Clinical Research Directory

Reducing Tobacco Smoking: a Transcranial Direct Current Stimulation (TDCS) Telehealth Study

The study aims to evaluate the feasibility of using Dorsolateral Prefrontal Cortex (DLPFC) Transcranial Direct Current Stimulation (tDCS) as a tool to decreasing distress and cigarette smoking. 46 participants currently smoking cigarettes, and seeking to decrease cigarette use will be recruited.

Smoke-free Home Intervention in Permanent Supportive Housing

The focus of this study is on expanding access to voluntary smoke-free homes to formerly homeless residents residing in permanent supportive housing and examining the impact of this intervention on reducing tobacco-caused disparities. In this study, the principal investigator will conduct a multi-site, community-based cluster-randomized wait-list controlled trial of the multi-faceted smoke-free home intervention among 400 permanent supportive housing residents residing in 20 permanent supportive housing sites across the San Francisco Bay Area with the goal of increasing voluntary adoption of smoke-free homes.

3A-OR Very Brief Tobacco Cessation Intervention in Primary Care

Introduction: Türkiye is far from the World Health Organization (WHO)'s target of reducing tobacco use prevalence by 30% by 2025. Most tobacco users consider quitting, and most have attempted to quit at least once. However, the success rate of quitting on one's own is quite low. Studies demonstrating that very brief tobacco cessation interventions delivered by healthcare professionals increase cessation rates have almost entirely been conducted in hospital settings. The aim of this trial is to investigate the effectiveness of implementing the 3A-OR (Ask - Assess - Advise - Offer Assistance - Record) very brief tobacco cessation intervention in routine primary care family medicine practice on the success of tobacco cessation. Methods/design: This protocol describes a two-arm, multicenter pragmatic trial for adolescent and adult tobacco users. The project will be carried out in family health centers in 21 study sites across the 12 statistical regions of Türkiye. In the intervention arm, volunteer family physicians will implement the 3A-OR very brief tobacco cessation intervention to their patients as part of their routine clinical practice. The intervention consists of the following steps: 'asking patients about their tobacco use status', 'assessing users' motivation to quit', 'advising quitting based on their motivation status', 'offering cessation assistance', and 'recording information regarding patients' tobacco use status and repeating the intervention at each patient contact'. Routine practice in family health centers will constitute the control group. Data will be collected using standard questionnaire forms at baseline and during follow-up interviews at 3, 6, and 12 months. Tobacco cessation rate and increase in smokers' motivation were the primary outcomes of the trial. Discussion: If the 3A-OR very brief tobacco cessation intervention is found to be effective, the results of this trial will provide evidence that will encourage the widespread use of the intervention in primary care family health centers. The study results are intended to be disseminated through the Family Medicine Academy Association website, conference presentations, and scientific publications.

VR Smoking Cessation During a Dental Hygiene Visit

The goal of this randomized controlled trial (RCT) is to test whether a smoking cessation induction intervention delivered during a dental cleaning appointment increases the utilization of evidence-based treatments (EBTs) for smoking cessation within 7 months post-dental cleaning appointment. Approximately 400 cigarette smokers who are scheduled for a dental cleaning appointment at the Boston University Goldman School of Dental Medicine (BUGSDM) patient treatment center will be recruited and enrolled. Participants will be randomized to either the intervention or control group

Smoking Cessation Treatment for Head & Neck Cancer Patients

This is Part 1 of a 2-part research study. The goal of this part of the study is to plan and test an investigational type of counseling called Acceptance and Commitment Therapy, for use in patients who have or had head and neck cancer, lung cancer, breast cancer, gastrointestinal cancer, or genitourinary cancer. This part of the study is also designed to train the study counselors how to perform Acceptance and Commitment Therapy. In this part of the study, participants will either receive Acceptance and Commitment Therapy or the standard type of counseling, called Motivational and Behavioral Counseling. This is Part 2 of a 2-part research study. In both parts of the study, participants receive either an investigational type of counseling (Acceptance and Commitment Therapy) or a standard type of counseling (Motivational and Behavioral Counseling). Part 1 was also designed to train the study counselors how to perform Acceptance and Commitment Therapy. The goal of Part 2 is to compare Acceptance and Commitment Therapy against Motivational and Behavioral Counseling. Researchers want to learn which type of counseling may be more effective in helping patients to stop smoking. These types of counseling will be tested in patients who have or had head and neck cancer, lung cancer, breast cancer, gastrointestinal cancer, or genitourinary cancer.

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.

