Clinical Research Directory

Health Communications for Adults Smoking Nondaily

The goal of this study is to develop smoking health risk messaging targeted to adults who smoke some days, but not smoke every day (nondaily). The main purpose is to learn what type of smoking health risk messages will be most likely to encourage adults nondaily to quit completely. Aim 1will iteratively obtain qualitative feedback from adults smoking nondaily on initial message designs, resulting in 12 final messages. Aim 2 will test message properties using a 2 (health vs. social messages) x 2 (positive vs. negative messages) between subjects design to ascertain which messages promote proximal outcomes associated with quitting cigarettes (e.g., new knowledge, risk perceptions, motivation and intentions to quit).

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.

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.

Project HOPES: Healthy Options for Pain and Ending Smoking. A Program for Cancer Survivors.

The proposed pilot study will develop and test feasibility, acceptability, and signal for efficacy of a smoking cessation and pain management intervention for 20 cancer survivors.

Effectiveness of Oral Nicotine Pouches as a Cessation Tool Among Adult Tobacco Users in Pakistan

Smoking remains a major public health challenge in Pakistan, where many adult smokers have limited access to effective smoking cessation support. This randomized controlled trial aims to evaluate whether combining oral nicotine pouches (Velo® 6 mg) with structured motivational counselling is more effective than motivational counselling alone in helping adult smokers quit smoking. The study will enroll 148 adult smokers who smoke 10-14 cigarettes per day. Participants will be randomly assigned to one of two groups. One group will receive oral nicotine pouches together with motivational counselling, while the other group will receive motivational counselling only. The intervention will last for 12 weeks. The main questions this study aims to answer are: Does the combination of oral nicotine pouches and motivational counselling increase smoking cessation rates compared with motivational counselling alone? Does the intervention reduce cigarette cravings, withdrawal symptoms and the number of cigarettes smoked? Is the use of oral nicotine pouches safe, acceptable and well tolerated among adult smokers in Pakistan? How satisfied are participants with the treatment, and how well do they adhere to the intervention? Participants will: Be randomly assigned to receive either oral nicotine pouches plus motivational counselling or motivational counselling alone. Attend study visits at baseline and at weeks 2, 4, 8 and 12. Undergo carbon monoxide breath testing to verify smoking status. Complete questionnaires on cigarette cravings, withdrawal symptoms, treatment satisfaction and adherence. Report cigarette consumption and any side effects throughout the study. The findings from this trial will provide evidence on the effectiveness, safety, and acceptability of oral nicotine pouches as a smoking cessation aid for adult tobacco users in Pakistan and may help inform future tobacco harm reduction and smoking cessation strategies.

Smoking Cessation Program in the Construction Sector

The main objective of this study is to identify the optimal adaptive smoking cessation program for the construction sector in terms of effectiveness, cost-effectiveness, and potential implementation.

Virtual Reality (VR)and Mobile-Based Smoking Cessation in Breastfeeding Mothers

This randomized controlled trial was conducted to evaluate the effect of an educational video delivered through virtual reality (VR) glasses and a mobile application on smoking cessation behavior among breastfeeding mothers. The study was carried out in the breastfeeding outpatient clinic of a secondary-level public hospital. A total of 76 breastfeeding mothers with infants aged 0-6 months who reported active cigarette smoking were enrolled. Participants were randomly assigned to either an intervention group (n = 35) or a control group (n = 41) using a simple randomization method. Mothers in the intervention group viewed an educational video through VR glasses and a mobile application that provided evidence-based information on the harmful effects of smoking on maternal and infant health and encouraged smoking cessation. The control group received routine breastfeeding care and counseling provided by the clinic. Participants were followed for six months, with assessments performed at baseline and at the 1st, 2nd, 4th, and 6th months after the intervention. Data were collected using the Personal Information Form, the Fagerström Test for Nicotine Dependence, and the Questionnaire of Smoking Urges-Brief. The primary objective was to evaluate changes in nicotine dependence and smoking urges over the follow-up period and to determine the effectiveness of the VR- and mobile application-based educational intervention in supporting smoking cessation among breastfeeding mothers.

Evaluation of Low and High Nicotine Tobacco Free Nicotine Pouches

Tobacco-free oral nicotine pouches (such as Zyn brand) are a less harmful alternative to cigarette smoking. Pouches, however, contain nicotine, and addictive substance that is not risk-free. The present study is evaluating how well nicotine pouches, at different nicotine levels, help people switch away from smoking cigarettes. People who smoke cigarettes will be asked to answer questions about their tobacco product use and provide breath samples and cheek swab samples at an in-person visit to MUSC Charleston. Participants will then be provided with a 28-day supply of nicotine pouches, and will be asked to switch from smoking to pouches over the course of 4 weeks. Finally, participants will complete a final visit at MUSC, and will answer more questions about their tobacco use 1-month later.

