Clinical Research Directory

Adaptation and Testing of a Novel Text-based Tobacco Cessation and Education Intervention in Kenyan Emergency Department Patients

In this study, investigators will adapt and implement Text2Quit in a Kenyan ED population will increase knowledge and cessation. Investigators will use a mixed-methods, hybrid implementation-effectiveness approach to assess these outcomes. Results will inform a randomized, controlled trial in a nationally representative sample of EDs in future. This study will be the first to target tobacco use in this population, the first to use mobile cessation, and will contribute to advancing implementation science on tobacco cessation globally. It will also provide a novel approach to implementation for mHealth interventions, with findings that can be generalized to other Non-Communicable Diseases and risk factors, such as alcohol use, hypertension and diabetes.

Developing a Scalable Tobacco Cessation Program for Cancer Survivors and Caregivers

Given the challenges to delivering tobacco cessation treatment in oncology care and the unique challenges faced by individuals attempting to quit tobacco after a cancer diagnosis, scalable cessation programs that are tailored to the experiences of cancer survivors that also integrate caregiver/family support are needed. To address this need, this study will use an intervention that consists of two primary strategies: 1) a tailored cessation program for cancer survivors and family members/caregivers who use tobacco and 2) healthcare provider training. Healthcare providers will receive training on the AAC model (Ask patients about tobacco use, Advise patients to quit, Connect patients to cessation resources), including materials focused on tobacco cessation in cancer care from the CDC, as well as a brief evidence-based communication skills training based on the C-LEAR (Counsel, Listen, Empathize, Answer, Recommend) approach.

Smoking Cessation in Patients With Cancer

This randomized controlled trial will evaluate whether adding one-session structured cognitive behavioral therapy (CBT)-based smoking-cessation counseling to standardized brief smoking-cessation counseling improves cigarette smoking abstinence among patients with cancer who smoked combustible cigarettes at diagnosis and are still smoking at screening and enrollment. After written informed consent and baseline assessment, all participants will receive the same standardized brief smoking-cessation counseling using a condensed 5A framework. Participants will then be randomly assigned 1:1 to no additional study CBT or to one additional structured CBT-based smoking-cessation session. Follow-up will continue for 3 months after randomization at Campus 3 of Vietnam National Cancer Hospital in Hanoi, Vietnam.

STEPS: Substance Use Trial of E-cigarettes or Pharmacotherapy for Smoking

The purpose of this study is to investigate whether non-cigarette tobacco products, namely e-cigarettes (nicotine vapes), can help people who smoke and are in treatment for substance use disorder quit smoking by switching completely to e-cigarettes as compared to FDA-approved medications, namely nicotine replacement therapy in the form of patches and lozenges. Participation will last 6 months and includes 14 weekly study visits and 2 follow-up study visits (in-person, but virtual study visits are possible). Participants will also complete a short daily diary on their phones each day for the first twelve weeks. To qualify, participants (ages 21+) must be enrolled in an outpatient substance use disorder (SUD) treatment program. The study is being done in four regions across South Carolina: Charleston, Pickens/Easley, Conway, and Greenville.

Automating Tobacco Cessation in Primary Care

This study focuses on improving how primary care teams identify patients who smoke and offer access to nicotine replacement therapy, or NRT. NRT includes medications such as nicotine patches, gum, or lozenges that can reduce cravings and support people who are interested in cutting back or quitting smoking. Although NRT is an evidence-based treatment option, it is not always discussed or prescribed during routine primary care visits. To better understand how NRT can be offered in primary care, the project will test a workflow at Penn Family Care that identifies patients who currently smoke and provides information about available tobacco treatment options. Edward Cooper Internal Medicine will serve as a comparison site. Patients who smoke and/or are prescribed NRT will also receive a 30-day follow-up survey to learn whether they received, picked up, or used NRT; whether it was useful; and what barriers they experienced.