Effectiveness of a Smoking Cessation Algorithm Integrated Into HIV Primary Care

To determine the efficacy of an algorithm designed to recommend smoking cessation-related pharmacotherapy options to the primary care providers of smokers living with HIV/AIDS.

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.

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.

PASCAL Feasibility Study

The goal of this randomized study is to assess if a conversational agent (or chatbot) that the investigators have developed to help with quitting smoking is acceptable to people trying to quit smoking and to also collect initial information regarding its effectiveness. In this study, some participants trying to quit smoking will be provided with this chatbot while other participants will not be

Clinical Research Evaluating Smoking Cessation With E-Cigarettes and Nicotine Therapy

This project will investigate the effects of alternative nicotine products on smoking, weight gain, and related outcomes.

Testing an MBI for Smoking Cessation and Alcohol Use Among Cancer Survivors

This study will examine the efficacy of Mindfulness-Based Relapse Prevention for Smoking and Alcohol (MBRP-SA) compared to standard care among cancer survivors who smoke cigarettes and engage in at-risk alcohol use. Investigators will evaluate implementation outcomes through structured stakeholder interviews across medical centers, cancer-focused organizations, and community-based programs in Florida, and will conduct a cost-assessment and an incremental cost-effectiveness analysis of the two conditions.

Measuring Communal Coping in Dual-smoking Couples Making a Quit Attempt

Smoking is the leading preventable cause of death in the United States, and quitting is especially difficult for couples who both smoke. When both partners smoke, they are less likely to quit successfully and more likely to relapse compared to people whose partner does not smoke. Research suggests that the way romantic partners interact and support each other during a quit attempt can make a real difference - but researchers do not yet know enough about what kinds of support actually help. This study examines a concept called "communal coping," which refers to when partners treat a shared health challenge - like quitting smoking - as something they are facing together as a team rather than as separate individuals. Researchers believe that couples who approach quitting this way may have better outcomes. To study this, researchers will ask both members of dual-smoking couples to complete brief daily surveys over two weeks while making a quit attempt. These surveys will track how partners support (or discourage) each other's quitting efforts on a day-to-day basis, along with cigarette use, cravings, and stress. This will help researchers understand which relationship patterns are most helpful for quitting, and identify specific targets for future couples-based smoking cessation programs.

Creation of an Infrastructure to Support Delivery of mHealth Interventions for Cancer Patients

Despite the deleterious impact of smoking upon cancer treatment outcomes, smoking prevalence remains alarmingly high among cancer patients. Thus, reducing smoking by cancer patients is a public health priority, but treatments to date have demonstrated limited efficacy. Mobile health (mHealth) interventions have the potential to improve treatment efficacy while also greatly extending reach. The goal of this infrastructure proposal is to build a resource to facilitate the creation of mHealth tools that address the tobacco treatment needs of cancer patients. This resource, which will be available to researchers throughout Florida, would fill a critical gap in mHealth capacity.

Interventions for Maximizing Patient And Family Smoking Cessation Together

This feasibility study evaluates the effectiveness of a household-based smoking cessation intervention for patients and their household members. Patients who smoke and live with household members who also smoke will be invited to participate in the Treating Tobacco Dependency (TTD) program at Royal Papworth Hospital. The study aims to assess whether providing support to both patients and their household members improves quit rates and reduces relapse risk. Participants will receive nicotine replacement therapy (NRT) and behavioural support, with follow-up assessments at 28 days, 3 months, and 12 months after starting the program. This study will compare outcomes to historical data from patients who participated in the TTD program without household support.

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.

Adaptive Mobile Interventions to Reduce Cancer Risk Behaviors

Tobacco use remains the leading cause of preventable death, causing over 400,000 annual deaths in the United States alone. Smartphone-based interventions, particularly those leveraging real-time adaptive messaging, represent a promising yet underutilized approach to delivering personalized tobacco and cannabis treatment. The investigator's ongoing NCI funded micro-randomized trial (MRT; R01 CA246590) has shown initial feasibility in reducing smoking urges through situationally tailored cognitive-behavioral therapy (CBT) and mindfulness-based acceptance and commitment-based therapy (ACT) messages triggered by real-time contextual data (e.g., geolocation, momentary stress). To advance from a static MRT framework to a dynamic, data-driven just-in-time adaptive intervention (JITAI), this project aims to develop, test, and refine a reinforcement learning (RL) algorithm that can continuously adapt to user needs in real-time, enhancing treatment outcomes for various tobacco and cannabis products. To ensure optimal usability and engagement, the investigators will conduct user-centered testing with the developed RL-based intervention delivery in one cohort (N=7) over 45 days. This will include usability assessment via the System Usability Scale, analysis of app interaction metrics, and semi-structured interviews to gather feedback for refining message content, timing, and design.

