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193 active trials for Smoking Cessation

The ESTxENDS Trial: Pulmonary Function Substudy

Cigarette smoking is the leading cause of preventable death in Switzerland and still more than a quarter of the Swiss population smokes cigarettes. Recently, electronic nicotine delivery systems (ENDS; also called vaporizer, e-cigarette or electronic cigarette) have become popular with smokers who want to stop smoking or reduce their exposure to inhaled chemicals since ENDS use appears to be safer than tobacco smoking. The inhaled ENDS aerosol appears safe in laboratory conditions, its long-term effects on pulmonary function remains unknown. This study will therefore investigate the impact of ENDS on lung function in smokers, who attempt to quit using ENDS compared with smokers, receiving only smoking cessation counseling with nicotine replacement therapy (NRT). Multiple breath washout (MBW) is an established technique for assessment of peripheral airway function in pediatrics and its use is emerging in adult medicine, as it offers a better sensitivity to assess small airway disease before large airway involvement can be detected using conventional pulmonary function tests (PFT - spirometry, body plethysmography and diffusing capacity test). Preliminary evidence from limited studies suggest MBW parameters (LCI, Scond, Sacin) can be impaired in smokers with normal lung function and improve after smoking abstinence. Primary objective of this substudy is to assess changes in LCI from baseline to 6 months post target quit date (TQD) in cigarette smokers randomized to the intervention group compared to the control group. For this trial, cigarette smokers motivated to quit smoking cigarettes will be included. Participants in the intervention group will receive an ENDS and nicotine-containing e-liquids, which they will be allowed to use ad libitum. Additionally, they will receive standard of care, i.e. smoking cessation counseling and encouragement to use NRT. Smoking cessation counseling will be provided in person at the first clinical visit and then over the phone at the target quit date and again at week 1, 2, 4 and 8 after the target quit date. Participants in the control group will receive only standard of care. All participants will be followed over a 6-month period. After 6 months, participants will be asked to come to a final clinical visit.

Start: April 2019

ESTxENDS Trial- Oxidative Stress Induced by Electronic Nicotine Delivery Systems (ENDS/Vaporizer/E-cig) Measured in EBC

Cigarette smoking is the leading cause of preventable death in Switzerland and still more than a quarter of the Swiss population smokes cigarettes. Recently, electronic nicotine delivery systems (ENDS; also called vaporizer or electronic cigarette) have become popular with smokers who want to stop smoking or reduce their exposure to inhaled chemicals since ENDS use appears to be safer than tobacco smoking. Smoking induces inflammation leading to acute and chronic oxidative stress, both evidenced in in vitro and in vivo studies. Tobacco-smoke contains free reactive radicals that generate reactive oxygen species (ROS). Afterwards ROS in turn induce oxidative stress, which likely plays a key role in causing airways and related pathologies linked to tobacco-smoke exposure. Acute and chronic oxidative stress can be measured by quantifying two biomarkers in exhaled breath condensates: 8-iso-prostaglandin F2? (8-isoprostane) and 8-Oxo-2'-deoxyguanosine (8-OHdG). 8-isoprostane, a marker of lipoperoxidation, results mainly from the non-enzymatic action of free radical attack on arachidonic fatty acids. 8-OHdG is a marker of DNA oxidation caused by ROS, and a predictor of lung cancer. Oxidative stress between smokers who quit (with or without ENDS) and those who use ENDS for a long time have not yet been assessed in the setting of a randomized controlled trial (RCT). This study will therefore test the efficacy of ENDS for cigarette smoking cessation, the safety of ENDS on adverse events, the exposure to inhaled chemicals and the effect of ENDS on health-related outcomes, in particular by measuring oxidative stress in exhaled breath condensates (EBC). For this trial, cigarette smokers motivated to quit smoking cigarettes will be included. Participants in the intervention group will receive an ENDS and nicotine-containing e-liquids, which they will be allowed to use ad libitum. Additionally, they will receive smoking cessation counseling. Participants in the control group will receive smoking cessation counseling only. All participants will be followed over a 6-month period. Measures of oxidative stress by means of exhaled breath condensates and urine samples will be assessed at baseline and at 6- months' follow-up by asking to breathe for 20 minutes in a vial kept frozen at -10°C to collect around 2 mL of EBC.