A Study Of Vagal Nerve Stimulation In Conjunction With NRT For Smoking Cessation

The purpose of this study is to provide preliminary evidence for the efficacy of 12 weeks of vagal nerve stimulation (VNS) and nicotine replacement therapy (NRT) for increasing smoking abstinence rates.

Trial of Varenicline With Nicotine Lozenges and a Smartphone Medication Adherence Intervention for Smoking Cessation

No published studies to date have evaluated the combined impact of varenicline and oral nicotine replacement therapy (NRT) on smoking cessation in a randomized trial. Oral NRT, such as nicotine lozenges, can provide acute relief from cravings/withdrawal, and offers individuals the flexibility to deliver nicotine quickly, in contrast with the continuous, passive, and slow-acting delivery of the nicotine patch. Nevertheless, in clinical trials of other combination pharmacotherapies, participants' adherence to of oral NRT has been suboptimal, making it difficult to determine whether there is an added benefit. Given the near-ubiquity of smartphone ownership (85% of U.S. adults), it is plausible that smartphone-based medication adherence interventions could have a positive influence on pharmacotherapy adherence and smoking cessation. This investigative team has demonstrated the feasibility and potential efficacy of using combination varenicline plus oral NRT treatment to promote smoking cessation in a pilot factorial randomized trial. Likewise, pilot findings showed that medication adherence and smoking cessation rates were higher among those who received smartphone-based medication reminders than those who did not. The proposed study will enroll 496 adults who smoke cigarettes daily. The study will employ a 2x2 factorial design in which participants will be randomized to one of four combinations of two treatment factors: 1) pharmacological treatment (varenicline + nicotine lozenges vs. varenicline alone) and 2) smartphone medication adherence intervention (smartphone-based smoking cessation app with vs. without adherence components). The primary study outcomes will be biochemically-confirmed 7-day point prevalence abstinence at 26 weeks after a scheduled quit date, and medication adherence over the 13-week treatment period. Smartphone-based daily diaries will be employed to assess daily smoking and medication adherence. Notably, the proposed study will employ entirely remote assessment and treatment delivery strategies. Exploratory analyses will evaluate the potential interaction between medication type and the smartphone adherence intervention, and compare the influences of pharmacological treatment type and the medication adherence intervention on weekly physical symptoms (e.g., withdrawal, medication side effects). The overarching goal of the proposed research is to improve smoking cessation treatment and decrease cancer risk.

Concentration Impact Nicotine Salt

Double-blind (for the two active arms), randomized, three-arm (two active and one control) clinical trial investigating factors (e.g. nicotine concentration) influencing the success of smoking cessation strategies and possible health risks related to nicotine salt vaping.

Ending Tobacco Use Through Interactive Tailored Messaging for Cambodian People Living With HIV/AIDS

The goal of this research study is to test how well an automated text messaging smoking treatment program helps smokers with HIV quit smoking.

Evaluating the Impact of CONNECT in a Multilingual Population

This study aims to broaden the reach of the lung cancer screening (LCS) CONNECT program (NCT04149249, NCT06213532), by developing a version of the program to be available to multilingual communities. The CONNECT program encourages individuals who are undergoing lung cancer screening to also quit smoking by providing a personalized program which includes a video doctor with personalized responses, text message and telephone call support and connection with a pharmacist to assist in obtaining nicotine replacement medication. This clinical trial will develop and ultimately test how well the CONNECT Multilingual (CONNECT ML) program works to improve smoking cessation among current adult smokers within the Spanish and Cantonese speaking communities.

The Effect of Motivational Interviewing on Smoking Behavior Among Nursing Students

Smoking is one of the leading preventable public health problems worldwide, particularly among young adults who are at increased risk of nicotine dependence. Nursing students represent an important target population because, as future health professionals, they are expected to play a significant role in tobacco control and smoking cessation counseling. The Transtheoretical Model (TTM) is one of the most widely used theoretical frameworks for promoting health behavior change. The aim of this study will be to determine the effect of Transtheoretical Model-based motivational interviewing on changing smoking behavior among nursing students. This study will be planned as a single-group, quasi-experimental pretest-posttest intervention. Nursing students who smoke cigarettes and voluntarily agree to participate will be included in the study. At baseline, participants will complete a Demographic Information Form, the Fagerström Test for Nicotine Dependence, the Stages of Change questionnaire, the Self-Efficacy/Temptation Scale, the Processes of Change Scale, and the Decisional Balance Scale. Participants will receive Transtheoretical Model-based educational sessions and motivational interviewing interventions focusing on the health effects of smoking, reasons for smoking, the benefits of smoking cessation, identification of social support resources, relapse prevention strategies, and successful smoking cessation experiences. The Stages of Change questionnaire will be administered before each motivational interviewing session, and all outcome measures will be reassessed during follow-up evaluations. The study is expected to provide evidence regarding the effectiveness of Transtheoretical Model-based motivational interviewing in reducing smoking behavior, decreasing nicotine dependence, promoting progression through the stages of change, improving self-efficacy, enhancing the use of behavioral change processes, and supporting smoking cessation among nursing students.

