    • The other one-half of participants will be randomly assigned to receive standard treatment (patch and counseling, as above) plus to practice quitting 7 times over the 2.5 weeks leading up to a quit attempt. Practice quitting will involve not smoking for a period of time tailored to each individual's smoking pattern.
  • All participants are asked to attend a 2-hour orientation session, complete 8 brief (5-minute) telephone calls and 9 longer(20-minute) telephone surveys over 3.5 weeks, attend a 30-minute office visit, and complete two 15-minute follow-up calls.
  • All participants are also asked to report on their emotions, thoughts, and behaviors 3 times per day for 24 days using cellular telephones.
  • Participants receive compensation for office visits, study telephone calls, cellular telephone reports, and follow-up interviews.
  • All participants will receive nicotine patches and one-on-one counseling (delivered over the phone and in person).

  • Some participants will be eligible for a second phase of treatment after a 4-week follow-up interview.

    • One-half of people eligible for this phase of the study will be randomly assigned to receive a supply of non-nicotine cigarettes to smoke for up to 6 weeks. The non-nicotine cigarettes are designed to help break the habit of smoking and to help smokers return to being smoke-free after smoking regular cigarettes.
    • The other one-half of eligible smokers will be randomly assigned to not receive these non-nicotine cigarettes.
    • All smokers eligible for this phase of the study will be asked to complete cellular telephone reports about their mood, thoughts, and behaviors for 14 days beginning 4.5 weeks after a target stop-smoking date. Compensation will be provided for completing these cellular telephone phone reports.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

93

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
    • New Jersey
      • New Brunswick, New Jersey, Forenede Stater, 08901
        • Rutgers University Institute for Health, Health Care Policy, and Aging Research

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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • 18 years of age or older
  • Smoke cigarettes daily
  • Motivated to quit smoking
  • Able to read and write English
  • Willing and able to complete study visits and cell phone calls

Exclusion Criteria:

  • Pregnancy, breastfeeding, planning on becoming pregnant during the study
  • Recent heart attack or heart surgery, heart disease, unstable angina
  • Allergy to adhesives
  • Past negative reactions to nicotine patch
  • Serious skin conditions

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
Aktiv komparator: Standard treatment
In this arm, smokers receive a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help them quit smoking
Adfærdsmæssigt: Standard treatment
Standard treatment includes a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help smokers quit smoking
Andre navne:
  • Nikotinplaster
Eksperimentel: Standard treatment+practice quitting
In this arm, participants receive standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling.
Adfærdsmæssigt: Standard treatment+practice quitting
This intervention includes standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling
Andre navne:
  • Nikotinplaster
Eksperimentel: Very low nicotine cigarettes
In this condition, smokers from both the Standard treatment and the Standard treatment+practice quitting arms who have smoked in the last 7-days at a 4-week post-target-smoking-cessation-date follow-up interview may be randomly assigned to this group. Those assigned to this group will receive a 6-week supply of cigarettes that contain tobacco with very low levels of nicotine (in regular or menthol flavors) to smoke instead of regular cigarettes containing nicotine. This treatment is designed to help people stop smoking after slipping (returning to smoking) during an attempt to stop smoking
Medicin: Very low nicotine cigarettes
This intervention will be offered to a subset of smokers from both of the other study arms. To be eligible for this intervention, participants must be smoking at the follow-up interview conducted four weeks after a target quit day in the two arms listed above. Tobacco cigarettes containing very low levels of nicotine (.016-.019 mg in smoke from the cigarettes). These are to be smoked no more often than a smoker normally smokes regular cigarettes and for no longer than 6 weeks.
Ingen indgriben: Advice and encouragement only
In this condition, smokers from both the Standard treatment and the Standard treatment+practice quitting arms who have smoked in the last 7-days at a 4-week post-target-smoking-cessation-date follow-up interview may be randomly assigned to this condition. Those in this arm will receive advice and encouragement to try to stop smoking again after they have slipped (returned to smoking) during a stop smoking attempt.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
4-week Abstinence
Tidsramme: 4 weeks
7-day point prevalence abstinence captures whether participants have used tobacco in the past 7 days at the 4-week post-quit follow-up (i.e., whether any tobacco use occurred in the 4th week of the quit attempt).
4 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
10-week Abstinence
Tidsramme: 10 weeks
This captures whether any tobacco use occurred in the past 7 days at the 10-week follow up (i.e., whether any tobacco use occurred in the 10th week of the quit attempt), as reported by participants in a timeline follow-back telephone interview and confirmed by a follow-up expired carbon monoxide reading less than or equal to 8 parts per million.
10 weeks
Mediators of Treatment Effects: Confidence in Quitting in the Weeks Leading up to the Target Quit Date
Tidsramme: 3 weeks pre-quit
Emotional, mental, and behavioral measures that may help explain treatment effects on tobacco use outcomes will be assessed intensively in the three weeks leading up to a quit attempt and the first week of a quit attempt to examine mediators (confidence in quitting) of the first phase treatment. These repeated measures will be analyzed to see if treatment affects them and if they predict smoking behavior. Confidence related to quitting to for good was rated on a 5-point scale where 1=definitely not confident and 5=definitely confident.
3 weeks pre-quit
Prolonged Abstinence
Tidsramme: 10 weeks
This outcome measures whether regular smoking (7 days in a row) occurred between the 4th and 10th weeks of the quit attempt.
10 weeks

Samarbejdspartnere og efterforskere

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

Sponsor

Rutgers University

Samarbejdspartnere

National Institute on Drug Abuse (NIDA)

Efterforskere

  • Ledende efterforsker: Danielle E McCarthy, Ph.D., Rutgers University

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. juni 2012

Primær færdiggørelse (Faktiske)

1. juli 2013

Studieafslutning (Faktiske)

1. august 2013

Datoer for studieregistrering

Først indsendt

6. juni 2011

Først indsendt, der opfyldte QC-kriterier

6. juni 2011

Først opslået (Skøn)

8. juni 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. april 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. marts 2022

Sidst verificeret

1. marts 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • DA026511
  • 1R21DA026511-01A1 (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 Standard treatment

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Poland

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner