Smokers

Smoking negatively affects many organs and gradually worsens health, especially lung function. It causes mild airway obstruction and slows lung growth, impacting breathing and overall quality of life. This study evaluates balloon-blowing exercises combined with abdominal and lumbar core muscle activation positions to see if they can improve lung function and quality of life in smokers. Participants will be randomly assigned to one of two groups: one will perform balloon-blowing exercises with abdominal and lumbar core muscle activation three times a week for four weeks, supervised by a physical therapist. The other group will perform diaphragmatic breathing exercises with the same frequency and duration. Both interventions last four weeks, with measurements taken before and after. Participants will undergo evaluations of lung function including forced vital capacity (FVC), forced expiratory volume in one second (FEV1), peak expiratory flow (PEF), dyspnea levels, oxygen saturation, and quality of life assessments. These measures will be collected at the start and end of the four-week period to monitor changes and effects of the exercises on respiratory health.

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.

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 efficacy and safety of brenipatide compared to a placebo for helping adults who have recently quit smoking avoid relapse. This phase 2, multicenter, randomized, double-blind study focuses on reducing the risk of returning to cigarette smoking. The study is sponsored by Eli Lilly and Company and involves participants aged 18 to 75 years who are motivated to stay quit from smoking. Participants will receive either brenipatide or a placebo, both administered by subcutaneous injections. The study includes a 2-week screening period, followed by a 24-week treatment period where participants self-inject the study drug or placebo. After treatment, there is an 8-week safety follow-up to monitor participants. The study involves up to 17 visits during the 34 weeks of participation. During the study, researchers will measure the percentage of participants who maintain continuous abstinence from smoking confirmed by carbon monoxide testing from week 1 to week 24, allowing for slips. Additional assessments include patient-reported outcomes, changes in body weight, pharmacokinetic measurements of brenipatide, and detection of anti-drug antibodies. Participants need to be reliable in attending visits and following study procedures, including self-injection. Safety monitoring continues throughout the follow-up period.

Researchers are evaluating the feasibility of an anti-aging intervention combining an exercise regimen, spermidine supplementation, and either lamivudine or rapamycin in adults aged 65 to 80 years who are current or former smokers. This Phase 1b clinical trial aims to assess safety and the impact of these interventions on systemic inflammation and aging-related changes. Participants will be randomly assigned to one of two groups: one group will perform an exercise regimen and take spermidine along with lamivudine for 180 days, while the other group will perform the same exercise regimen and take spermidine with rapamycin for 180 days. The exercise program includes high-intensity interval training twice a week and resistance training three times a week. Spermidine is given orally at 2 mg per day. During the study, researchers will monitor participants for adverse events and their ability to complete more than 80% of the pharmacological intervention. They will also measure inflammation markers like the neutrophil to lymphocyte ratio at 180 days. Safety and feasibility will be closely observed, with the total participation lasting about six months.

Researchers are studying patients with unruptured intracranial aneurysms to understand the relationship between cotinine levels and aneurysm wall enhancement seen on high-resolution magnetic resonance imaging (HRMRI). This observational study aims to explore how these imaging features and cotinine levels might relate to the risk of aneurysm rupture and patient outcomes. The research includes following patients' prognosis and aneurysm occlusion rates to better understand this connection. Participants undergo high-resolution magnetic resonance angiography to detect and classify the presence or absence of aneurysm wall enhancement. Blood or urine samples are collected for cotinine testing, which relates to smoking exposure. Patients are grouped based on whether their aneurysm wall shows enhancement on HRMRI. The study follows patients for at least one year to observe imaging features, functional outcomes measured by the modified Rankin Scale (mRS), and aneurysm occlusion rates. During the study, participants will have imaging and clinical assessments at baseline and follow-up visits according to the research protocol. Researchers will monitor aneurysm features on HRMRI, patient functional status at 12 months, and aneurysm occlusion status after treatment. Participants will also provide samples for cotinine analysis. The study is expected to last until March 2027, with ongoing follow-up to evaluate correlations between imaging findings, cotinine levels, and patient outcomes.

Researchers are investigating how the availability of different flavors in electronic nicotine delivery systems (ENDS) affects smoking abstinence among adult smokers of combustible cigarettes. This open-label, randomized controlled trial focuses on healthy adults aged 21 to 65 who currently use combustible cigarettes. The study aims to assess whether access to tobacco-flavored, menthol-flavored, mint, or other flavored e-liquids influences participants' ability to stop smoking their usual cigarettes over a 13-week period. Participants will be randomly assigned to one of three groups with varying flavor options: one group can choose tobacco and two non-tobacco/non-menthol/mint flavors, another can choose tobacco, mint, and menthol flavors, and the last group will have access only to tobacco flavor. All groups will use an ENDS device with a 5% nicotine level. The study starts with a one-week trial period for flavor sampling, followed by regular visits on Days 0, 30, 60, and 90. Some groups have optional visits in the first 4 weeks to try different flavors within their assigned options. Participants can use the ENDS and any other tobacco or nicotine products as they wish during the study. Participants will complete daily, weekly, and monthly surveys via a smartphone app, reporting cigarette use, flavor preferences, product satisfaction, quit attempts, and other factors influencing their smoking habits. The ENDS device will record usage patterns such as puff duration and intervals. Safety and adverse events will be monitored through a hotline throughout the study. The primary outcome is smoking abstinence during the final 7 days of the 13-week period. After study completion, participants return for a close-out visit and are discharged from the study.

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.