Clinical Research Directory

Clinical Alternatives for Reducing Harm Using E-cigarettes

For patients in cancer care, quitting smoking is critical, but a significant portion of patients in cancer care refuse all components of tobacco treatment, even when offered free of charge. The proposed clinical trial will assess one harm reduction intervention, switching completely from cigarettes to e-cigarettes, among oncology outpatients who smoke and refuse traditional tobacco treatment. This study is a type 1 hybrid effectiveness-implementation trial among oncology outpatients at an NCI-designated cancer center who smoke and refuse all components of tobacco treatment (N=208).

Using Smartwatches to Monitor Smoking in Real-life Situations

Background: It is important to quickly identify when people are at risk of smoking. Most current methods rely on people reporting when they smoke or what makes them want to smoke. But this can be hard for people to do and may not always be accurate. Other methods use special gadgets to identify smoking movements, but these may not always work well in real life. We want to see if we can use devices available on the market such as smartwatches to identify signs in the body and hand movements that might indicate when someone is about to smoke, is currently smoking, or has just smoked. Objective: To record body signs and hand movements before, during, and after smoking in real-life and in a lab to see how they change when someone is craving cigarettes, while a person is smoking, and after a person has smoked. Eligibility: People who are 21 years or older and smoke, have no college degree or be currently enrolled in college, and are low-income earners. To participate in the study, participants have to pass a breath test that shows they smoke cigarettes and, for women, a urine test to show that they are not currently pregnant. Design: Participants will complete an eligibility survey to see if they qualify to be in the study. If they qualify, they will answer a brief baseline survey that includes questions about themselves, their health, and their smoking behavior. Participants will get a smartwatch to wear for 3 days at home, log each time they are about to smoke and have finished smoking, and answer a 5-question health survey via the app. They will get instructions on how to set up and wear the smartwatch. They will download a mobile application on their phone. The app will collect data from the smartwatch. Participants will then come to the lab but will be asked not to smoke or drink alcohol for at least 12 hours. They will have to take a breath test to show they have not smoked or had alcohol. They will also give a blood sample. In the lab, they will sit in a room where they will be hooked to devices that monitor their vitals such as heart rate and blood pressure for one hour. They will also wear a smartwatch on each hand. While they are in the smoking room, they will go through 3 different phases: (a) pre-smoking where they will be asked to stay seated for about 25 minutes, (b) smoking where they will be asked to smoke as many cigarettes of their choice as they want for about 10 to 15 minutes, (c) post-smoking where they will be asked to stay seated, not smoking, for about 25 minutes. They will answer a brief 10-minute health survey before and after the session. Participation will last for 3 days of home monitoring and 2 visits to the research clinic that last about 2 hours.

Pain and Smoking Study 2.0: A Randomized Clinical Trial of Smoking Cessation Among Veterans With Chronic Pain

PASS2 aims to expand upon the recently completed study (PASS intervention), which tested the telephone delivery of a cognitive behavioral intervention (CBI). This study will use nightly surveys to optimize the intervention's effectiveness for smoking cessation among Veteran smokers with chronic pain.

Negative Pressure Wound Therapy Devices in Total Knee Arthroplasty

This study is a single-center, prospective, randomized, open-label clinical trial evaluating three commercially available closed-incision negative pressure wound therapy (ciNPWT) devices: NPseal, PICO, and Prevena, in adult patients undergoing primary total knee arthroplasty (TKA) who meet predefined high-risk criteria for wound complications. A total of approximately 300 participants will be enrolled and randomized in a 1:1:1 fashion to receive one of the three study dressings applied over the closed surgical incision at the end of the procedure. All participants will otherwise receive standard perioperative and postoperative care. The primary follow-up period will extend through 90 days after surgery. The primary objective is to compare the incidence of 90-day surgical site complications, including superficial infection, wound dehiscence, seroma, and hematoma, across the three dressing groups. Secondary objectives include evaluation of device usability, patient experience, and device-related issues (such as loss of seal, alarms, tubing or pump problems, fluid saturation, and premature dressing changes), as well as assessment of the interaction between skin closure method and device performance. Research-specific activities are limited to eligibility confirmation, informed consent, randomization, administration of a brief postoperative patient survey at approximately postoperative day 7 and/or dressing removal, provider assessment of the dressing at removal, and collection of clinical outcomes from the medical record. No additional blood draws, imaging, or invasive procedures are required for participation. This study is designed to address a gap in the literature by providing head-to-head comparative data on commonly used ciNPWT systems in a high-risk primary TKA population, with the goal of informing postoperative wound management strategies in clinical practice.