Start: April 2019

Construal Level as a Novel Pathway for Affect Regulation and Cancer Control

The objective of the proposed research is to conduct a longitudinal experiment on the neurocognitive pathways and individual differences in high-level construal for affect regulation and smoking cessation. The population is adult smokers aged 25-55 who have tried and failed to quit multiple times and who are experiencing poverty. The primary endpoints are (a) the similarity in neural representation of high-level construal to one of two candidate pathways, (b) the presence of meaningful individual differences in the neural representation of high-level construal, and (c) as a secondary endpoint, the effect size of the high-level construal condition (relative to treatment-as-usual) on smoking as measured by cigarettes per day. Each of these endpoints corresponds to a specific null hypothesis. The null hypothesis for the first endpoint is that high-level construal is not significantly different in its neural representation from down-regulation of craving, which would suggest that high-level construal does not operate through distinct mechanisms from traditional treatments. The null hypothesis for the second endpoint is that the between-subjects variability in the neural representation of construal level does not significantly relate to relevant individual differences measures (e.g., traits, task behavior), which would suggest that individual differences are not meaningfully related to outcomes. Finally, the null hypothesis for the secondary endpoint is that the magnitude of the effect of high-level construal on smoking as measured by reductions in average cigarettes per day is not significantly greater than in TAU, which would suggest that the efficacy of the high-level construal condition is not significantly greater than a standard text-messaging intervention. The primary endpoints will be assessed at baseline and change from pre-to-post training (8 weeks).

Start: May 2021

Personalized Smoking Cessation Infographic in COPD

This study assesses the effect of a personalized smoking cessation infographic on physician smoking cessation counseling rates and smoking cessation pharmacotherapy prescription rates. The study assesses the difference in physician behaviour using a one-year pre (control arm) vs. one-year post (intervention arm) trial period. General practitioners, nurse practitioners and respirologists who refer eligible patients (COPD, active smoking) for spirometry at the St. Michael's Hospital, Toronto Western Hospital, Women's College Hospital and Sunnybrook Hospital Pulmonary Function Labs will receive the infographic. This is a quality improvement initiative. The smoking cessation infographic uses individualized patient data (height, weight, sex, baseline FEV1, etc.) to produce a personalized lung function decline prediction over the next 15 years.

Start: January 2022

Couples Dynamics and Smoking Cessation

This study is about investigating smoking and attempts to quit smoking in couples. Participation will help determine better treatment efforts for couples who want to quit smoking. All study procedures will be conducted remotely, allowing couples to interact with study personnel through zoom.

Start: August 2018

A Multi Doses Study to Compare the Pharmacokinetics of BR9003A and BR9003 in Healthy Adult Subjects

This is a randomized, multiple doses, crossover clinical study to compare the pharmacokinetic characteristics and the safety between administration of BR9003 and BR9003A in healthy adult subjects. Within each period, randomized subjects will be taken 2 dosing regimens of administrating BR9003 once a day for six days or BR9003A twice a day for six days.

Start: March 2021

Personalized Intervention Program: Tobacco Treatment for Patients at Risk for Lung Cancer (PIP)

The purpose of this study is to test the efficacy of two separate, sequential interventions to promote tobacco cessation/reduction in patients who are screened for lung cancer or are eligible for lung cancer screening. Each intervention will be compared to standard of care. The first intervention will be a personalized message intervention, the second intervention will consist of a biofeedback-based intervention.

Start: January 2016

Daily Liraglutide for Nicotine Dependence

This clinical research trial examines the effects of the GLP-1 receptor agonist liraglutide on smoking behavior, food intake, and weight gain. In this double-blind, placebo-controlled, parallel arm pilot study, overweight and obese smokers (N=40; 20 female and 20 male) will be randomized to 32 weeks of liraglutide or placebo and undergo 8 sessions of smoking cessation behavioral counseling. Outcomes are smoking abstinence and weight change.

