Smoking Cessation

Researchers are studying ways to improve treatment decisions for smokers who find it hard to quit using medications. This trial compares different approaches including nicotine replacement therapies patches and lozenges, varenicline, and harm reduction products like e-cigarettes. The goal is to find better strategies to help smokers quit by adjusting treatments based on early response. Participants will receive free treatment products for 12 weeks. Initially, they will be randomized to either varenicline or combination nicotine replacement therapy. After 4 weeks, based on their success in quitting, they may continue the same medication or switch to the other option. At 8 weeks, those still not successful may either continue their current medication or switch to e-cigarettes. No products are provided after 12 weeks. The study includes an additional survey at 6 months after the first phone call. All visits and assessments are done remotely, with a total of 8 surveys completed over the 6-month study period. Researchers will measure quitting success at 8 weeks as the primary outcome and assess dependence and longest quit attempt duration at 12 weeks. Participants are monitored through surveys without in-person visits, making participation convenient and accessible.

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 apps 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 Ketterings 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 investigating how vagal nerve stimulation VNS combined with nicotine replacement therapy NRT might help adults quit smoking. This study aims to provide early evidence on whether using VNS along with nicotine patches increases smoking abstinence rates over 12 weeks. It involves adult smokers motivated to stop smoking and evaluates a treatment approach for smoking cessation. Participants are randomly assigned to one of two groups. One group receives a handheld VNS device along with 21 mg nicotine patches and brief behavioral therapy using a self-help manual called Smoke Free and Living It. The VNS device delivers up to 30 electrical stimulations a day on the neck for 2 minutes each. The other group receives the nicotine patches and behavioral therapy without VNS, both for 12 weeks. During the study, participants attend regular visits and use the treatments daily while trying to stop smoking. Researchers assess smoking abstinence at 12 weeks as the main outcome. They monitor adherence to the interventions, smoking status, and any health effects. The total study duration includes the 12-week treatment period with ongoing evaluation of smoking cessation success and safety.

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 Actvatexto, a mobile intervention designed to help Latino adults who smoke quit smoking and increase their physical activity. This randomized controlled trial compares Actvatexto, which promotes both smoking cessation and physical activity, to Decdetexto, 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 Actvatexto 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 Decdetexto 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 evaluating a culturally- and gender-relevant tobacco cessation program designed for low-income Brazilian women. This program is delivered by Community Health Workers CHWs and is being adapted to incorporate mobile health mHealth support through an interactive app for participants and a tracking system for CHWs. The study aims to compare the effectiveness of this integrated CHW-mHealth intervention against the standard approach of scheduling participants to attend tobacco cessation programs at neighborhood public health clinics. The study has two phases. Phase I focuses on adapting the CHW-delivered tobacco cessation program to include mHealth support, testing its feasibility through assessments, pretesting, and pilot testing with stakeholders. Phase II involves a group randomized trial with eight towns and 344 participants, where one group receives the integrated CHW-mHealth intervention and the comparison group receives a home visit by a CHW with scheduling to attend the public health system program. Participants will be evaluated for tobacco use abstinence at 6 months, defined as no cigarette use in the past 7 days, verified by exhaled carbon monoxide in a subset of participants. Researchers will monitor participant engagement with the app and CHW interactions. The study is designed to assess the potential of this integrated approach as a model for tobacco cessation in low-resource settings, including rural and disadvantaged populations.

This research aims to develop and test a smartphone-based adaptive intervention to help adults aged 18 to 40 reduce smoking and cannabis use. The study focuses on tobacco use, a leading cause of preventable death in the United States, and evaluates a reinforcement learning RL algorithm designed to personalize treatment messages in real-time based on user context such as location and stress levels. This approach builds on previous work that showed feasibility in reducing smoking urges using cognitive-behavioral and mindfulness-based therapies delivered via smartphone. Participants first complete a 14-day training phase using a smartphone app that prompts them to answer surveys up to three times daily and passively collects GPS data. This data identifies high-risk locations and times, which inform the RL algorithm during a subsequent 30-day intervention phase. During this phase, the app delivers personalized messages based on cognitive-behavioral therapy, acceptance and commitment therapy, or attention control, triggered when participants enter designated high-risk areas. Throughout the 44-day study, participants smoking urges and cigarette use are assessed through surveys shortly after message delivery and at baseline and follow-up. Usability of the app is measured using the System Usability Scale at the end of the intervention. Additional outcomes include changes in stress, negative feelings, message helpfulness, activity completion, smoking abstinence, psychological flexibility, and tobacco product switching. The study monitors participants remotely using smartphone data and questionnaires to evaluate the interventions impact and user experience.