Clinical Research Directory

Effects of E-cigs vs Pouches on Cigarette Smoking and Addiction

The study will recruit an anticipated 256 adults who currently smoke cigarettes and report a willingness to try switching to alternative, non-combustible products. Participants will be randomized to receive either e-cigarettes or nicotine pouches for a duration of 4 weeks and to 1 of 4 possible regulatory scenarios within products where flavor availability is either menthol and tobacco/unflavored available or tobacco/unflavored only available, and nicotine concentration is either higher (5% e-cig, 6mg pouch) or lower (2.4% e-cig, 3mg pouch). Participants will return for bi-weekly research visits (in person or remote videocall) to complete measures for study aims. Participants will complete a final follow-up at Week 6 to assess maintenance of cigarette reduction and willingness to continue using products once they are no longer provided. The investigators expect to observe which products and constituents lead to greater smoking reduction.

Nordic Spirit Pouch Nicotine Pharmacokinetics Abuse Liability

Nicotine pharmacokinetics and subjective effects of 9 Nordic Spirit Nicotine Pouch Products in adult cigarette smokers: A controlled, randomized, cross-over study with a balanced incomplete block design.

ACT Lung Health Intervention: Phase Two

This study aims to test a counseling and educational program designed to improve lung health through smoking cessation for Chinese and Korean American smokers at high risk for lung cancer.

Evaluation of a Novel mHealth Intervention for People Who Are Ambivalent About Quitting Smoking: A Randomized Controlled Trial

The goal of this study is to compare the effectiveness of two smoking cessation programs to determine which better helps people change their smoking behavior, the control or the experimental intervention? Both interventions include access to a mHealth app and other publicly available stop-smoking resources. The two app versions each include best practice advice and guidance for quitting smoking, but one includes additional content designed for people who aren't ready to quit smoking. We hypothesize that people who receive the experimental intervention will be more likely to request additional stop-smoking resources offered through the intervention and report smoking abstinence after 6 months. We also hypothesize people assigned to the experimental app will have better app engagement and be more likely to report positive changes in their smoking behavior and use of other evidence-based stop smoking treatments that are publicly available.

A Clinical Trial of Adaptive Treatment for Early Smoking Cessation Relapse

This is a research study to find out if treatment decision making can be improved for smokers who find it difficult to quit with medications. Everyone who participates in this study will receive free product, either nicotine replacement therapies (patches and lozenges), varenicline, or a harm reduction product (e-cigarette) for a full 12 weeks. Most participants will receive some combination of these treatments, depending on individual response to each. All visits and study assessments will be entirely remote. All treatments will be provided free of charge for the first 12 weeks. After that, the study team will contact the participants 6 months after the first study phone call to complete another survey. The study lasts six months and will involve 8 surveys.

Impact of Lifestyle on Health Maintenance: A Randomized Controlled Trial

This study aims to evaluate the impact of public health interventions on changes in healthy lifestyle habits over time and their subsequent effects on health outcomes. The investigators hypothesize that exposing at-risk populations to structured physical activity programs, education on healthy nutrition, promotion of the Mediterranean diet, and workshops focused on strengthening psychological resilience will lead to improvements in anthropometric, oxidative, metabolic, and psychological parameters. Anthropometric and laboratory measures will be collected at multiple time points throughout the study. The longitudinal follow-up will span 12 months. It is anticipated that sustained adherence to healthy lifestyle behaviors will result in positive lifestyle changes and enhanced health-related quality of life.

Take A Break - Rural

The study team proposes a multi-level trial to test 1) novel implementation programs in rural counties designed to increase access to 2) recent advances in tobacco control services for people who are not-yet-ready-to-quit smoking. In this field, most trials have focused only on those already ready-to-quit. Thus, the proposed trial addresses an important knowledge gap critical to advance tobacco control in rural areas.

An Experimental Evaluation of Menthol-Flavored Tobacco Accessories

In a within-subjects design in-laboratory study, participants will sample non-menthol cigarettes mentholated with various accessories (e.g., crush balls, filter tips, aroma cards) in a controlled setting. They will compare these to their preferred menthol brand using subjective ratings (e.g., liking, strength, ease of use) and complete purchase tasks and ETM trials to assess product demand and likelihood of future use.

Vape Use Among Younger & Older Smokers

The study aims to recruit 100 current cigarette smokers (50 young adults ages 21-34; 50 older adults ages 35-65) who have tried vaping or are currently vaping (dual users). The study will examine the trajectories in tobacco use (cigarettes and/or ENDS), including the nuanced differences in ENDS use (i.e., detailed device characteristics, user preferences, patterns of use), according to smoker age group.

