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NCT07466875
The goal of this clinical trial is to evaluate the feasibility and preliminary effectiveness of auricular acupressure (ear seeds) combined with nicotine replacement therapy (NRT) in psychiatric inpatients (both male and female, aged 18-65) who are forced to abstain from smoking due to the smoke-free environment of the inpatient ward. The main questions it aims to answer are: * Does auricular acupressure significantly reduce the severity of nicotine withdrawal symptoms compared to standard care? * Can auricular acupressure effectively lower nicotine craving and anxiety levels in patients during their mandatory abstinence? Researchers will compare the experimental group (NRT plus active auricular acupressure) to a control group (NRT plus sham auricular acupressure) to see if the addition of ear point stimulation provides better relief for withdrawal distress. Participants will: * Receive standard nicotine replacement therapy (NRT) as prescribed by their physician. * Be randomly assigned to receive either Vaccaria segetalis seeds or sham materials on specific ear acupuncture points. * Be instructed to press the beads 3 times daily to stimulate the points for a period of 4 weeks. * Complete standardized assessments (MNWS, HAMA, and craving scales) at baseline and multiple time points during the intervention.
NCT01867411
Background: \- Smoking is a difficult habit to quit, and some people find it more difficult to quit than others do. Nicotine is the substance in cigarettes that makes smoking so addictive. Nicotine changes some patterns of brain activity, and smokers have differences in brain activity when compared to non-smokers. Some genes make it more likely that a person will become addicted to smoking. Researchers want to study how nicotine interacts with genes and brain activity. This may help develop better treatments to help people quit smoking. Objectives: \- To develop a test of nicotine dependence, using brain activity and genetic analysis, which may be useful in predicting success in smoking cessation and in the development of new smoking cessation treatment targets. Eligibility: * Main group: Current smokers between 18 and 55 years of age who are seeking treatment to quit. * Comparison group: Current smokers between 18 and 55 years of age who are not seeking to quit. * Comparison group: Healthy former smokers between 18 and 55 years of age. * Comparison group: Healthy nonsmoking volunteers between 18 and 55 years of age. Design: * Participants will be screened with a physical exam and medical history. Blood samples will be collected. * The three comparison groups will have one magnetic resonance imaging (MRI) scan session. They will have tests of thinking, concentration, and memory both inside the scanner, and while sitting in front of a computer. * Current smokers who are trying to quit must be willing to undergo a course of nicotine treatment that includes weekly counseling (for 12 weeks) and e-cigarettes. Participants will attempt smoking abstinence and will have a total of 6 MRI scanning sessions. They will do thinking, concentration, and memory tasks inside and outside of the scanner. * For smokers, the first scanning session will take place before they attempt to quit. This will be a baseline scan. The second scanning session will take place 48 hours after having their last real cigarette. After this scan, they will use electronic cigarettes to help quit their habit. * After using e-cigarettes for two weeks, smokers will have a third scan session.. They will then gradually taper their use of the electronic cigarettes over the course of three weeks, at which point they will be nicotine abstinent. * After about 5 weeks of abstinence, they will have the fourth scan. The fifth scan will be approximately 6 months after start of the study, and the final scan will take place at about 1 year from the study start. * Smokers will continue to receive support on quitting smoking until the study ends at about 1 year.