A Study of Brenipatide in Adults Who Quit Smoking Cigarettes and Want to Avoid Relapse

This study evaluates the efficacy and safety of brenipatide when compared to placebo for reducing the risk of relapse to cigarette smoking in adults who have recently quit. Study participation will last approximately 34 weeks with up to 17 study visits, which includes a 2-week screening period, 24-week treatment period, 8-week safety follow-up period.

Actívatexto: Advancing Smoking Cessation and Physical Activity Among Latinos

The purpose of this randomized controlled trial is to assess the efficacy of Actívatexto (Aim 1) and the mediators of the presumed treatment effect (Aim 2) among Latino adults who smoke. Actívatexto is a mobile intervention that integrates four components: 1) a text messaging program that promotes both smoking cessation and physical activity, 2) wearable devices to monitor physical activity, 3) smoking cessation pharmacotherapy \[i.e., nicotine replacement therapies (NRT)\], and 4) an online dashboard where the research team manages participants' incoming and outgoing data from both the text messaging program and wearable devices.

Precision Prevention Strategy to Increase Uptake and Engagement in Lung Cancer Screening and Smoking Cessation Treatment

This trial tests the effects of two versions of RiskProfile, a clinically-informed and a genetically-informed version of a patient-specific risk feedback tool, in comparison to usual care, on lung cancer screening and tobacco treatment. The trial assesses the multilevel effects of these precision risk feedback tools on the likelihood of clinicians to order lung cancer screening and tobacco treatment and of their patients to utilize these cancer prevention interventions.

Enhancing Mental and Physical Health of Women Veterans

Women Veterans are the fastest growing segment of VA users. This dramatic growth has created challenges for VA to ensure that appropriate services are available to meet women Veterans' needs, and that they will want and be able to use those services. The EMPOWER QUERI 2.0 Program is a cluster randomized type 3 hybrid implementation-effectiveness trial testing two strategies designed to support implementation and sustainment of evidence-based practices for women Veterans in at least 20 VA facilities from 4 regions.

App for Reducing Cravings to Smoke

The overall goal of the study is to assess the efficacy of using cue exposure delivered via a smartphone application as an adjunct to Tobacco Quitline treatment to improve smoking abstinence.

Feasibility of Conducting a Pilot Telehealth Study Assessing the Removal of Filter Ventilation on Smoking Behavior and Biomarkers in Menthol Smokers Switched to Non-menthol Cigarettes

This decentralized clinical trial assesses the feasibility of conducting a tobacco product evaluation study remotely via telehealth visits and mailed samples. This is an open label, between-subject, randomized pilot study to assess the effect of minimal filter ventilation vs. moderate filter ventilation on smoking behavior and biomarkers of exposure (e.g. nicotine, carbon monoxide) in menthol smokers switched to non-menthol cigarettes. Subjective measures, alveolar carbon monoxide, blood pressure and cigarettes smoked per day will be collected remotely. Biological samples will be collected at home and mailed into the clinic.

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.

Reducing Tobacco-associated Lung Cancer Risk: A Randomized Clinical Trial of AB-free Kava

Tobacco use is the leading cause of many preventable diseases, particularly lung cancer. Based on the national cancer data in 2020, Florida has the highest lung cancer incidence (18,150 cases) with the most deaths (10,580 deaths) among all the states in the United States. Unfortunately, around 16% of adults in Florida continue to smoke cigarettes due to its addictive nature and the limited success of current cessation strategies. Therefore, there is an unmet and urgent need for novel interventions to improve the success of tobacco cessation. If such an intervention can reduce tobacco-associated lung carcinogenesis, that will be more desirable. The ultimate goal of this study is to develop a safe and effective kava-based intervention to enable tobacco cessation and reduce lung cancer risk, which will improve the health of Floridians. This study will evaluate the compliance with a daily kava regimen among active smokers who have no intention to quit smoking. This study will also investigate whether kava use can reduce tobacco use and dependence, as well as tobacco-associated lung carcinogenesis.

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.

