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 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.

Researchers are evaluating the effect of providing access to two types of heated tobacco products HTP on smoking reduction and abstinence among healthy adult smokers aged 21 to 65 years in the United States. This multi-site, open-label study aims to assess how using HTP devices with different flavored stick variants influences smokers ability to stop or reduce combustible cigarette use over a 3-month period. The primary goal is to measure the rate of complete cigarette abstinence in the final seven days of the study. Participants are randomly assigned to one of two study groups one using a one-piece HTP device and the other using a two-piece HTP device. Each device group includes access to four stick variantstwo menthol and two tobacco flavorsunder the brand name virto. The study includes a 90-day actual use period where participants try all four stick variants during a 1-week product trial and then continue use as they choose. The interventions are designed to explore the impact of these devices and flavors on cigarette smoking habits. Throughout the study, participants complete questionnaires via a smartphone app and undergo assessments related to cigarette use and product preferences. Researchers track cigarette reduction, switching to HTP use, time to abstinence, and adverse events over the 3-month period. The primary outcome is self-reported abstinence from combustible cigarettes in the last 7 days of the study. Secondary measures include reduction in cigarette use by at least 50%, complete switching to HTP, and safety monitoring. The total study duration spans up to 3 months with ongoing data collection and follow-up.

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 evaluating the efficacy and safety of brenipatide compared to a placebo for reducing the risk of relapse to cigarette smoking in adults who have recently quit. The study is a phase 2, multicenter, randomized, double-blind trial focused on helping adults maintain abstinence from smoking. Participants are adults aged 18 to 75 years who have recently quit smoking and are motivated to stay quit. Participants are randomly assigned to receive either brenipatide or a placebo, both administered by subcutaneous injection. The study involves a 2-week screening period, followed by a 24-week treatment period where participants self-inject the assigned intervention. After treatment, there is an 8-week safety follow-up period to monitor participants health and any effects related to the study drug. Throughout the approximately 34-week study, participants are expected to attend up to 17 study visits. Researchers will measure the percentage of participants who achieve continuous abstinence from cigarette smoking, confirmed by carbon monoxide levels, from week 1 to week 24. Additional assessments include patient-reported outcomes, body weight changes, drug plasma concentration levels, and monitoring for anti-drug antibodies. Safety and adherence are closely monitored during and after the treatment phase.

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-tobacconon-mentholmint 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.