Clinical Research Directory

Implementing Tobacco Treatment in Low Dose CT Lung Cancer Screening Sites

This study is to help determine the most effective type or combination of treatments to offer patients seeking lung cancer screening who are smokers to help them reduce the number of cigarettes they smoke, or quit smoking. The investigators long term goal is to increase the benefits of lung cancer screening by providing a blue print of best practices for screening sites to deliver tobacco treatment to their patients who are smokers, in a way that does not add burden to screening site staff and increases the chances of patients quitting smoking.

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.

§SMOKE Nicotine and Tobacco Youth Cohort

The §SMOKE Cohort Study aims to improve understanding of tobacco and nicotine use among adolescents and young adults in Denmark. The study focuses on a rapidly changing nicotine landscape that includes cigarettes, e-cigarettes, nicotine pouches, heated tobacco products, and other nicotine products. The study is based on the hypothesis that tobacco and nicotine use during adolescence and young adulthood follows different developmental pathways and that individual characteristics, social influences, and environmental factors affect initiation, continued use, cessation, relapse, and switching between products. The study further hypothesizes that different patterns of tobacco and nicotine use are associated with differences in educational, health, and social outcomes. By following young people over time, the study seeks to improve understanding of how tobacco and nicotine use develops, which factors influence these behaviors, and what consequences may be associated with different patterns of use. The findings will contribute to evidence supporting tobacco and nicotine prevention efforts and public health policy for adolescents and young adults in Denmark.

Smoking Cessation Intervention During Low Dose CT (LDCT) Screening for Lung Cancer

The goal of this clinical research study is to offer lung cancer screenings to smokers who want to change their smoking behaviors. All eligible participants will receive smoking cessation counseling and may be offered at least one form of smoking cessation drug. Different forms of counseling (the delivery of counseling and access to counseling) will be compared. This is an investigational study. Participants on this study will not be prescribed smoking drugs directly by the study staff. However, participants in this study may or may not receive smoking cessation drugs, depending on what the provider thinks is in the participants best interest. All smoking cessation drugs being used are FDA approved and commercially available. It is investigational to compare the different forms of counseling participants receive. Up to 1260 participants will be enrolled in this study. All will take part at MD Anderson.

Comparing the Efficacy of a Conversational Agent (QuitBot) Versus Standard Health Education on Smoking Cessation Among Medical Students in Cairo University

Comparing the efficacy of conversational agent and standard health education in promoting smoking cessation among medical students in Cairo university

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.

New Smoking Cessation Intervention in Primary Care - a Randomized Controlled Trial

Cigarette smoking remains the leading modifiable risk factor for lung cancer4 and 16 other types of cancer, as well as chronic cardiovascular and pulmonary diseases. Despite public health efforts, smoking prevalence remains a major national as well as international challenge. Currently in Norway 16% of those 25-74 years of age are still daily or occasional smokers (9% and 7%, respectively), projecting a 10% of smoking prevalence during the current decade. In Europe it was estimated to be more than 183 millions current and former smokers (42% of the population) in 2017. Thus, smoking is a central public health issue nationally and internationally. Smoking cessation not only significantly reduces lung cancer risk and other smoking related diseases, but also improves life expectancy, making this intervention a critical component of primary cancer prevention. Despite a decline in smoking rates, approximately 10% of Norwegians still smoke, with non-daily smoking on the rise among young people (16-24 years), affecting 19% of men and 13% of women. This underscores the urgent need for more effective cessation strategies. A number of smoking cessation treatments have been developed, but the majority of people relapse within the first year of cessation. Primary care faces significant barriers in delivering effective smoking cessation interventions. On the clinician side, challenges include a lack of personalized treatment options, time constraints, and unclear guidelines. From the patient perspective, there is often a lack of motivation and a perception that treatments are not tailored to individual needs. This project aims to evaluate the effectiveness of a newly developed, personalized smoking cessation app designed to assists GPs in providing tailored smoking cessation treatments. Specifically, we will test whether the use of this app results in improved smoking cessation outcomes and enhanced quality of life for smokers in primary healthcare settings, compared to the current standard smoking cessation treatments. Based on the results from the app, GPs will receive advice on how to motivate this particular person to quit smoking. The point of the app is that healthcare professionals will be able to provide a more personalized smoking cessation treatment based on the information that the smoker has entered into the app compared to current practice. Our hypothesis is that by using our newly developed app, healthcare professionals will be able to achieve better smoking cessation results compared to the standard smoking cessation approach used today. The project is a clinical randomized-controlled phase 3 study in which we, through GP offices across the country, will include smokers who want to quit smoking to test this app. The intervention group (n=310) will be a group of smokers where the GP uses the app to help them quit smoking, while the control group (n=310) will be smokers who only receive regular smoking cessation treatment as is currently provided by GPs. The health benefits of increased smoking cessation success rates are major, including prevention of various cancers as well as other chronic smoking-related diseases such as cardiovascular disease and lung disease e.g. COPD. This will in turn provide significant cost savings at a societal level.

