Smoking Cessation

Researchers are studying whether treatment decision-making can be improved for smokers who have difficulty quitting with medications. This trial focuses on smokers seeking to quit and evaluates adaptive treatment strategies using FDA-approved options. The goal is to find the best approach for each person by adjusting the treatment based on early response to medications. The study is sponsored by the Medical University of South Carolina and is designed as a randomized clinical trial without masking. Participants will receive a free 12-week course of nicotine replacement therapies (patches and lozenges), varenicline, or e-cigarettes as harm reduction products. Initially, smokers are randomized to either varenicline or combination NRT for four weeks. Those showing early success continue the same medication, while non-responders may switch to the other medication or continue the same one, with further adjustments made at weeks 4 and 8. After 12 weeks, no more products are provided. All study visits and assessments are conducted remotely through phone calls and surveys. Participants will complete eight surveys over six months, including a follow-up survey six months after the initial call. Researchers will measure smoking cessation success and dependence outcomes, with primary outcomes assessed at 8 weeks and final outcomes at 24 weeks. The study allows for safety monitoring throughout and involves no in-person visits.

This research aims to develop and test a culturally tailored smartphone app called HealthyCells to help African American smokers quit smoking and reduce sedentary behavior. African Americans have higher quit attempts but lower success rates compared to other groups. By integrating two proven smartphone interventions, the study seeks to address barriers and promote cessation and activity using tailored content that considers cultural strengths and challenges. HealthyCells combines a smoking cessation app with features like facial recognition to verify smoking status twice daily using carbon monoxide breath samples, and activity monitoring via a Google smartwatch. The app sends real-time prompts to encourage movement after 30 minutes of sitting and delivers motivational messages twice daily to support quitting and reduce sedentary time. The study includes a pilot phase with 15 African American smokers to refine the app, followed by a main phase where 30 participants will use HealthyCells during a planned quit attempt. Participants will engage in smoking status assessments and activity monitoring remotely, with rewards for abstinence based on biochemical verification at 8 weeks. Sedentary time will be measured by accelerometer for 7 days before quitting and 7 days at 8 weeks post-quit. The research team will evaluate smoking abstinence rates and changes in sedentary behavior to determine the app's feasibility. The total study participation is focused on the 8-week period post-quit date, with frequent assessments and feedback via the app.

Researchers are evaluating how an indoor air quality monitor can help promote smoke-free homes among cancer patients who are currently enrolled in Memorial Sloan Kettering's Tobacco Treatment Program. This study focuses on encouraging smoke-free environments to support tobacco cessation efforts in this group of patients. Participants who are current smokers and receiving tobacco treatment at MSK will be asked to use the Indoor Air Quality Monitor AirGradient ONE, a commercially available device designed to measure indoor air pollution levels for up to 8 weeks. The study will observe how participants set up and use this device in their homes and attend smoke-free workshop sessions. During the study, researchers will track how many participants use the air quality monitor for 14 consecutive days within the 8-week period and how many attend the smoke-free workshops. Participants will be monitored through phone contact and must have Wi-Fi at home to support device use. The study will last up to 8 weeks, with data collected on device usage and workshop attendance to assess the impact on promoting smoke-free homes.

Researchers are evaluating the effectiveness of varenicline, compared to a placebo, for helping adults who regularly use e-cigarettes to quit. This phase 2 randomized, placebo-controlled trial focuses on treatment-seeking adults who report daily e-cigarette use, aiming to understand if varenicline can increase quit rates and how quitting affects health-related biomarkers. Participants will be randomly assigned to one of two groups: one group will receive varenicline titrated to 2 mg daily over 12 weeks along with brief counseling and self-management resources, while the other group will receive a matching placebo with the same counseling and resources. Assessments will occur every 3 weeks during the treatment period, with a final follow-up at week 26. Throughout the study, participants will complete evaluations every three weeks and a final visit at 26 weeks to measure abstinence from e-cigarette use and assess changes in health biomarkers related to cessation. The primary outcome is the number of participants abstinent at week 12, with additional outcomes measured at week 26. The study includes monitoring for safety and treatment adherence over the 26-week period.

Researchers are evaluating the abuse potential of five modern oral nicotine products compared to combustible cigarettes and nicotine gum in generally healthy adult smokers aged 21 to 60 years. This open-label, randomized, cross-over study aims to assess subjective effects, physiological responses, and nicotine levels in the blood during and after use of these products. The study includes smokers who primarily use filtered menthol or non-menthol cigarettes, including those who also use smokeless tobacco or modern oral products. Participants will be randomly assigned to one of two study arms and use four different investigational products in separate test sessions following a Williams Design. The products include various nicotine doses delivered orally and participants' usual brand cigarettes or nicotine gum, depending on their arm. Each test session lasts about 4 hours and is preceded by a product acclimation period allowing ad libitum use of the next study product. Used products are collected and stored for laboratory analysis. Participants will stay confined at the clinical site for 6 days (5 nights) during which safety and effects will be closely monitored through vital signs, physical and oral exams, adverse event tracking, laboratory tests, and questionnaires. The main outcomes measured include nicotine uptake and peak response from 5 to 240 minutes after product use. The study also includes screening, eligibility confirmation, and follow-up availability by the medical monitor, with careful monitoring throughout the trial period.

