- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02683161
Pre to Postoperative Smoking Cessation
19. juni 2018 oppdatert av: 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.
Studieoversikt
Status
Avsluttet
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
5
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Maryland
-
Baltimore, Maryland, Forente stater, 21224
- Johns Hopkins Bayview Medical Center
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 100 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Annen: 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.
|
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 navn:
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 navn:
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Change in Smoking Status
Tidsramme: Assessed starting in week 2 of 12 weekly study visits
|
Smoking abstinence is defined the change in number of self-reported cigarettes smoked per week
|
Assessed starting in week 2 of 12 weekly study visits
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Kelly E Dunn, Ph.D., Johns Hopkins University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. oktober 2015
Primær fullføring (Faktiske)
1. juli 2017
Studiet fullført (Faktiske)
1. juli 2017
Datoer for studieregistrering
Først innsendt
15. oktober 2015
Først innsendt som oppfylte QC-kriteriene
10. februar 2016
Først lagt ut (Anslag)
17. februar 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
17. juli 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
19. juni 2018
Sist bekreftet
1. juni 2018
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IRB00071969
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
The study was ended prematurely due to lack of recruitment.
Data analysis is not possible and will not be reported.
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Varenicline
-
Assistance Publique - Hôpitaux de ParisUkjentRøykeslutt | Røyking, sigarett | Elektronisk sigarettFrankrike