Contingency Management to Promote Smoking Cessation Study

Adherence to medication and counseling are strong predictors of smoking cessation success. To provide these two components of care, healthcare providers typically provide people who smoke with prescriptions for cessation medications, and refer them to state-sponsored tobacco quitlines. However, most people who smoke that are referred to quitlines never actually enroll, and those who do enroll participate in very few sessions. Similarly, most people who smoke that receive prescriptions for cessation medications rarely fill or use them, even when they have no co-pay or pre-authorization requirements. To address this problem, the investigators will recruit 40 patients for a pilot 2-arm effectiveness trial. Investigators will recruit patients from the University of Kansas Medical Center. Participants will then be randomized either to control or Health Reward. All participants will receive 12 weeks of varenicline and referrals to their state tobacco quitline (Control condition). In Health rewards arm, participants will additionally receive CM for medication (MedCM) and for counseling (CounsCM). The use of medication will be tracked using an electronic pill dispenser (Wisepill). All participants will be contacted for follow up 3, 6 and 12 weeks after starting the treatment. Feasibility data will include recruitment and retention rates. Preliminary effectiveness outcomes will include treatment engagement and cessation rates.

BAPS in Botswana: The Thotloetso Trial

The main purpose of this research study is to compare traditional behavioral smoking cessation therapy with a different type of behavioral therapy-known as behavioral activation problem solving (BAPS)-for smoking cessation. Standard smoking cessation counseling (SC) focuses on self-monitoring, identifying smoking triggers and how to manage them, relaxation and social support for non-smoking, and relapse prevention. BAPS focuses on recognizing he feelings you are having that lead to smoking and how to overcome those feelings and focus on activities that discourage you from smoking and avoid activities that encourage you to smoke. Both counseling types include gathering information about your personal smoking patterns, your likes, dislikes, and other personal characteristics about your lifestyle. Half of participants who enroll in the study will receive standard smoking cessation counseling (SC) and half will receive BAPS counseling. We will compare the rates of quitting smoking across the two groups at the end of treatment (study week 10), and 12 weeks after the end of treatment (study week 26)

A Study of Nicotine Orodispersible Tablet on Craving Relief of Male and Female Smoker Volunteers

The objective of the study is to evaluate the relief of momentary urge to smoke at pre-specified early post-dose time points after administration of Nic ODT compared to Placebo ODT.

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.

Collection of Airway, Blood and/or Urine Specimens From Subjects for Research Studies

The purpose of this study is to obtain biologic materials from the blood, airways and/or urine of normal individuals and individuals with lung disease. The normal are used to establish a set of normal ranges for various parameters. These provide control information when compared to individuals with various pulmonary diseases, and will help in understanding of the etiology and pathogenesis of various lung diseases. The underlying hypothesis is that the pathologic morphological changes in the airway epithelium must be preceded by changes in the gene expression pattern of the airway epithelium and potentially in macrophages.

The Next Step in Smoking Prevention: the Reduction of Tobacco Retail Outlets, a Comprehensive Policy Evaluation

Few countries have legislation to reduce the number and types of tobacco retail outlets. The Netherlands plans to ban tobacco sales in supermarkets in 2024. The overall aim of this proposed research is to evaluate the implementation of new legislation to reduce the number and types of tobacco outlets in the Netherlands, up until and including the ban on sales of tobacco in supermarkets. In a comprehensive policy evaluation, the investigators plan to examine (1) the impact of the policy on the number and types of tobacco outlets, (2) the impact on attitudes and behaviors of smoking adults and non-smoking youth, and (3) the influence of the tobacco industry on the policy process and the retail environment. In addition, the investigators plan to focus on differential effects in disadvantaged neighborhoods, where both smoking rates and tobacco outlet density are typically highest. The investigators bring together a unique combination of economic, psychological, and journalistic research methods. The investigators examine the impact of the new legislation on the amount and type of tobacco outlets and on the number of smokers by using routinely collected monitoring data. The investigators examine the impact of the legislation on smoking susceptibility of non-smoking youth and on impulse tobacco purchases by smoking adults with yearly quantitative surveys (two surveys before the policy implementation and two after) and with qualitative interviews and discussion sessions. The investigators examine whether these impacts differ for disadvantaged versus non-disadvantaged neighborhoods. The investigators examine what strategies the tobacco industry uses to influence the new legislation, policy processes, and the tobacco retail environment by performing a journalistic investigation, using for example documents obtained by Freedom of Information Act requests, (possibly) leaked documents from insider meetings, and interviews with insiders. Our research will provide a comprehensive evaluation of the effects of the implementation of the proposed legislative measures. Based on our results, the investigators will formulate recommendations for the Dutch Cancer Society, the Dutch government, and for other countries who consider reducing the number of tobacco outlets; highlight potential areas for further development and improvement within the legislative framework and provide recommendations on how to counter the lobby from the tobacco industry.