NCT02974582
Background: Smoking is a major public health problem in the U.S. Almost a half a million Americans die from it in a year. One thing that contributes to why people smoke is the marketing of cigarettes. Cigarette direct mail marketing usually targets young smokers of lower socioeconomic status. Researchers want to find out more about how this kind of marketing influences smoking behavior in young people from different socioeconomic levels. Objectives: To study the effects of cigarette direct mail marketing on beliefs, responses, and arousal. To study how these things may differ among young adult smokers of high and low socioeconomic status. Eligibility: Volunteer adults ages 18 to 29 who smoke. Design: Participants will have 1 visit. Participants will be asked questions about their health and recent smoking. A nurse will check their vital signs. Participants will have a simple eye exam. They will give blood and urine samples. Participants will be connected to equipment. This will collect data while they look at pictures. Then they will have a 10-minute break. A nurse will observe them during the break. Participants will have their breath analyzed. Participants will answer questions. The topics will include: Education Job Income Family history Tobacco use Exposure to pro-smoking and anti-smoking messages History of drug and alcohol use
NCT01036581
Background: \- Functional and structural magnetic resonance imaging (MRI) techniques have allowed researchers to map and study how the brain works when at rest and when engaged in specific tasks. MRI scans have provided more information about how drugs affect the brain, and about how drug addiction changes the brain and influences behavior, mood, and thinking processes. To better understand the underlying mechanism of drug addiction and to develop strategies for more effective treatment, researchers are interested in developing new MRI techniques to study the effects of addiction on the brain. Objectives: \- To develop new functional and structural MRI techniques, and to evaluate their potential use in brain imaging studies related to addiction. Eligibility: * Individuals between 18 and 80 years of age. * Participants may be smokers or nonsmokers, and may use drugs or not use drugs. Design: * During the initial screening, participants will complete questionnaires about family and personal history, drug use, and other information as required by the researchers. Participants who will be asked to complete tasks during the MRI scan will be shown how to perform these tasks before the scanning session. * Before each study session, participants may be asked to complete some or all of the following: questions about their drug use during the last week, a breathalyzer test, a urine drug-use assessment, a urine pregnancy test, or a measure of carbon monoxide. Participants will also provide blood samples before the start of the scan. * For each scanning session, participants will have an MRI scan that will last approximately 2 hours. * MRI scans may include specific tasks to be performed during the scan, or an experiment that studies the brain's response to carbon dioxide....
NCT06909500
This clinical trial evaluates a smartphone application (app) called Acceptance and Commitment Therapy (ACT) on Vaping for helping young adults quit using electronic cigarettes (e-cigarettes). E-cigarettes pose numerous risks, particularly to youth and young adults. Addressing the high prevalence of e-cigarette use by young adults requires effective and accessible treatments to support current users to quit. Research shows this group prefers and benefits from newer methods of treatment delivery such as digital interventions. ACT on Vaping is a digital therapeutic intended to deliver behavioral therapy to young adults who vape to motivate and support abstinence from all nicotine and tobacco products. The app contains sessions that promote awareness of cues that trigger tobacco use and teach skills for responding to these triggers in a way that is tailored for the participant's readiness to quit. Receiving access to the ACT on Vaping app may be effective in helping young adults quit vaping.
NCT06965296
The goal of this quasi-experimental study is to test if a smartphone app can help adolescents aged 14-20 quit e-cigarettes. The main questions it aims to answer are: * Can the app help adolescents manage cravings and increase their readiness to quit? * Does the personalized and real-time support provided by the app improve their success in quitting e-cigarettes? Researchers will compare two groups: an immediate-intervention group that starts using the app right away and a delayed-intervention group that begins after three months, to see if the timing of app access influences outcomes in e-cigarette cessation. Participants will: * Set personal goals and track their daily progress within the app. * Use a real-time "urge" feature that provides immediate support during cravings. * Engage with a chatbot for quick answers and motivational support around quitting. This study aims to create an accessible, personalized tool to help adolescents reduce or quit e-cigarette use, exploring its feasibility as a broader intervention model.
NCT07398976
This study examines differences between males and females in the appeal and addiction potential of menthol flavored e-cigarettes with and without nicotine.
NCT06295757
Characterize effects of relighting on smoke toxicant deliveries and subjective smoking measures. This will be a within-subject comparison in a single experimental group of 30 smokers who report engaging in relighting behaviors. We will assess smoking intensity for relit and non-relit (i.e., smoked continuously without relighting) cigarettes in the natural environment and will conduct in-clinic measurements of smoking topography and subjective responses for relit and non-relit cigarettes. Information on relighting patterns and smoking topography collected from each participant will be used to compare machine-measured smoke yields of key harmful constituents when their usual cigarettes are smoked with and without relighting. Hypothesis: Relit cigarettes will produce higher levels of toxicants than non-relit cigarettes.