Smoking Relapse Prevention in Patients With Cancer

This randomized controlled trial will evaluate whether adding one-session structured cognitive behavioral therapy (CBT)-based relapse-prevention counseling to standardized brief relapse-prevention counseling improves smoking abstinence among patients with cancer who smoked cigarettes at diagnosis and have remained completely abstinent from diagnosis until enrollment. After written consent and baseline assessment, all participants will receive the same standardized brief relapse-prevention counseling. Participants will then be randomly assigned 1:1 to no additional study CBT or to one additional structured CBT-based relapse-prevention session. Follow-up will continue for 3 months after randomization at Campus 3 of Vietnam National Cancer Hospital in Hanoi, Vietnam.

A Study to Assess Nicotine Uptake From a Menthol Electronic Nicotine Delivery System Product

This will be a randomized, open-label, 2-way crossover, single-site study designed to evaluate elements of abuse liability (AL), including subjective effects and physiological measures (pharmacodynamics \[PD\]), and plasma nicotine uptake (pharmacokinetics \[PK\]) of Menthol ENDS investigational product (IP) relative to each participant's usual brand (UB) menthol cigarette. The study will be conducted in a confinement setting in generally healthy adult menthol cigarette smokers and dual users of menthol cigarettes and ENDS products.

Quit With Sense: Using Mindful Smoking and Wearable Device for Smoking Cessation

This pilot randomized controlled trial will test the feasibility of a smoking cessation intervention using mindful smoking practice and a smartphone-based sensor-band among adults who regularly smoke cigarettes. Participants will be randomized to either an intervention group or a control group. Participants in the intervention group will receive a one-on-one mindful smoking guidance session, instructions for using a smartphone-based sensor-band, a mindfulness practice video, and smoking cessation information. Participants in the control group will receive smoking cessation information. The intervention period will last 8 weeks, with assessments at baseline, 8 weeks, and 4 months after completion of the intervention. The study will evaluate feasibility, preliminary smoking cessation outcomes, and physiologic parameters including heart rate variation, skin temperature, resting heart rate, respiratory rate, and real-time heart rate during craving and mindful smoking practice.

Modeling Tobacco Regulatory Impacts in Appalachia Using the Experimental Tobacco Marketplace

The goal of this project is to look at the effect of proposed tobacco product regulations in Appalachian Kentucky. Appalachian Kentucky is a diverse and underserved rural area that would benefit from more tobacco regulation research. Researchers will study the effects of three proposed tobacco product regulations among users of tobacco products in Appalachian KY. Researchers will also study how degree of rurality effects how those regulations impact behavior. Participants will be asked to complete online surveys and tests, online shopping sessions in a simulated Experimental Tobacco Marketplace, and track their tobacco product use throughout the 4-week experiment.

Development of UP2UTeacher for High School Youth

Tobacco use is increasing among youth in the U.S. However evidence for the long-term effectiveness of tobacco prevention and cessation programs for youth is limited. The current study seeks to adapt and evaluate a universal group-based youth brief tobacco intervention for 9th grade students. This study will use a sequential, multi-method research design beginning with qualitative roundtable discussions with 9th grade students to adapt an existing young adult brief tobacco intervention for youth. Roundtable discussions with students will identify salient intervention themes and strategies for targeting the intervention and developing the text messages. The second phase of the study evaluates the brief intervention, UP2UTeacher, through a cluster randomized controlled trial that compares UP2UTeacher to a no treatment control. It is hypothesized that the UP2UTeacher will reduce tobacco use at the 12-month follow-up compared to the no treatment control. Roughly 90% of daily smokers started before the age of 18, and 2,000 youth smoke a cigarette for the first time each day in the U.S. Additionally, e-cigarette use is on the rise among youth, and is linked to cigarette initiation among tobacco naïve youth. In order to curb the rise of tobacco use among youth, interventions that are easily implemented and easily disseminated need to be developed for youth addressing currently available products and contemporary patterns of use. If the interventions in the current study are proven efficacious, they can easily be disseminated to other schools to continue reducing youth tobacco use.

Evaluation of Effectiveness of the LifeSkills Training - Lombardia - Primary Shool Program ( Val3P-LST )

Life Skills Training is a school-based prevention program aiming at promoting wellbeing and at preventig use of substances. It has a version for middle school and another for primary school students. The LST-Primary has been evaluated evaluated in US with partially positive results. Regione Lombardia decided to translate and adapt the LST-Primary program for the Italian population. In a first time, involving the US developers, the program has been translated and adapted to Italian students. The present study is aimed at evaluating the effectiveness of the program adopting an experimental design and a random allocation of the condition.

