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 16-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 (or gum, based on
preference) on quit date (week 4), consistent with recommended guidelines 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 (or
gum, based on preference), initiated on quit date. The investigators will examine
dependence, urge to smoke and self-efficacy for quitting prior to and following quit
date. The investigators will also examine differences in quit attempts and biochemically
validated smoking abstinence between the control and active conditions at weeks 8, 12,
and 16.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04994444.
Locations matching your search criteria
United States
Rhode Island
Providence
Brown UniversityStatus: Active
Contact: Patricia Cioe
Phone: 401-863-6638
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. Dependence, urge to smoke and
self-efficacy for quitting prior to and following quit date will be examined. Differences
in quit attempts and biochemically validated smoking abstinence between the control and
active conditions at weeks 8 and 12 will also be examined. 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. This 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.
Lead OrganizationBrown University