Enhancing Smoking Cessation in the Homeless Population The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Smoking Cessation in Homeless Populations: A Pilot Clinical Trial Kolawole S. Okuyemi, M.D., M.P.H. Program in Health Disparities Research, Department of Family Medicine and Community Health, University of Minnesota Medical School.
Abstract
Introduction:Although homeless individuals smoke at an alarmingly high rate, few smoking cessation clinical trials have focused on this vulnerable population. Little is known about recruitment efforts and suitable eligibility criteria for tobacco control research in homeless populations.Methods:The aim of this article is to describe the recruitment, eligibility, and enrollment of homeless smokers who participated in the Power to Quit smoking study, a randomized smoking cessation clinical trial funded by the National Institutes of Health. The study compared motivational interviewing and standard counseling while participants received an 8-week treatment of the nicotine patch.Results:Working with local emergency shelters, a total of 839 adult smokers were screened for study eligibility, 580 of whom (69.1%) met eligibility criteria. Of those eligible, 430 (74.1%) returned for randomization. Those who returned for randomization were older and more likely to have a phone number compared with eligible participants not enrolled. The most common reasons for exclusion included exhaled carbon monoxide levels less than or equal to 5 parts per million (indicating nonsmoking status), use of smoking cessation aid during the past 30 days, and not meeting the study definition of homelessness.Conclusion:Knowledge of these factors may help researchers tailor criteria that accurately identify and include homeless smokers in future research.
Journal
Nicotine and Tobacco Research – Oxford University Press
Smoking Cessation In Homeless Populations A Pilot Clinical Trial 2017
Published: Mar 24, 2014
Smoking Cessation In Homeless Populations A Pilot Clinical Trials
Background Although smoking prevalence remains strikingly high in homeless populations (~70% and three times the US national average), smoking cessation studies usually exclude homeless persons. Novel evidence-based interventions are needed for this high-risk subpopulation of smokers.
Purpose To describe the aims and design of a first-ever smoking cessation clinical trial in the homeless population. The study was a two-group randomized community-based trial that enrolled participants (n = 430) residing across eight homeless shelters and transitional housing units in Minnesota. The study objective was to test the efficacy of motivational interviewing (MI) for enhancing adherence to nicotine replacement therapy (NRT; nicotine patch) and smoking cessation outcomes.
Smoking Cessation In Homeless Populations A Pilot Clinical Trial 2016
Methods Participants were randomized to one of the two groups: active (8 weeks of NRT + 6 sessions of MI) or control (NRT + standard care). Participants attended six in-person assessment sessions and eight retention visits at a location of their choice over 6 months. Nicotine patch in 2-week doses was administered at four visits over the first 8 weeks of the 26-week trial. The primary outcome was cotinine-verified 7-day point-prevalence abstinence at 6 months. Secondary outcomes included adherence to nicotine patch assessed through direct observation and patch counts. Other outcomes included the mediating and/or moderating effects of comorbid psychiatric and substance abuse disorders.
Results Lessons learned from the community-based cessation randomized trial for improving recruitment and retention in a mobile and vulnerable population included: (1) the importance of engaging the perspectives of shelter leadership by forming and convening a Community Advisory Board; (2) locating the study at the shelters for more visibility and easier access for participants; (3) minimizing exclusion criteria to allow enrollment of participants with stable psychiatric comorbid conditions; (4) delaying the baseline visit from the eligibility visit by a week to protect against attrition; and (5) regular and persistent calls to remind participants of upcoming appointments using cell phones and shelter-specific channels of communication.
Limitations The study’s limitations include generalizability due to the sample drawn from a single Midwestern city in the United States. Since inclusion criteria encompassed willingness to use NRT patch, all participants were motivated and were ready to quit smoking at the time of enrollment in the study. Findings from the self-select group will be generalizable only to those motivated and ready to quit smoking. High incentives may limit the degree to which the intervention is replicable.
Conclusions Lessons learned reflect the need to engage communities in the design and implementation of community-based clinical trials with vulnerable populations.
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