Family-Based Financial Incentives Intervention for Smoking Cessation

The current study will conduct an RCT to evaluate the effectiveness of a family-based incentive intervention with Alaska Native/American Indian families. The experimental arm will be compared to a control arm on biochemically-confirmed smoking abstinence at 6- and 12-months post-intervention.

Libre Del Cigarrillo: Development of an mHealth Smoking Cessation App to Extend Reach of a Validated Smoking Cessation Intervention for Spanish-speaking Smokers

Pilot randomized controlled trial evaluating feasibility, acceptability, and trial-readiness of the new app compared with the existing print booklets and the NCI SmokefreeTXT en Español program.

Efficacy and Cost-Effectiveness of Cost-free Pharmacotherapy for Smoking Cessation for High-risk Smokers With Cerebrovascular Disease

Research Aims The aims of this research study are to determine whether cost-free smoking cessation pharmacotherapy: 1. Helps smokers with Transient Ischemic Attack (TIA) or stroke to quit smoking over the long-term, compared to simply providing a prescription for these medications; 2. Is a more cost-effective alternative to providing a prescription only for these medications in this high risk population. Hypotheses to be Tested The hypotheses to be tested include the following: 1. The CO-validated continuous abstinence rate at weeks 26 and 52 following a target quit date will be at least 10% higher for the cost-free smoking cessation pharmacotherapy intervention group compared to the prescription only usual care group; 2. Cost-free smoking cessation pharmacotherapy will have a greater cost-effectiveness (i.e., cost/quit) than providing a prescription only.

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.

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.

LLM Intervention for Tobacco in Underserved Populations (LIFT-UP)

This study will test a tailored, multilingual tobacco cessation chatbot called LIFT-UP (LLM Intervention for Tobacco in Underserved Populations), designed to better meet the needs of people living in persistent poverty census tracts. This study will use 1:1 semi-structured interviews to explore social drivers of health impacting TC, as well as digital access and preferences among those living in PPCTs. This qualitative approach enables guided yet flexible exploration of key domains while capturing unanticipated insights relevant to refining the chatbot.

Partnering With Food Bank to Provide Tobacco Treatment to Underserved Smokers

This study will evaluate the efficacy and economic impact of a theoretically-based, fully automated, interactive smartphone-based smoking cessation intervention.

THCV Treatment for Smokers

This study will randomize 32 non-treatment-seeking individuals who smoke cigarettes daily into a randomized, crossover, double-blind, placebo-controlled study testing the safety, tolerability, and initial efficacy of Δ9-tetrahydrocannabivarin (Δ9-THCV).

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.

Smoking Cessation Program for Lao People With HIV

Tobacco use remains the leading modifiable risk factor for preventing cancer globally, particularly among people with HIV (PWH). In Laos, 61-80% of male PWH and 3-10% of female PWH smoke cigarettes. PWH who smoke in Laos have no reliable smoking cessation support. Thus, implementing sustainable and evidence-based smoking cessation interventions for PWH in Laos is needed. The investigators developed a scalable and affordable mHealth-based automated treatment program (MAP) to support Lao and Cambodian smokers to quit smoking. MAP involves interactive, tailored, personalized content (text messages, photos, and videos) delivered via a smartphone app. Along with effective cessation treatments, it is imperative to implement procedures to identify patients who smoke and to connect them to treatment. Our team pioneered the Ask-Advise-Connect (AAC, asking patients about smoking at every visit, briefly advising those who smoke to quit, and connecting them to treatment) approach, which showed great impact in our previous US studies. The purpose of this study is to compare 2 smoking cessation implementation strategies in 8 antiretroviral therapy (ART) clinics in the 6 most populous regions in Laos, using a hybrid type-2 pragmatic effectiveness-implementation study and a parallel cluster randomized trial design. Specifically, the investigators will compare an AAC approach paired with our previously developed MAP (AA-MAP) to an AAC approach paired with less resource-intensive printed self-help material (AA-SH). The investigators will use the Practical, Robust Implementation and Sustainability Model (PRISM), which expands the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework to include more contextual factors relevant to program implementation. Aim 1 is to evaluate the reach and effectiveness of AA-MAP versus AA-SH. Reach is the proportion of PWH who smoke and are willing to make a quit attempt that enroll in treatment. Effectiveness is the proportion of enrolled participants who achieve biochemically confirmed point prevalence abstinence 6 months after enrollment. The investigators will also estimate the real-world impact (impact = reach × effectiveness) of each intervention. Aim 2 is to determine other implementation outcomes of AA-MAP and AA-SH. Aim 3 is to assess the resource use and costs of implementing AA-MAP and AA-SH. The project has the potential to transform HIV care and to reduce tobacco-related cancers and other morbidities.