- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00786149
Improving Varenicline Adherence and Outcomes in Homeless Smokers
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- Phase 3
Contacts et emplacements
Lieux d'étude
-
-
Minnesota
-
Minneapolis, Minnesota, États-Unis, 55414
- University of Minnesota
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 1
Participants will receive NRT and Motivational Interviewing counseling
|
Motivational Interviewing; 8 weeks of counseling
Autres noms:
|
|
Comparateur actif: 2
Varenicline plus brief advice
|
Brief advice, one time during initial session
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
7-day point prevalence abstinence from smoking
Délai: 6 months after enrollment
|
6 months after enrollment
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Adherence to treatment
Délai: 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
Délai: 6 months after enrollment
|
6 months after enrollment
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Kolawole S Okuyemi, MD,MPH, University of Minnesota
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 0708M14444
- HL081522
- NIH-522
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .