Grant Number:	1R21CA261233-01 Interpret this number
Primary Investigator:	Cioe, Patricia
Organization:	Brown University
Project Title:	Preloading with Nicotine Replacement Therapy in HIV-Positive Smokers to Improve Self-Efficacy and Quit Attempts
Fiscal Year:	2021

ABSTRACT Cigarette smoking is more prevalent in persons with HIV (PWH) in the U.S. when compared with the general population and is linked to increased morbidity and mortality in this population. Furthermore, HIV-positive smokers have increased rates of lung and other smoking-related cancers. Smokers with HIV are a particularly challenging group, often reporting high severity of nicotine dependence and low rates of self-efficacy for quitting, both factors related to poor smoking cessation outcomes. Establishing more effective smoking cessation approaches for smokers with HIV, particularly those that address low self-efficacy and severe dependence, is a public health priority. The overall goal of this research project is to examine the feasibility, acceptability, and preliminary efficacy of nicotine replacement therapy preloading (NRT-P) in HIV-positive smokers, who are struggling with cigarette dependence, urge to smoke (craving) and low self-efficacy as barriers to successful smoking cessation. Sixty participants will be recruited into a 12-week randomized pilot study. Thirty participants (control condition) will receive standard smoking cessation counseling (NRT-S) and will initiate an 8-week course of combination nicotine patch and lozenge on quit date (week 4), consistent with recommended guideline based on smoking rate. Thirty participants (active condition) will start NRT patch 3 weeks prior to quit date, followed by an 8-week course of combination nicotine patch and lozenge, initiated on quit date. We will examine dependence, urge to smoke and self-efficacy for quitting prior to and following quit date. We will also examine differences in quit attempts and biochemically validated smoking abstinence between the control and active conditions at weeks 8 and 12. This study will be the first to examine the feasibility and initial efficacy of a novel intervention using NRT preloading to improve smoking cessation outcomes in PWH. Given the high prevalence of smoking and the significant morbidity associated with it in PWH, the development of effective strategies to reduce the risks related to smoking in this group is critical. If determined to be effective, this intervention could be readily disseminated in HIV clinics. Our study will provide key information on the potential benefit of NRT preloading in a population that is highly dependent on nicotine and highly vulnerable to smoking-related morbidity and mortality. The results from this project will provide the foundation for a future R01 application to the National Cancer Institute to conduct a full-scale randomized clinical trial.





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