Improving Adherence to Web-Based Cessation Programs: A Social Network Approach

This study will compare the efficacy of an interactive, evidence-based smoking cessation website (WEB) alone and in conjunction with 1) a theory-driven, empirically-informed social network (SN) protocol designed to integrate participants into the online community, and 2) access to a 4-week supply of free NRT.

THE EFFECT OF A TRANSTHEORETICAL MODEL-BASED CHATBOT SUPPORT INTERVENTION ON SMOKING BEHAVIOR IN UNIVERSITY STUDENTS

The purpose of this clinical trial is to examine the impact of a chatbot-supported intervention based on the Transtheoretical Model (TTM) on smoking behavior, self-efficacy, decisional balance, and the urge to smoke among university students. The main questions it aims to answer are: * Does the chatbot-based support intervention, grounded in the Transtheoretical Model (TTM), have an effect on smoking behavior? * Does the chatbot-based support intervention, grounded in the Transtheoretical Model (TTM), have an effect on self-efficacy levels? * Does the chatbot-based support intervention, grounded in the Transtheoretical Model (TTM), have an effect on decisional balance? * Does the chatbot-based support intervention, grounded in the Transtheoretical Model (TTM), have an effect on the urge to smoke? The researchers will compare the experimental group with a group that received no intervention to determine whether the chatbot is effective in influencing smoking behavior. Participants will: * Complete the preliminary assessment questionnaire. * If you are in the experimental group, access the Telegram chatbot via the provided link and exchange messages with the bot once a week for a total of 6 weeks (each session will take approximately 10 minutes). Additionally, read the informational messages sent twice a week and try to incorporate the suggestions into your daily life. * Complete the follow-up questionnaires that will be sent after 6 weeks and again after 3 months.

Impact of Lung Cancer Screening With Chest Scans Combined With Coaching on Smoking Cessation in Heavy Smokers

Lung cancer is common and serious, but when detected early, the chances of recovery are significantly better. Tobacco use is the leading cause. To help people break free from smoking, the Fribourg Cantonal Hospital (HFR), the Center for Tobacco Prevention (CIPRET), and the Fribourg Cancer League are joining forces in the STOP-LungCancer study (Smoking Termination Outcomes with Pulmonary Low Dose Computed Tomography for Lung Cancer Screening). What is the goal of this study? The investigators want to determine whether seeing and understanding images of the participants' own lungs helps participants quit smoking for good. Smoking cessation will be verified at 6 months using a breath test (measuring carbon monoxide), followed by a 2-year follow-up. How does participation work? The study is open to 116 residents of the canton of Fribourg aged 50 to 79 who are heavy smokers and motivated to quit. The program includes: 1. Personalized support: 4 smoking cessation coaching sessions organized by CIPRET. 2. Lung computed tomography (CT) scans: 3 exams spaced one year apart. This scan involves no needles or injections. The radiation dose is very low, about 0.6 millisieverts (mSv) per scan, and the associated risk is considered very low. 3. A review of the images with a doctor: During dedicated consultations, a thoracic radiologist reviews the participant's own computed tomography (CT) scans with the participant to explain the condition of the lungs and heart. What are the benefits? Participants receive both tailored support to quit smoking and close monitoring to detect any potential issues at a very early stage.

Evaluating Smoking Cessation Interventions for PWH in South Africa

The overall objective of the study is to optimize a smoking cessation treatment package for people with HIV (PWH) that can be integrated into existing HIV care in South Africa.

Testing the Efficacy of A Scalable, Telephone-Delivered, Guided Imagery Tobacco Cessation Intervention

The objective of this R01 application is to conduct a randomized controlled trial to test the efficacy of the Be Smoke Free, telephone-based, guided imagery (GI) intervention (IC) for smoking cessation compared to active behavioral control (CC). The study will recruit 1,200 diverse smokers from three states, Arizona, New York, and West Virginia to increase generalizability. Participants will be randomly assigned to receive either the IC or CC delivered by telephone by University of Arizona study coaches and will be assessed at 3- and 6-months post-enrollment by study staff. The primary outcome is biochemically verified 7-day point prevalence abstinence at 6 months. This innovative and rigorously designed project conducted by an experienced team has the potential to improve public health through the delivery of an innovative integrative GI intervention via telephone.