NCT07366294
The goal of this clinical trial is to learn whether lemongrass (Cymbopogon citratus) inhaler and liquid vapor interventions affect nicotine dependence and related biological and behavioral outcomes in adult smokers. The study will also evaluate changes in blood biomarkers, psychological well-being, and lifestyle-related measures. The main questions it aims to answer are: * Do lemongrass inhalers and/or liquid vapor reduce nicotine dependence and cotinine levels in adult smokers? * How do these interventions affect blood lipid profile and biomarkers of inflammation, oxidative stress, endothelial function, and stress response, including interleukin-6 (IL-6), malondialdehyde (MDA), superoxide dismutase (SOD), nitric oxide (NO), cortisol, and nicotinic acetylcholine receptors (nAChRs)? * Do lemongrass inhaler and liquid vapor influence appetite, physical fitness, sleep quality, and psychological status measured using the Depression, Anxiety, and Stress Scale (DASS)? Researchers will compare participants receiving lemongrass inhaler, lemongrass liquid vapor, or a combination of both to a control group receiving no intervention to evaluate the effects of the interventions. Participants will: * Receive a lemongrass inhaler, lemongrass liquid vapor, a combination of both, or no intervention according to group assignment * Continue their usual daily activities during the study period * Provide blood samples and complete questionnaires to assess biochemical markers, nicotine dependence, appetite, fitness level, sleep quality, and psychological status
NCT06472869
This study investigates the feasibility, acceptability, and short-term effects of providing 4 weeks of complimentary electronic cigarettes (ECs) to 30 individuals who did not quit after smoking cessation treatment provided in the context of lung cancer screening and do not plan to quit smoking. This open-label single-arm pilot clinical trial will test the impact of EC provision on: 1) study feasibility, 2) EC acceptability, 3) tobacco use behavior (e.g., cigarettes per day, EC use), and 4) biomarkers (e.g., carbon monoxide, cotinine, and anabasine). Participants will be asked to switch from combustible cigarettes to the NJOY ACE 5% nicotine electronic cigarette (EC) for 4 weeks. They will be followed an additional 4 weeks after EC provision ends (to 8 weeks). The first study hypothesis is that more than 40% of eligible smokers who are offered participation in the trial will enroll, and that 75% of enrollees will complete the trial. The second study hypothesis is that participants will report fewer cigarettes smoked per day at the end of 4 weeks of EC provision, relative to their baseline values.
NCT07040566
This is randomized, placebo-controlled clinical trial in treatment-seeking adults who report regular e-cigarette use to test the hypothesis that varenicline is efficacious for quitting e-cigarettes.
NCT06534047
Tobacco smoking is the leading preventable cause of morbidity and mortality worldwide. However, currently available treatments, including standard pharmacotherapy and behavioural support, are limited in their efficacy, tolerability, and acceptability by patients. Additionally, tobacco use is substantially higher in individuals with comorbid mental illness, constituting a particularly vulnerable population. As such, the development of multiple evidence-based treatments for smoking cessation is of upmost importance. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain-based approach in which alternating magnetic fields are applied to the scalp to induce electrical currents in cortical tissue. As it can modulate neural circuits implicated in neuropsychiatric disorders, it is a promising brain-based approach in the treatment of substance use disorders. Recently, a deep TMS coil has been cleared by the Food and Drug Administration (FDA) as efficacious for tobacco use disorder, representing the first rTMS indication for addictions. Before adoption of this intervention into smoking cessation clinics, it is important to investigate whether implementation of rTMS into clinical care is feasible, acceptable, and appropriate for patients receiving care for nicotine dependence. The objective of this study is to compare the effectiveness of rTMS versus treatment as usual for patients with psychiatric disorders seeking treatment for smoking cessation. Also, barriers to the implementation of rTMS in routine clinical care will be examined by speaking with patients and health care providers on their experience with rTMS.
NCT01182766
This research study aims to test whether topiramate (a drug that is being used for seizure) will help individuals who have problems with both alcohol and nicotine. The investigators believe that individuals taking topiramate will be more successful at abstaining from both alcohol and nicotine than individuals taking placebo.
NCT06765291
This study will test the hypothesis that the QuitVaping (QV) intervention and additional texting support will improve nicotine abstinence rates in adolescents as compared to Enhanced Usual Care (EUC: education about nicotine, vaping and addiction, advice to quit vaping, referral to TIQ texting support). Approximately 400 adolescents will be randomly assigned to one of two arms (1) QuitVaping intervention plus texting support to quit vaping and (2) EUC only.
NCT06798324
The goal of this clinical trial is to determine if active transcranial direct current stimulation (tDCS) plus varenicline is an effective, safe and accessible treatment option for smoking cessation. The main questions this trial aims to answer are: 1. Does active tDCS plus varenicline improve short-term and long-term smoking abstinence rates compared to sham tDCS plus varenicline? 2. Are the safety profiles between active tDCS plus varenicline and sham tDCS plus varenicline different? The tDCS treatment schedule includes 10 daily sessions for the first 2 weeks (M to F), followed by 5 single bi-weekly booster sessions for the remainder of the treatment period. Participants will come in-person for two follow-up sessions to assess smoking behaviour at 6- and 12-months post-treatment.
