- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00786149
Improving Varenicline Adherence and Outcomes in Homeless Smokers
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Despite significant declines in cigarette smoking rates among adults in the United States in the last few decades, smoking rates remain high among poor and underserved populations. One underserved group is the 4 million homeless persons in the US among whom cigarette smoking rate is an alarming 70% or more; these rates are 3 times higher than national average. Two of the three leading causes of death among homeless persons, heart disease and cancer are tobacco related.2, 3 Despite very high smoking prevalence and disease burden in this population smoking cessation research have not been extended to the homeless. Recent studies including data from our research team show a considerable degree of readiness to quit smoking by homeless smokers and that nicotine replacement therapy (NRT) plus counseling show promise. However, homeless persons face many challenges that may constitute barriers for them to adhere to smoking cessation treatments even if such treatments have been proven effective in the general population. In order to reduce smoking-related health disparities within this underserved population, it is critical that cessation interventions including strategies to improve treatment adherence be developed to include homeless smokers. The primary aim of this study is to assess the effects of adherence-focused motivational interviewing (MI) to help homeless persons quit smoking.
Recruitment and retention will be enhanced by use of bus passes for transportation, debit cards, attractive intervention materials, collaboration with homeless shelters, and advice from a community advisory board. If successful, this study will provide a model for how to overcome barriers to cancer prevention services among homeless persons. It will also provide the impetus for policy changes directed at increasing homeless persons' access to smoking cessation pharmacotherapy and treatment.
Studietype
Registrering (Faktiske)
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
-
-
Minnesota
-
Minneapolis, Minnesota, Forente stater, 55414
- University of Minnesota
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- currently homeless
- smoke 5 or more cigarettes per day
- smoked 100 cigarettes in lifetime
- aged 18 years or older
Exclusion Criteria:
- unstable mental illness
- pregnancy
- current history of psychoactive or alcohol dependence or psychotic disorder
- cognitive impairment
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 1
Participants will receive NRT and Motivational Interviewing counseling
|
Motivational Interviewing; 8 weeks of counseling
Andre navn:
|
|
Aktiv komparator: 2
Varenicline plus brief advice
|
Brief advice, one time during initial session
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
7-day point prevalence abstinence from smoking
Tidsramme: 6 months after enrollment
|
6 months after enrollment
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Adherence to treatment
Tidsramme: 12 weeks and 6 months after enrollment
|
12 weeks and 6 months after enrollment
|
|
Moderating effects of psychiatric co-morbidities and other substance abuse on treatment
Tidsramme: 6 months after enrollment
|
6 months after enrollment
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Kolawole S Okuyemi, MD,MPH, University of Minnesota
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Ojo-Fati O, Joseph AM, Ig-Izevbekhai J, Thomas JL, Everson-Rose SA, Pratt R, Raymond N, Cooney NL, Luo X, Okuyemi KS. Practical issues regarding implementing a randomized clinical trial in a homeless population: strategies and lessons learned. Trials. 2017 Jul 5;18(1):305. doi: 10.1186/s13063-017-2046-9.
- Ojo-Fati O, Thomas JL, Vogel RI, Ogedegbe O, Jean-Louis G, Okuyemi KS. Predictors of Adherence to Nicotine Replacement Therapy (Nicotine Patch) Among Homeless Persons Enrolled in a Randomized Controlled Trial Targeting Smoking Cessation. J Fam Med. 2016;3(7):1079. Epub 2016 Sep 6.
- Goldade K, Whembolua GL, Thomas J, Eischen S, Guo H, Connett J, Des Jarlais D, Resnicow K, Gelberg L, Owen G, Grant J, Ahluwalia JS, Okuyemi KS. Designing a smoking cessation intervention for the unique needs of homeless persons: a community-based randomized clinical trial. Clin Trials. 2011 Dec;8(6):744-54. doi: 10.1177/1740774511423947.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 0708M14444
- HL081522
- NIH-522
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