Functional Capacity, Subjective Dyspnea and Fatigue in Smokers

Smoking remains a significant public health problem among the young adult population. Epidemiological studies in Turkey show a steadily decreasing age of smoking initiation and a remarkably high rate of smoking among university-aged individuals. Exposure to secondhand smoke is known to have negative effects on the respiratory system, cardiovascular system, and peripheral muscle function. Impaired lung ventilation, reduced gas exchange, and insufficient oxygen transport due to smoking can lead to decreased exercise tolerance, premature fatigue, and increased perception of exertional dyspnea. These effects can manifest as a decrease in functional capacity even before the development of a clinically significant respiratory disease. Functional capacity is an important indicator reflecting an individual's ability to perform daily living activities and is frequently assessed in clinical research using submaximal exercise tests. The 6-Minute Walk Test is a widely used, valid, and reliable test for assessing cardiorespiratory endurance and overall functional status. Similarly, the 1-Minute Sit-Stand Test is recommended as a practical and applicable method for evaluating lower extremity muscle endurance and functional performance. Dyspnea is a multidimensional symptom reflecting an individual's subjective perception of respiratory discomfort and is assessed using scales such as the Modified Medical Research Council and the Borg Dyspnea Scale. The Turkish Thoracic Society's dyspnea assessment reports indicate that exertional dyspnea may increase in smokers even if respiratory function tests are within normal limits. Fatigue, on the other hand, is a significant symptom that negatively affects an individual's daily living activities and physical functionality, arising from inflammatory processes, impaired oxygenation, and decreased physical activity levels associated with smoking. The Fatigue Severity Scale is a validated and reliable scale for assessing the impact of fatigue on an individual's physical and social life. While studies in the literature examine the effects of smoking on respiratory function and exercise capacity, studies that address the relationship between functional capacity and subjective dyspnea and fatigue in young adult smokers are limited. In particular, evaluating functional test results such as the 6-Minute Walk Test and the 1-Minute Sit-Stand Test together with dyspnea and fatigue perception will contribute to the early identification of subclinical functional effects. The aim of this study is to examine the relationships between functional capacity (6-Minute Walk Test, 1-Minute Sit-Stand Test, and Timed Up and Go Test) and subjective dyspnea (Modified Medical Research Council Scale - mMRC) and fatigue level (Fatigue Severity Scale) in young adult smokers aged 18-30 years. The findings of this study are expected to draw attention to the functional effects of smoking in young adults, contribute to the development of preventive health approaches, and facilitate the planning of physiotherapy-based assessment and intervention programs.

Improving the Reach & Effectiveness of Smoking Cessation Services Targeted to Veterans Living With HIV

This project will compare the effectiveness of an HIV-specific comprehensive wellness intervention designed to have broad appeal to smokers living with HIV to the effectiveness of standard care services that include referral to the National VA Quitline and SmokefreeVET texting program. Participants in both arms will have access to pharmacotherapy available through their Veterans Affairs (VA) healthcare providers.

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.

Racial Differences in Circadian and Sleep Mechanisms for Nicotine Dependence, Craving, and Withdrawal

The number one preventable cause of death in the world is tobacco use. Cigarette smoking in particular, costs an estimated $300 billion due to expenses related to medical care and lost productivity. Despite similar smoking prevalence rates, blacks suffer disproportionately from smoking-related harms compared to whites.Sleep disparities such as shortened sleep duration, shorter circadian periodicity, earlier chronotype, and increased variability of sleep timing have been reported more frequently in blacks compared to whites. Given that poor sleep quality predicts relapse from smoking cessation programs, particularly among socioeconomically disadvantaged adults, sleep deficiencies and irregular timing of sleep may impact smoking craving and withdrawal symptoms over the course of the 24-hour day. Surprisingly, few studies have examined these temporal patterns of smoking and craving, and none with regard to sleep disruption, chronotype or racial disparities. A better understanding of these factors may explain heterogeneity within the smoking population, especially in minorities. Thus, the purpose of this proposal is to test the central hypothesis that the impact of chronotype and impaired sleep on cigarette usage as well as smoking dependence, urge/craving, and withdrawal depends on race.

A Patient-Oriented Research Mentoring Program in Tobacco Dependence and Implementation Science Research

The objective of this trial is to evaluate the effectiveness of "nudges" to clinicians, patients, or both in increasing referral to, and engagement with, tobacco use treatment services (TUTS) for HIV patients versus usual care. This will be a four-arm pragmatic cluster randomized clinical trial. The investigators hypothesize that each of the implementation strategy arms will significantly increase TUTS referral and engagement compared to usual care and that the combination of nudges to clinicians and to patients will be the most effective.