Small Financial Incentives to Promote Smoking Cessation

The primary objectives of this study are 1) to evaluate the longer-term impact of an adjunctive, low-cost financial incentives intervention (relative to standard care) on smoking abstinence rates among socioeconomically disadvantaged individuals participating in a clinic-based smoking cessation program and 2) to identify treatment mechanisms and contextual factors associated with cessation outcomes among intervention participants using both traditional and ecological momentary assessment approaches. Those randomized to the financial incentives intervention will have the opportunity to earn small gift cards for biochemically-verified abstinence through 12 weeks post-quit. We hypothesize that individuals who are randomly assigned to the adjunctive CM intervention will have significantly higher rates of biochemically-verified abstinence at the 26-week post-quit follow-up than those assigned to Usual Care. In addition, we hypothesize that several factors related to socioeconomic disadvantage will be directly associated with non-abstinence, especially greater stress/adversity, limited psychosocial resources, greater negative affect, greater nicotine dependence, and poorer treatment adherence. The primary study endpoints will include self-reported tobacco use/abstinence, expired carbon monoxide (CO) levels (i.e., the amount of carbon monoxide present in an individual's breath when they breathe out), and saliva cotinine levels at 26 weeks post-quit attempt, though smoking status will be assessed at all visits. Traditional questionnaire measurement and ecological momentary assessment (EMA) will be utilized to measure potential treatment mechanisms including motivation, self-efficacy, and treatment adherence. Other variables including stress/adversity, psychosocial resources, negative affect, nicotine dependence, and treatment adherence will also be assessed.

Empowering Cessation ACS South Region

Sexual and/or gender minority (SGM) people face a disproportionate burden of cancer risk, and tobacco use is a key modifiable risk factor. SGM tobacco-related disparities are especially pronounced in places with high levels of stigma against SGM people. This community-engaged and remotely-delivered Research Scholar Grant project will evaluate an empowerment-based smoking cessation intervention tailored for SGM people in high-stigma places. In partnership with Freedom Oklahoma (OK) and a Community Advisory Board from Arkansas (AR) and Texas (TX) this projects aims to: (1) Adapt SGM-serving volunteer activities from the Oklahoma intervention pilot study for delivery in nearby states; (2) Test intervention efficacy among SGM adults in OK, AR, and TX; (3) Identify treatment mechanisms.

Construal Level as a Novel Pathway for Affect Regulation and Cancer Control

The objective of the proposed research is to conduct a longitudinal experiment on the neurocognitive pathways and individual differences in high-level construal for affect regulation and smoking cessation. The population is adult smokers aged 25-55 who have tried and failed to quit and who are experiencing poverty. The primary endpoints are (a) the similarity in neural representation of high-level construal to one of two candidate pathways, (b) the presence of meaningful individual differences in the neural representation of high-level construal, and (c) as a secondary endpoint, the effect size of the high-level construal condition on smoking as measured by cigarettes per day. Each of these endpoints corresponds to a specific null hypothesis. The null hypothesis for the first endpoint is that high-level construal is not significantly different in its neural representation from down-regulation of craving, which would suggest that high-level construal does not operate through distinct mechanisms from traditional treatments. The null hypothesis for the second endpoint is that the between-subjects variability in the neural representation of construal level does not significantly relate to relevant individual differences measures (e.g., traits, task behavior), which would suggest that individual differences are not meaningfully related to outcomes. Finally, the null hypothesis for the secondary endpoint is that the magnitude of the effect of high-level construal on smoking as measured by reductions in average cigarettes per day is not significantly greater than in the other conditions, which would suggest that the efficacy of the high-level construal condition is not significantly greater than a standard text-messaging intervention. The primary endpoints will be assessed at baseline and change from pre-to-post training (8 weeks).