Baby Steps III: Testing a Clinician and Patient Intervention to Promote Smoking Cessation Among Pregnant Women

The investigators propose to conduct a combined intervention that pairs SMS smoking cessation messages for patients with individualized training for OB clinicians to improve quit rates among pregnant smoking. The aim is to determine the effect of the intervention versus control on smoking cessation outcomes on patient smoking cessation. The investigators will recruit patients at their first OB visit who report smoking at Duke and Pitt. Patients in both the control and intervention arm will receive smoking cessation support messages throughout their pregnancy. OB clinicians in the intervention arm will receive tailored smoking cessation counseling training. Clinicians in both arms will receive a one-time 5 A lecture. The investigators will analyze smoking cessation outcomes and audio recordings. This is a minimal risk study.

ChatGPT-Supported Text Messaging Program for Smoking Cessation

The current research proposal aims to explore how a purpose driven LLM ChatGPT chatbot, BeFreeBot, might enhance an evidence-based text messaging smoking cessation program, BeFree. The research will consist of a formative evaluation comparing quitting related outcomes among users of BeFree+Bot and BeFree.

Testing the mHealth App Intervention for Nondaily Smokers "SiS4"

The goal of this project is to test if a new behavioral treatment for people who smoke nondaily and wish to quit works. The new treatment is a smartphone app that engages users in positive psychology exercises and gives them tested tools for quitting smoking. The positive psychology exercises help users maintain their positive emotions while they quit smoking. This app has been developed with and for people who smoke nondaily through several steps of development. The main questions it aims to answer are: * Does the smoking cessation app (SiS4) help people who smoke nondaily quit smoking? * How do people's attitudes towards smoking, their smoking urges, and their mental well-being shift when using the SiS4 app? Researchers will compare the new app to an existing app that was developed for people who smoke daily to see if the new app works better to help people who smoke nondaily quit smoking. Participants will: 1. Use a smartphone app every day for 7 weeks 2. Complete online surveys about their smoking, attitudes about smoking, withdrawal symptoms and smoking urges, app use, and mental well-being at enrollment as well as 2 weeks, 6 weeks, 3 months, 6 months and 12 months after the initially chosen quit date. If the SiS4 app works well, it would be the first evidence-based quit-smoking treatment for people who smoke nondaily.

Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)

This study is a Phase 3, multicenter, randomized, double-blind, placebo- and active-controlled, parallel-group trial to evaluate the efficacy and safety of AXS-05 compared to placebo and bupropion for smoking cessation in adults.

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.

Effectiveness of Transcranial Magnetic Stimulation (TMS) in Smoking Cessation, Combining Withdrawal Stimulation Followed by Maintenance Stimulation to Prevent Relapse.

Tobacco control is a Public Health priority. Tobacco is directly responsible for 75,000 deaths per year in France. Without help, less than 5% of smokers are still abstinent within 12 months of quitting. The use of nicotine substitutes only increases the chances of success in smoking cessation by 2 to 3%. Brain imaging research shows that the dorsolateral prefrontal cortex (DLPFC) is involved in tobacco addiction. Disorders induced in the CPFDL cause an irrepressible desire to smoke (craving) and explain a large part of the relapse at the time of smoking cessation. Transcranial magnetic stimulation (TMS) could be promising in smoking cessation. This technique allows direct stimulation of the DLPFC via a magnetic coil, so as to reduce the cortical activity of the DLPFC, and thus reduce tobacco craving. A first randomized controlled study was conducted at the Dijon University Hospital in Dijon in smokers who were heavily addicted and who had failed with the usual withdrawal strategies. In this study, it was found that the combination of nicotine substitutes (to reduce the physical symptoms of withdrawal) with 10 sessions of TCS (to reduce craving) made it possible to maintain abstinence from tobacco during the first 2 weeks of withdrawal (% abstinence = 88.8% active TCS group vs. 50% placebo TCS group; p=0.027). However, in this study, the therapeutic effect of the nicotine-TCS combination was not prolonged once the stimuli stopped. At 6 and 12 weeks from the start of withdrawal, abstinence rates in the active SMT and placebo SMT groups were no longer significantly different. It is therefore proposed to renew the protocol by adding maintenance brain stimulation to the initial protocol. Used in the treatment of depression, the maintenance brain stimuli could increase the chances of smoking cessation.