Smartphone-delivered Scheduled Smoking With Compliance Facilitation as an Adjunct Cessation Therapy: a Feasibility Study

To collect user experience data for a smartphone app that is designed to help people reduce or quit smoking and to learn if the app, combined with nicotine patches, can help people quit smoking.

Refer2Quit: Evaluating a Proactive, Tailored, Population Health Approach for Tobacco Treatment for Household Smokers Through a Pediatric Care Network

The goal of this clinical trial is to compare the reach and effectiveness of the Refer2Quit intervention for increasing tobacco use treatment and quit rates among household members who smoke versus a treatment as usual group. This clinical trial also aims to study household member and pediatric patient characteristics that are associated with reach and effectiveness of Refer2Quit.

Personalized Tobacco Treatment in Primary Care (MOTIVATE)

This study examines the application of precision treatment intervention for smoking cessation from both the clinician perspective and patient perspective, and compares it to usual care on tobacco treatment in the primary care setting. The precision treatment intervention includes personalized tobacco treatment recommendations using the patient's clinical, genetic, and biomarker information. This approach may increase effectiveness and adherence for the patient, and increase the clinician's likelihood of prescribing.

Assessment of HPHC Exposure in Smokers Switching to THS/TP18 With Different Device Variants

This is a randomized, controlled, open-label, 6 parallel arms study to assess reduced exposure of biomarkers of exposure (BoE) of selected HPHC in smokers switching to TP18 (a prototype heated tobacco device) or THS relative to smokers who continue smoking CIG after 5 days of confinement period, followed by 2 days of pharmacokinetic (PK) period of single use of THS/TP18 and CIG, and followed by an ambulatory period.

Precision Treatment to Promote Smoking Cessation and Survival in Oncology Patients

This study evaluates the feasibility and preliminary effects of precision tobacco treatment, compared to usual care, on promoting tobacco treatment in oncology patients and providers in the oncology care setting. The precision treatment intervention includes personalized tobacco treatment recommendations using the patient's clinical, genetic, and biomarker information. This intervention may increase patient receipt of tobacco treatment, patient medication use, and patient smoking abstinence at 6 months.

Project DEDUCE: Digital Envirotyping to Develop Understanding of Cigarette Smoking and the Environment

Tobacco use is a chronic relapsing condition. That is, even with state-of-the-art treatment, \>70% of smoking cessation attempts end in a return to regular smoking. Research demonstrates that everyday environments associated with smoking trigger craving for cigarettes, provoke smoking, and lead to relapse. However, despite this knowledge, understanding of environmental correlates of smoking has been limited by a reliance on self-report, leading to imprecise information about the physical environments in which people live. To overcome this challenge, the research team has pioneered the development of digital envirotyping, which uses digital tools (e.g., sensors, cameras, artificial intelligence) to efficiently and accurately characterize and categorize environments with the goal of identifying environmental markers of behavior and health. Foundational to the digital envirotyping research is computer vision (CV), a type of artificial intelligence (AI) that enables computer systems to recognize objects and scenes in digital images, mimicking how humans perceive and understand visual information. With CV researchers can extract detailed and accurate information (i.e., objects and location types) about the everyday environments of people who smoke (PWS) and relate that information to smoking behavior. After validating the use of CV, the researchers used CV to develop enviromarkers of relapse risk. Importantly, they identified a novel enviromarker in which people at greater risk for relapse when they quit are exposed to a more consistent level of environment-related smoking risk as they move between their smoking and nonsmoking environments. Research is now needed to advance digital envirotyping and enviromarker development in the field of tobacco addiction. The study will recruit a diverse, national sample of n=500 adults who are interested in quitting smoking. For two weeks prior to quitting, they will undergo photoEMA in which they will take two pictures of their current environment when they smoke, and randomly 10 times per day resulting in \>300,000 images total. Cessation will be supported by nicotine replacement therapy (i.e., nicotine patch). The primary clinical outcome will be days to relapse. Specific aims are to (1) further develop, refine, and validate methods for efficient digital envirotyping at scale, (2) leverage CV and AI approaches to develop enviromarkers of smoking relapse, and (3) conduct analyses to increase understanding of environmental smoking risk in women and individuals with low socioeconomic status.