Start: November 2018

Smoking by IV Pulsed Nicotine

To establish a dose-effect curve for nicotine's abuse potential as a function of nicotine dose and delivery rate. Pulsed IV nicotine administration will be used as it closely matches nicotine delivery by inhaled tobacco use.

Start: November 2019

Implementation and Dissemination of an Evidence-Based Tobacco Product Use Prevention Videogame Intervention With Adolescents

To examine the effects on participants who play the smokeSCREEN game in that the game will have positive changes in their attitudes, beliefs, knowledge, intentions, behaviors and other outcomes related to smoking and tobacco products.

Start: February 2019

Effectiveness of the Evaluation and Communication of "Pulmonary Age" as Help for Smoking Cessation

The experimental design is a cluster randomized trial in 2 parallel groups: an intervention group with assessment of the pulmonary age and a control group without. The population studied is patients aged 25 or more, smoking for more than a year, seen in general practice consultation, for any reason. The progress of the study will be composed of an inclusion visit (M0) with a pulmonary age estimation for the intervention group and an measurement of the exhaled carbon monoxide for both groups, then a follow-up visit 6 months after the inclusion (M6) with an exhaled carbon monoxide measure for both groups, and a phone call at 12 months (M12) with a quality of life survey for both groups. The primary outcome is the smoking cessation at 6 months, confirmed by the carbon monoxide exhaled, at a scheduled consultation with the General practitioner (GP).

Start: November 2021

Nurse-led Smoking Cessation With Further Follow-up in Lifestyle Centres - a Randomized Pilot Study

The purpose of this randomized controlled pilot study is to test whether an in-hospital nurse-led smoking cessation intervention increases the refferal rate to healty life-centers in the municipalities. We will also describe the proportion who succeed in quitting smoking between the intervention group and the control group and obtain new knowledge about the patient and system factors of importance for participation to healty life-centers and for successful and unsuccessful smoking cessation.

Start: February 2021

Smoking Cessation Programme in Workplaces in Hong Kong (Phase ?)

Smoking causes cardiovascular and respiratory diseases, cancers and diabetes, and it has been a leading risk factor for death globally. Despite the availability of smoking cessation services locally, most smokers do not use such services. Workplace is one of the most convenient platforms to provide smoking cessation services and over 55% of smokers are employed according to the local population-based survey. Moreover, The COVID-19 pandemic and new normal increase in mental health burden to people in the workplace. An online survey during the pandemic found 88% of Hong Kong employees suffered from stress at work during the past 7 days. Mental health can be both precursors and consequences of smoking. However, the effectiveness of a smoking cessation programme conducted in workplace is yet to be examined in Hong Kong, and the mental health support for smoking employees in promoting smoking cessation is not clear. Thus, this study aims to test, by a 2-arm RCT, the effectiveness of an intervention of which includes mobile phone-based intervention on reducing mental health symptoms and smoking cessation in workplaces in Hong Kong; identify facilitators and barriers of successful policy implementation and quitting; examine and evaluate the company environment and their policies in promoting smoking cessation.

Start: April 2021

A Study to Compare the Pharmacokinetics of BR9003A and BR9003 in Healthy Adult Subjects

The purpose of this study is to evaluate the pharmacokinetics and safety of oral administration of BR9003 compared with BR9003A in healthy adult subjects

Start: March 2021

Systematic Screening for COPD in Tabacology Consultation

COPD is a very common disease, an estimated 3 million people are affected in France. Unfortunately, this pathology is under-diagnosed. Several reasons can be mentioned: the banality of the symptoms or the several comorbidities. Screening faces a major difficulty: the realization of a spirometry. Various studies have shown the complexity of the implementation of mass screening in cities by mini-spirometry. The COPD World Health Days allow this mass screening but without visibility on the actual entry into a care pathway. The objective of this study is to assess the impact of systematic screening for COPD during a tabacology consultation

