- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02683161
Pre to Postoperative Smoking Cessation
19. juni 2018 opdateret af: Johns Hopkins University
The study will evaluate the feasibility of integrating an intensive pre- post-surgical smoking cessation intervention into a hospital setting, and assess measures of postsurgical recovery as a function of smoking cessation status.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This study will evaluate the feasibility of integrating an intensive pre- post-surgical smoking cessation intervention (i.e., varenicline + monetary incentives + brief counseling) into a hospital setting by recruiting elective bariatric surgery patients and assessing theoretically relevant baseline characteristics (e.g., factors influencing smoking decisions, such as smoking motivation, delayed discounting, and distress tolerance) that may predict smoking cessation and post-surgical recovery outcomes.
Participants will be required to attend a screening visit at the Behavioral Pharmacology Research Unit (BPRU) located on the Johns Hopkins Bayview Medical Campus, during which the participants will answer questionnaires, complete computerized tasks, and undergo sensory testing.
Participants will then attend approximately 6 weekly study visits leading up to their bariatric surgery, and approximately 6 more weekly study visits after the surgery, as well as a 30-day follow-up visit, all located at the BPRU at Johns Hopkins Bayview.
During the 6 pre-surgery visits and 6 post-surgery visits, participants will undergo an intensive smoking cessation treatment that includes administration of a medication called varenicline that has been FDA-approved for smoking cessation, as well as behavioral counseling sessions and monetary incentives for remaining smoke-free.
After completing all study visits, participants will be asked to return for a 30-day follow-up visit, during which they will complete several study measures once more.
Throughout the study, participants will be asked to periodically complete questionnaires, computerized tasks, and sensory testing.
Investigators will also track outcomes associated with post-surgical recovery, including duration of hospital stay, hospital readmission, post-surgical complications, and prescription pain-killer use post-surgery.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
5
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Maryland
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Baltimore, Maryland, Forenede Stater, 21224
- Johns Hopkins Bayview Medical Center
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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 100 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Smoker who has surgery scheduled 5-10 weeks in advance
Exclusion Criteria:
- being contraindicated for varenicline use
- evidence of psychiatric instability
- being unwilling/unable to adhere to the study schedule
- be unwilling to provide study access to medical records
- being otherwise judged by the study team to be inappropriate for study participation
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: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Andet: Open-label trial
All participants will attend approximately 6 study sessions pre-surgery and approximately 6 study sessions post-surgery, during which they will be provided three intervention components aimed at smoking cessation: a medication (varenicline) that has been FDA approved for smoking cessation, contingency management for biological evidence of nonsmoking, and behavioral counseling.
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Varenicline will be administered as clinically indicated and will begin approximately 4-6 weeks prior to surgery.
All participants will receive a 1-week dose induction period before transitioning to a full maintenance dose.
Andre navne:
Contingency Management payments will begin on the target quit date (week 2) and will be in place for 5 weeks or until surgery (whichever is sooner).
Participants will receive monetary incentives for biochemical evidence of smoking abstinence.
Andre navne:
All participants will complete a 3-session behavioral counseling intervention with a trained member of our study staff during 3 of the pre-surgical study visits.
This brief counseling intervention provides participants with information about the experience of quitting smoking, including a benefits/disadvantage analysis, functional analysis of craving/risk periods, and skills-building exercises to prevent lapse and relapse.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Change in Smoking Status
Tidsramme: Assessed starting in week 2 of 12 weekly study visits
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Smoking abstinence is defined the change in number of self-reported cigarettes smoked per week
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Assessed starting in week 2 of 12 weekly study visits
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Kelly E Dunn, Ph.D., Johns Hopkins 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. oktober 2015
Primær færdiggørelse (Faktiske)
1. juli 2017
Studieafslutning (Faktiske)
1. juli 2017
Datoer for studieregistrering
Først indsendt
15. oktober 2015
Først indsendt, der opfyldte QC-kriterier
10. februar 2016
Først opslået (Skøn)
17. februar 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
17. juli 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. juni 2018
Sidst verificeret
1. juni 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IRB00071969
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
The study was ended prematurely due to lack of recruitment.
Data analysis is not possible and will not be reported.
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 .
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