Scalable TELeheaLth Cancer CARe: The STELLAR Program to Treat Cancer Risk Behaviors

The goal of this clinical trial is to improve cancer patient's health, survival, and quality of life by dispelling risk behaviors for Northwestern Memorial Health Care (NMHC) patients who are cancer survivors. The main question\[s\] STELLAR aims to answer are: * How best to combine three behavior interventions (physical activity promotion, smoking cessation, obesity treatment) into one treatment. * Evaluate the reach of the program. We will look at the number, proportion, and representativeness of participants in terms of disease characteristics, socioeconomic status, telehealth readiness, and race/ethnicity. * Evaluate the effects of the STELLAR program relative to enhanced usual care (information provision) on cancer risk behaviors, patient care access, care quality, and communication. Participants will be provided goals related to their physical activity, smoking, and/or weight loss and asked to track their health behaviors via an app, excel file, or on paper. At baseline, 3 months, 6 months and 9 months into the study, participants will provide survey responses and physical measurements like height and weight. Additionally, those in the Facilitated group will complete 12 telehealth sessions with study staff to discuss progress towards their study goals. Researchers will compare the Facilitated group to the Self Guided group to see if the Facilitated intervention group is able to reach more participants that enhances care only.

TirolGESUND: Baseline-controlled Comparison of the Effects of Fasting Dietary Intervention or Smoking Cessation Combined With Exercise in Healthy Female Tyrolean Volunteers Aged 30-60 on Epigenetic and Multi-omic Biomarkers of Health, Ageing, and Disease

The goal of this clinical study is to learn about disease-risk and age-associated changes in DNA methylation patterns associated with disease risk or age in healthy women aged 30-60 in response to health-promoting lifestyle intervention (intermittent fasting or smoking cessation). The main questions the study aims to answer are: * Are the scores of DNA methylation in epigenetic signatures associated with age, women's cancer risk, or risk exposure reduced after 6 months of lifestyle intervention compared to baseline? * What are the dynamics of DNA methylation changes during or following intervention, and do differences in changes between different sample types exist? * Which other biomarkers of health and disease, including metabolic changes, microbiome, clinical, mental, or inflammatory parameters, are altered following intervention? The investigators also aim to explore whether DNA methylation changes are associated with changes in other biomarkers mentioned above. Participants will be allocated to intermittent fasting or smoking cessation based on inclusion criteria. Intermittent fasting encompasses a 16:8 intermittent fasting schedule. Food intake is limited to an 8 h window per day with fasting for the remaining 16 h. Within the intermittent fasting study, participants are randomised to receive a ketogenic supplement (medium-chain triglyceride fibre) or not. Participants in the smoking cessation study will be guided to stop smoking. All participants will receive 1:1 personal coaching throughout the study, and will be provided with an optional exercise programme. All participants will also receive nutritional advice from a professional dietician throughout the study. Participants are invited to donate samples every 2 months for 6 months. Researchers will compare signatures at the start and after 6 months of intervention. Within the intermittent fasting group, researchers will compare effects in individuals that received the ketogenic supplement to those that did not.

Developing Empowering Smoking Cessation

Problem: Despite encouraging use declines in the U.S. population, tobacco is still a leading cause of preventable disease and death. Current cessation treatments have limited success; two-thirds relapse within 6 months of a quit attempt. Existing smoking cessation interventions overwhelmingly focus on within-person processes of behavior change rather than socioenvironmental influences on cessation success. Cessation interventions based on evidence linking social stress to increased nicotine dependence and relapse risk are needed to address the stressors people who smoke encounter while navigating their social environments (i.e., social stress). Effective empowering approaches for infectious disease prevention and youth tobacco use suggest that Empowerment Theory may also enhance smoking cessation assistance for people experiencing high levels of social stress. Hypothesis: Our hypothesis is that when people participate in community-serving volunteer activities, they may also experience cognitive and behavioral changes (i.e., enhanced stress coping, social support, self-worth, prosociality) that ameliorate the effects of social stress, thereby supporting smoking cessation. Importance: Empowerment Theory-informed health behavior change approaches have worked for infectious disease prevention and youth tobacco interventions. Our pretest (N=20; Oklahoma) demonstrated the feasibility and acceptability of volunteer activity participation as an adjunct to standard smoking cessation treatment. This novel smoking cessation intervention uses an innovative, theory-based, local-yet-scalable approach to enhance individual outcomes through community engagement. To ensure scalability and accessibility of this remotely delivered intervention, we will utilize the NIH-supported Dissemination and Implementation (D\&I) science framework, the Practical, Robust Implementation and Sustainability Model (PRISM), which is the contextually expanded version of RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance). This project will advance efforts to understand and address high tobacco use among people experiencing high levels of social stress and will inform a future R01 application for a fully-powered, multi-site RCT of ECHO aiming to end tobacco use across the U.S. while supporting community connectedness.

Pain and Smoking Study - Interactive Voice Response

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 Interactive Voice Response (IVR) to optimize the intervention's effectiveness for smoking cessation among Veteran smokers with chronic pain.