NCT04188873
This project will use the Multiphase Optimization Strategy (MOST) to guide the development of optimized treatment strategies for the two most effective smoking cessation medications (Combination Nicotine Replacement \[C-NRT\] and varenicline). The investigators will recruit daily smokers from primary care to participate in a fully crossed, 2x2x2x2 factorial experiment (N=608) that evaluates 4 different factors: 1) Medication Type (Varenicline vs. C-NRT), 2) Preparation Medication (4 Weeks vs. Standard), 3) Medication Duration (Extended \[24 weeks\] vs. Standard \[12 weeks\]); and 4) Counseling (Intensive vs. Minimal). Participants will complete assessments one week pre-quit and then assessments of smoking status, treatment use, side effects, potential treatment mechanisms (e.g., withdrawal, self-efficacy) during the first week post-target quit date (TQD) and at Weeks 2, 4, 12, 20, 26, and 52 post-target quit date. These data will be used to examine the main and interactive effects of these four factors on various outcomes, with biochemically confirmed 12-month abstinence serving as the primary outcome. These data will also be used to determine which factors and combinations of factors are most effective with regard to 12-month biochemically confirmed abstinence and cost, thereby identifying optimized varenicline and C-NRT treatments, with each developed to yield especially great benefit. These optimized treatments will then be tested in the Optimized Care Project. The investigators will also examine the relative effects of each medication on particular outcomes (e.g., 12-month abstinence).
NCT03083353
The proposed study represents a crucial and important stage in translating basic research to strategies for treating nicotine dependence. The investigation addresses an important public health issue by testing an intervention - informed by basic research - that may lead to a more effective and efficient treatment for smokers. The expected findings should provide initial effect size data for the addition of isradipine to an integrated psychosocial/behavioral and pharmacological smoking cessation intervention for smokers, and thus provide the necessary data for a large-scale follow-up trial.
NCT05665465
The purpose of this study is to evaluate how certain childhood experiences influences brain function and responses to nicotine exposure in a group of nonsmoking young adults. The investigators assess responses to nicotine exposure by giving participants a small amount of nicotine or placebo, and then asking them to answer questionnaires. The investigational drugs used in this study are a nicotine nasal spray (i.e., Nicotrol) and/or a nasal spray placebo (made of common kitchen ingredients, including a very tiny amount of pepper extract also called capsaicin). The investigators assess brain function through function magnetic resonance imaging (fMRI), which is a noninvasive procedure that uses a magnetic field to take pictures of your brain while you are performing certain tasks. This study will help us to learn more about why some childhood experiences (adverse childhood experiences, or ACEs) contribute to increased risk for smoking and other substance use.
NCT06862050
The overall purpose of this pilot study is to assess the feasibility and acceptability of an in-person faith-based intervention to help people stop tobacco use. The study will address use of different types of tobacco products, such as smoking combustible cigarettes, cigarillos and little filtered cigars, and using/vaping electronic nicotine delivery systems (vape pens, e-cigs, and JUUL). The intervention consists of 12 weekly meetings in which participants will go through BREATHE Free, a study guide curriculum designed to teach character strengths and promote resilience. This pilot research will provide information and practical lessons on how to improve Breathe Free implementation, increase engagement of the local people, and maximize their benefit. The main questions it aims to answer are: * Do participants find BREATHE Free curriculum acceptable, engaging and helpful to stop tobacco use? * Do participants who complete BREATHE Free curriculum smoke fewer cigarettes per day? Researchers will assign participants to either BREATHE Free curriculum or usual care. Participants will: * Be taught BREATHE Free curriculum or be given information and referral to tobacco quit line * BREATHE Free group will attend 12 group meetings held on the university campus * All participants will answer interview questions related to tobacco use, character strengths and resilience * Expired Carbon Monoxide (CO) will be assessed in all participants.
NCT05587361
This study is designed to investigate the effects of a beta-adrenergic antagonist (Propranolol; 40 mg IR) and nicotine patch (14 mg) administered alone and in combination on neurobiological and behavioral responses to smoking cues in ongoing cigarette smokers. This is a basic experimental study in humans and participants will not take these medications for an extended period or make a cessation attempt as part of their involvement in this research project.