Start: May 2021

Tobacco Cessation Among Smokers Under Alcohol and/or Cannabis Treatment

Aims: To identify the predictors associated with smoking cessation in smokers under treatment for alcohol and/or cannabis treated in drug treatment centers (DTC). Methodology: Mixed methods project with qualitative and quantitative designs (three studies). Study I discussion groups: of clinical professionals of DTC to explore the barriers/facilitators of these smokers in quitting and the interventions carried out. Study II Prospective cohort of smokers in alcohol and/or cannabis treatment that will be followed-up for 12 months. Sample size: difference in incidence (exposed to cessation interventions versus non-exposed = 12 per 100 years), ? = 0.05, ? = 0.10, losses = 20% (n = 726). Dependent variables: self-reported and verified tobacco consumption abstinence, quit attempts, motivation, and self-efficacy. Independent variables: age, sex, the substance under treatment. Analysis: incidence, relative risk and simple and multiple logistic regression models (odds ratio and confidence interval, CI, 95%) of quitting. Study III discussion groups: with smokers under alcohol and/or cannabis treatment selected according to their typology. Analysis: of thematic content and triangulation qualitative and quantitative results. Expected results: Characterization of variables that influence tobacco cessation, to improve the design of interventions.

Start: October 2020

Veteran Support for Smoking Cessation Pilot Project (VAntage Pilot)

This is a proposal to conduct a pilot study to assess the feasibility of recruitment of Veteran smoker and support person (SP) dyads and study procedures in preparation for a large randomized pragmatic trial.

Start: April 2021

Using Machine Learning to Develop Just-in-Time Adaptive Interventions for Smoking Cessation

The purpose of this study is to evaluate the feasibility and preliminary effectiveness of delivering a personalized, just-in-time adaptive intervention driven by machine learning prediction of smoking lapse risk in real time.

Start: September 2021

Impact of Primary Care COPD Screening Strategies on the Smoking Cessation Process (DISCO-SET)

The general practitioner is confronted with unselected smokers whose attempts to quit smoking are often repeated over time before leading to a definitive cessation. Each year, 3-5% of smokers succeed in quitting in the general population. The corollary is that the majority of smokers are in a situation of failure in their attempt to quit: 33% declared during the 2019 French Health Barometer to have made an attempt of at least 7 days in the past year. Thus, this status of "smoker" can cover a wide variety of situations: no attempt to stop smoking, attempt(s) of more or less clinical significance, previous support or not by a health professional, etc. Currently, the HAS recommendations do not determine a specific course of action for these smokers, whose experiences may be very different. It could therefore be interesting to objectivize the smoking cessation process of these patients who have or have not succeeded in quitting, in order to deduce profiles of smokers according to their previous smoking cessation experiences. Furthermore, the choice and relevance of the cessation criteria used are debated. Following the randomized controlled trial DISCO on COPD screening interventions in primary care (3 intervention arms, 1 control arm), we will carry out a pilot cross-sectional survey on the cessation process of smokers during the 2 years following their participation, evaluating the incidence and modalities of cessation attempts of smokers belonging to an age group at risk of COPD (40-80 years) and who initially consulted their general practitioner for any reason 2 years ago at the time of their inclusion. The impact on future management could be the personalization of cessation advice given to smokers according to quantitative and qualitative indicators specific to their experience, their previous history of smoking cessation, their health situation and socio-demographic characteristics. Eventually, a gradation of the levels of support offered to patients in general practice on the basis of predictive factors of smoking cessation could be studied. We hypothesize that participation in COPD screening with the GP may be associated with patient progress in quitting smoking. This pilot study will be conducted on a random sample of 120 patients from the subgroup of 544 patients who were smokers at inclusion in DISCO.

Start: April 2021

AR Enhanced Pictorial Warnings on Smoking Cessation

This pilot randomized controlled trail aims to test the effects of AR enhanced pictorial effects in harms of smoking and benefit of smoking cessation.

Start: April 2021