An Interactive Smartphone Application to Motivate Smokers to Quit

Prospective, randomized, single-blinded, blinded-endpoint trial to determine the impact of a smartphone application-based program to motivate smokers to increase readiness to quit, make quit attempts, and quit smoking.

Smoke Free SafeCare: Establishing a Smoke Free Home in CPS-involved Families

Smoke Free SafeCare (SFSC) is a proposed braided intervention consisting of two evidence-based interventions: Some Things are Better Outside (STBO), aimed at promoting smoke free home rules, and SafeCare, aimed at reducing child maltreatment and improving mother and child outcomes. STBO is effective in creating smoke free homes and reducing second-hand smoke in low-SES (socioeconomic status) households. SafeCare is an effective parent training program that is broadly disseminated in child protective services in the United States. SafeCare is a promising mechanism to effectively increase the reach of STBO to reduce SHS (secondhand smoke) exposure in families with documented high rates of tobacco use and children with cumulative risk for negative health outcomes.

Smoking Cessation Before Bronchoscopy or CT-guided Puncture

Nicotine is the most common preventable cause of death and is responsible for over seven million deaths worldwide. If current trends continue, tobacco will kill more than eight million people worldwide every year by 2030. Smoking tobacco products is the most important risk factor for the development of lung cancer. Passive smoking is also a major cause of lung cancer. Since July 2024, smokers and former smokers have been able to receive a low-radiation CT scan under certain conditions to detect lung cancer at an early stage. It is therefore to be expected that the number of diagnoses of pulmonary lesions or nodules will increase in the near future. The risk of developing and dying from tobacco-related diseases is reduced once nicotine cessation begins. Screening all patients for tobacco use, e-cigarette use, and providing behavioral counseling and pharmacotherapy to quit smoking are among the most valuable preventive services we can offer in healthcare. Nicotine dependence can be estimated using the so-called Fagerström test. An additional evaluation of nicotine behavior can be carried out by testing cotinine in urine, a method that is used, for example, in the listing for lung transplantation. Cotinine is a degradation product of nicotine that can be detected in the urine of smokers and passive smokers. Cotinine levels in urine depend on the frequency and quantity of nicotine consumption. The half-life of cotinine is 16 to 22 hours, which means that half of the cotinine is excreted from the body after this time. Another marker that can be used as a measure of tobacco consumption is carboxyhaemoglobin (COHb). This is hemoglobin with carbon monoxide at the binding site for oxygen. The reference range for carboxyhaemoglobin is 0.4 - 1.6 %. In smokers, values of 3-10 % are still considered normal. In our department, the smoking status of patients is assessed upon first contact. Support options for smoking cessation are offered and, upon request, initiated. Previous studies have shown that smoking is a risk factor for complications after thoracic surgical procedures and that patients who underwent thoracic surgery quit smoking almost twice as often compared to patients who did not undergo surgery. However, to the best of our knowledge, there is currently no study regarding smoking cessation before intervention in patients with nodules needing clarification (bronchoscopy or CT-guided puncture). Therefore, the aim of the study is to support and monitor smoking cessation before intervention in patients with nodules needing further diagnosis (bronchoscopy or CT-guided puncture).

A Study to Assess Nicotine Uptake From Electronic Nicotine Delivery Systems

This will be an open-label, randomized, single-site, 8-way crossover study designed to evaluate plasma nicotine pharmacokinetic (PK) parameters and overall product liking (OPL) following an ad libitum use of Electronic Nicotine Delivery System (ENDS) investigational products (IPs) in a confinement setting by generally healthy adult combustible cigarette smokers and smokers who also use ENDS products.

Abuse Liability for Eight Electronic Nicotine Products

This will be a randomized, open-label, 8-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 \[PK\]) during and following ad libitum use of Electronic Nicotine Delivery System (ENDS) investigational products (IPs) in a confinement setting by generally healthy adult smokers of combustible cigarettes and dual users of cigarettes and ENDS products.