The ICEC Cluster Trial: Integrated Community Engagement Collaborative for Youth Substance Use Prevention in Rural America

This study will evaluate whether the Integrated Community Engagement (ICE) Collaborative can help prevent alcohol, tobacco, and other drug use among youth living in rural communities. The study is coordinated through the West Virginia University Prevention Research Center and will be conducted in participating public schools and County Prevention Coalitions located in up to 36 rural counties in West Virginia. Students in grades 7 through 12 at participating public schools will complete confidential online surveys once each year for four years. The surveys will assess alcohol, tobacco, and other drug use, as well as family, peer, school, and community factors that may increase or decrease the risk of substance use. All participating counties will receive reports summarizing these survey results at the school and county levels. Counties will be randomly assigned to one of two groups. Counties in the intervention group will receive support from trained Network Coordinators who will work with local County Prevention Coalitions to review community data, engage local stakeholders, develop action plans, strengthen prevention efforts, and support implementation of community-selected prevention strategies. Counties in the comparison group will receive survey reports but will not receive this implementation support. The researchers will compare the two groups to determine whether the ICE Collaborative reduces youth alcohol, tobacco, and other drug use and improves community factors that support healthy youth development. The study will also evaluate whether the intervention strengthens community prevention coalitions, stakeholder engagement, resource development, and implementation of prevention programs and policies

A Community Health Intervention to Improve Lung Cancer Screening Uptake in Community Health Centers

Lung cancer screening (LCS) can reduce lung cancer-related mortality, but screening uptake remains low among eligible individuals. The goal of this study is to partner with community stakeholders to develop and pilot test a multi-component navigator-delivered intervention targeting key barriers to lung cancer screening and tobacco treatment utilization. Participants are randomized to enhanced usual care, a community health worker (CHW)-delivered intervention, or the same intervention delivered by a trained lay navigator. The intervention includes patient outreach, patient-centered shared decision-making, tobacco treatment counseling, and assistance navigating logistical barriers to care. The proposed activities will lay the groundwork for a subsequent fully powered randomized clinical trial evaluating CHW- and lay navigator-delivered approaches to facilitate access to lung cancer screening and tobacco treatment.

Impact of Electronic Cigarette Temperature and Solvent on Biomarkers

This project seeks to determine how e-cigarette (EC) physical design features, including those that allow the user to manipulate the quality and quantity of aerosols, affect exposure and toxicity from oxidants and other aerosol constituents.

Salvation Army Tobacco Quit Line Referral Implementation Trial

The goal of this clinical trial is to understand how the Salvation Army staff can help people who use tobacco learn about and connect with no-cost treatments to help cut down or quit smoking. Researchers will gather information about the thoughts and experiences of people who smoke tobacco and receive services at the Salvation Army, as well as the experiences of the staff offering support to help treat tobacco use.

Overcoming Nicotine Dependence to Enable Quitting

Tobacco use disorder is a chronic, relapsing health condition that necessitates a chronic care approach. However, traditional smoking cessation treatment programs allocate nearly all their resources only to those smokers who are willing to set a quit date. This is problematic because few smokers are ready to set a quit date at any given time, and a smoker's stated intention to quit can change rapidly. One novel potential treatment strategy is to foster practice quitting (PQ), defined as attempting to not smoke for a few hours or days, without pressure or expectation to permanently quit. Although a growing body of evidence supports the role of practice quitting in fostering permanent quit attempts and cessation, there is a significant knowledge gap regarding which treatment strategies should be used to engage smokers in practice quitting. The proposed study will test the role of PQ counseling vs. Motivational Interviewing (MI) counseling, and NRT sampling (four-week supply of nicotine lozenges and patches) vs. none.