Researchers are evaluating a counseling and educational program aimed at improving lung health by helping Chinese and Korean American smokers at high risk for lung cancer to quit smoking. This randomized clinical trial compares the effectiveness of the ACT Lung Health Intervention with standard care, focusing on smoking cessation and lung cancer screening behaviors. Participants will be randomly assigned to one of two groups. Group A receives the ACT Lung Health Intervention, which includes eight weekly counseling sessions via phone or video, family coaching, nicotine replacement therapy (patches, gum, lozenges), and educational materials about lung cancer screening with low-dose computed tomography (LDCT). Group B receives standard care with six counseling sessions, nicotine replacement therapy, and educational materials. Both groups undergo assessments at baseline, 1, 3, and 6 months, including saliva tests at 3 and 6 months. Participants will complete questionnaires and saliva tests to monitor smoking abstinence and lung cancer screening completion. The primary outcome is biochemically verified smoking abstinence at 6 months. Secondary outcomes include changes in cigarette consumption, self-reported abstinence at 3 and 6 months, and lung cancer screening completion. The study lasts approximately 6 months and involves about 50 participants, with safety monitored throughout the trial.

Researchers are evaluating the effectiveness of Actívatexto, a mobile intervention designed to help Latino adults who smoke quit smoking and increase their physical activity. This randomized controlled trial compares Actívatexto, which promotes both smoking cessation and physical activity, to Decídetexto, which focuses solely on smoking cessation. The study aims to understand how well these interventions work, with special attention to the factors that influence treatment effects among Latino smokers who do not meet recommended physical activity levels. Participants are randomly assigned to one of two groups. The Actívatexto group receives a text messaging program encouraging both quitting smoking and physical activity, wearable devices to track physical activity, nicotine replacement therapies, and an online dashboard for data management. The Decídetexto group receives a text messaging program focused only on smoking cessation, nicotine replacement therapies, and a similar online dashboard. All participants are provided with nicotine replacement therapies and a Fitbit Versa 4 device to monitor activity. Throughout the study, participants complete assessments at the start, and follow-up visits at three and six months. Researchers verify smoking abstinence using cotinine tests and collect self-reported smoking status. Physical activity is tracked via wearable devices, and all data from text messages and devices are managed through an online system. The study monitors participants over six months to measure smoking cessation success and physical activity improvements.

Researchers are studying a culturally and gender-relevant tobacco cessation program designed for low-income Brazilian women. This program builds on prior successful Community Health Worker (CHW) interventions and integrates mobile health (mHealth) support through an interactive app. The goal is to evaluate if this combined CHW and mHealth approach can improve quitting rates compared to the existing tobacco cessation program offered by the public health system. The study has two phases. In phase I, the tobacco cessation program will be adapted and tested for feasibility with input from participants and stakeholders. Phase II involves a group randomized trial with eight towns and 344 women participants. One group receives the integrated CHW-mHealth intervention plus the standard public health tobacco cessation program, while the comparison group receives a home visit from a CHW who schedules attendance at the tobacco cessation program. Participants will be followed for at least six months, during which researchers will measure tobacco abstinence defined as no cigarette use in the past seven days. Abstinence will be verified by self-report and confirmed with exhaled carbon monoxide tests in about 30% of participants. The study will assess the effectiveness of the integrated program and may offer a model for tobacco cessation interventions in low-resource areas. The total participation time includes the initial adaptation phase and the randomized trial period.

Researchers are evaluating a culturally aligned digital smoking cessation program designed specifically for American Indian and Alaska Native persons who smoke. This randomized controlled trial compares this culturally tailored resource to a general, standard smoking cessation text messaging program. The study aims to examine the effectiveness of these programs in helping participants quit smoking combustible tobacco products. Participants will be randomly assigned to one of two groups: one receiving the culturally aligned smoking cessation text message program and the other receiving the standard text message program. Both groups will use their assigned program for six months. The study includes surveys at the start and at 1, 3, and 6 months to gather information about program use and smoking behavior. Additionally, carbon monoxide levels in exhaled breath will be measured at 1, 3, and 6 months using a specialized device to biochemically confirm smoking abstinence. During the study, participants will complete questionnaires about their smoking habits and program usage. Researchers will track smoking abstinence rates confirmed by breath tests after six months as the main outcome. Secondary measures include abstinence rates at earlier time points, self-reported quit attempts, cigarette use, and use of nicotine replacement or other support methods. Participation lasts for six months, with ongoing monitoring through surveys and breath tests to assess quitting success and program engagement.

Researchers are evaluating a smartphone-based intervention designed to help pregnant smokers quit smoking by using an app combined with peer support. The project aims to develop, implement, and test the feasibility and effectiveness of the SFT 2.0 app, which uses deep tailoring, reinforcement learning, and motivational interviewing counseling techniques. The study also seeks to build mobile health research capacity in Romania and improve support for smoking cessation during pregnancy and postpartum periods. The trial has three study groups: one group uses the SFT 2.0 app and receives a fixed number of four counseling video sessions during pregnancy up to one month postpartum; another group uses an adaptive version of the app with as-needed counseling sessions ranging from one to ten during the same period; and a control group receives low-dose counseling with one prenatal and one postnatal session. Both experimental groups involve use of the app by pregnant smokers and their nominated support persons. Participants will be involved for a period covering pregnancy through postpartum, with evaluations of smoking cessation and abstinence conducted at three and six months after birth. Researchers will assess outcomes such as reach, adoption, implementation, and user engagement one month after birth. The trial is randomized and double-blinded, with assessments including video counseling and app usage data to measure effectiveness and feasibility of the intervention.