Abuse Liability for Five Modern Oral Nicotine Products

This is a two-site, open-label, randomized, 4-way (2 arm) cross-over study designed to evaluate elements of abuse liability (AL) including subjective effects and physiological measures (pharmacodynamics \[PD\]) and plasma nicotine uptake (pharmacokinetics \[PK\]) during and following ad libitum use of the study investigational products (IPs) by generally healthy smokers

Digitally Enhanced Smoking Cessation for High Risk Smokers

This is a research study, is testing a program to improve lung health through smoking cessation and providing education around lung screening. In this research study involves Studying the Enhanced Smoking Cessation Approaches to Promote Empowerment (ESCAPE) program compared to usual care. The ESCAPE program was developed help women with HIV quit smoking. Women in the ESCAPE program quit smoking and stayed quit for longer (up to 3 months). For this study, investigators have added a lung screening to the ESCAPE program and want to test if this will improve lung health through increasing quit rates and lung screening. .

Abuse Liability for Four Heated Tobacco Product (HTP) Consumables and Two HTP Devices

This is a single-site, open-label, randomized, 8-way crossover study designed to evaluate elements of abuse liability (AL), including subjective effects and physiological measures (pharmacodynamics \[PD\]) and plasma nicotine uptake (pharmacokinetics \[PK\]), during and following ad libitum use of the study investigational products (IPs) by generally healthy adult smokers.

Influence of Authorized Smokeless Tobacco Product Modified Risk Claims I: Consumer Product Demand

To explore consumer responses to the announcement and implementation of new modified risk claims for Copenhagen and General Snus (brands of smokeless tobacco (ST) products) using a series of complementary and innovative research activities and methods.

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.

Health Opportunities and Promoters of Equitable Screening for Lung Cancer

The goal of this clinical trial is to promote lung cancer screening (LCS) uptake among Hispanic current and former smokers. The main questions it aims to answer are: * What barriers do current and former Hispanic smokers face in the identification and documentation of their smoking status? * How can digital delivery of an educational video promote LCS uptake among current and former Hispanic smokers? Participants will receive an educational video about lung cancer screening and complete brief, self-reported surveys afterwards.

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.

Switch or Quit R01

This study evaluates whether non-cigarette tobacco products (e-cigarettes) can help smokers quit smoking as compared to traditional quit methods (nicotine replacement therapy or varenicline/Chantix). Participants in this study will be randomly assigned to one of two groups, then will have a choice between the offered products of that group. Participants in the e-cigarette group will have a choice of e-cigarette brand and flavor. Participants in the medication group will have choice between nicotine replacement therapy (patches and lozenges) or varenicline, also known as Chantix. Participation will last 6 months and will include weekly phone calls for the initial 7-weeks plus a 11-week phone call and a 6-month follow-up visit. Participants will also complete electronic daily diaries during the first 7-weeks.

Impact of Smoking on Physical Activity Level in Young Adults

This study will aim to examine the relationship between the daily physical activity level and nicotine dependence severity in university students. By identifying whether a higher physical activity level is associated with lower levels of smoking, the findings will help inform interventions to support healthier lifestyles in young adults.

rTMS-concurrent Behavioral Priming for Reducing Smoking Cravings

The objective of this pilot clinical trial is to test the effects of different types of thinking strategies at the time of repetitive Transcranial Magnetic Stimulation (rTMS), applied to the left Dorsolateral Prefrontal Cortex (DLPFC), on smoking craving and brain activity. Participants will be individuals with moderate to high smoking dependence (smoking at least 8 cigarettes a day) who have no intention of quitting in the next 3 months and are eligible to have rTMS and functional magnetic resonance imaging (fMRI). The main objectives of the trial are: 1. To compare the craving-reducing effects of "upregulation" and "downregulation" of craving while looking at pictures related to cigarette smoking during rTMS versus no regulation of craving while looking at neutral pictures unrelated to smoking. 'Upregulation" is thinking about the immediate positive experience of smoking. "Downregulation" is thinking about the long-term negative consequences of smoking. 2. To examine changes in brain activity that accompany craving reductions produced by rTMS paired with upregulation and downregulation of craving while looking at pictures related to cigarette smoking versus no regulation of craving while looking at neutral pictures unrelated to smoking. Following screening for eligibility, participants will be trained on how to do upregulation and downregulation of craving. The participants will then participate in 3 testing sessions. In each session, the participants will receive rTMS at 20Hz in 50 trains (2000 pulses total), followed immediately by fMRI. Sessions will take place 1-2 weeks apart and will differ in the type of thinking strategy participants will use while looking at pictures during the rTMS: * upregulation of craving while viewing smoking-related images * downregulation of craving while viewing smoking-related images * no regulation of craving while viewing neutral smoking-unrelated images The order of sessions will be randomized across participants.