Reducing Tobacco Exposures Among African American Women and Children

Secondhand smoke exposure in the home can causes sudden infant death syndrome (SIDS), asthma, respiratory illnesses, and ear infections in children. In addition to cigarette smoke, exposure to other tobacco products can further compromise the safety of children in the home. This study aims to reduce the burden of multiple tobacco exposures, improve access to preventive care, and reduce the disproportionate risk for chronic diseases, including cancer, among African American women and children living in the Arkansas Delta region. Our central hypothesis is that messages delivered by a community health worker that aim to modify knowledge, attitudes, beliefs, and subjective norms may influence the perceived threat of tobacco exposures and provide cues for African American women caregivers to implement comprehensive smokefree policies to protect their children from the harms of tobacco and in-turn, influence their quitting.

Strategies to Connect Patients at Federally Qualified Health Clinics With Evidence Based Tobacco Cessation Treatment

This trial aims to connect tobacco using patients of Community Health Centers (CHCs) and Federally Qualified Health Centers (FQHCs) with evidence-based treatment to help them quit. The trial will evaluate multiple strategies, that target both clinics and for patients, to increase the number of patients who enroll in Utah Tobacco Quit Line treatment.

Teachable Moment to Opt-out of Tobacco: Interactive Voice Response Quit Line for Veteran Active Smokers With Lung Nodules

The purpose of this study is to evaluate the effectiveness of a smoking cessation outreach intervention (TeaM OUT) on increasing use of smoking cessation resources in Veterans. The hypotheses are 1) patients included in the TeaM OUT group will have higher accession of cessation services, such as counseling and medication therapies, compared to patients in enhanced usual care and 2) more patients in the TeaM OUT group will have quit smoking at one year after the intervention. Veterans with a recently diagnosed lung nodule who currently smoke will receive the TeaM OUT intervention or Enhanced Usual Care. The TeaM OUT intervention has 2 parts: 1) a letter that a) describes the nodule and the importance of cessation related to the pulmonary nodule (i.e. teachable moment) and b) notification that a Proactive IVR Quit Line will initiate contact and 2) call(s) from the Proactive IVR Quit Line which a) offers smoking cessation resources and b) helps connect the patient to those resources. The enhanced usual care group will receive a letter that provides information about how to contact the IVR Quit Line. The IVR system will track referrals to cessation services. Additional information about smoking status and use of cessation resources will be collected from the electronic health record and surveys.

Influence of Tobacco Use on Cannabis Use

Cannabis smokers who also smoke tobacco cigarettes have markedly higher rates of cannabis relapse relative to those who do not use tobacco. There is a clear need to develop and evaluate interventions for dual tobacco and cannabis users. The investigators of this study have previously shown that the co-use of tobacco cigarettes contributes to the maintenance of daily cannabis use, and that age of cigarette onset is a critical predictor of treatment outcome. Short-term tobacco cessation may suffice in altering cannabis relapse rates in later-onset cigarette smokers, while a longer period of tobacco cessation may be needed for earlier-onset smokers. In the current study, a human laboratory model will be utilized to determine whether cannabis relapse varies as a function of tobacco cessation duration and age of tobacco use onset.

Responses of Adults Smoking Nondaily and Daily in the Experimental Tobacco Marketplace

The goal of this project is to learn about the potential impact of tobacco regulations that could affect the availability of tobacco products among adults who smoke nondaily and daily. Nondaily smoking is increasingly common and tobacco regulation research should consider how FDA actions may impact this group. Participants will be asked to complete online surveys and tests, online shopping sessions in a simulated Experimental Tobacco Marketplace. Reactions and decisions of adults who smoke nondaily and daily will be compared.

Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS

The purpose of this randomized study is to demonstrate direct clinical benefit, i.e., observed benefits in how humans with COPD feel in terms of symptoms (e.g., cough frequency, shortness of breath, and other respiratory symptoms) and function (e.g., lung function, and six-minute walking test \[6MWT\]) after switching to THS compared to continuing to smoking cigarettes.

Cardiovascular Effects of Very Low Nicotine Content Cigarettes

The study is measuring Cardiovascular effects of very low nicotine content cigarettes on daily and non-daily smokers

A Study Evaluating the Use of an Indoor Air Quality Monitor to Promote a Smoke-free Home

The purpose of this study is to evaluate how using an indoor air quality monitor can promote a smoke-free home for cancer patients who are enrolled in MSK's Tobacco Treatment Program.