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193 active trials for Smoking Cessation

Cytisine Compared to Combination NRT in Relapsed Smokers

Cigarette smoking causes cardiovascular disease (CVD) yet many smokers with CVD are unable to quit despite strong desire to do so. Within 90 days of discharge, about 30% of smokers have returned to daily smoking and almost 60% have relapsed by 1 year. Patients with CVD who resume smoking are more likely to experience new events (e.g. heart attack or stroke) or die. New approaches are required. A new type of cessation product is a plant-based medication called Cytisine. Cytisine is taken orally over 25 days and reduces the pleasurable sensations that smokers get from cigarettes and reduces withdrawal symptoms. The primary research question is whether or not it is feasible to conduct a large-scale trial of the effectiveness of this product compared to conventional nicotine replacement therapy in smokers who have failed to quit using conventional methods. To determine feasibility, a pilot study will be conducted of sixty smokers (30 men, 30 women) with CVD who have been treated for smoking cessation but have relapsed within 90 days of discharge. Participants will complete a baseline assessment and will be randomly assigned to either the combination nicotine replacement therapy group (patch plus lozenge) or cytisine group. Participants will be treated for 25 days and then will return to UOHI so adherence to treatment and smoking status can be assessed. Feasibility of the larger trial will be based on: the recruitment rates; adherence to assigned treatments; dropout rates; and differences in 25-day quit rates between groups.

Start: September 2020

Engaging Sexual and Gender Minority Cigarette Smokers Into Social Media-based Treatment

This research study will evaluate the preliminary efficacy of Pride Posts Plus, a social media-based smoking cessation treatment. A pilot randomized trial (N=120) will compare Pride Posts Plus, which includes a gamification element, to Pride Posts (without gamification) and to a usual care treatment. Participants will be adults who smoke, identify as sexual or gender minorities, and use Facebook. The primary outcome will be biochemically verified 7-day abstinence from smoking at 3 and 6 months. Secondary outcomes will be treatment engagement, a quit attempt (y/n), and thoughts about tobacco abstinence at 3 and 6 mos.

Start: May 2020

Smoking Cessation Facilitated by Glucagon-like Peptide-1 (GLP-1) Analogues

Cigarette smoking is the leading preventable cause of premature death worldwide. However smoking is a very difficult addiction to break whereby main reasons for not quitting or relapsing after cessation are the nicotine withdrawal syndrome and post-cessational weight gain. GLP-1 analogues are well known to stimulate insulin secretion and to reduce energy intake and therefore body weight. Recent findings from animal and human studies suggest a role of GLP-1 in the pathophysiology of addiction. The putative role of GLP-1 analogues in nicotine reward regulation combined with its weight reducing effects might be of major interest in view of novel pharmacotherapeutic options for smoking cessation.

Start: June 2017

Goal2Quit + NRT Sampling

The goal of this work is to develop, systematically evaluate, and clinically test an integrated cessation intervention comprised of a depression-specific Behavioral Activation (BA) for cessation mobile app ("Goal2Quit") packaged with nicotine replacement therapy (NRT) sampling. This integrated intervention will address the need for an easily disseminable, evidence-based, depression-specific cessation intervention for delivery via primary care.

Start: June 2020

Understanding Risk Perception, Behaviour, and Attitudes Related to Other New Tobacco Products Among Youth

To understand the risk perception, behaviour, and attitudes related to electronic cigarettes and other tobacco products among youth.

Start: June 2020

'WeChat WeQuit' Smoking Cessation Program

This proposed (October 01, 2017 to December 31, 2018) project is to assess whether WeChat based interventions ('WeChat WeQuit') will be effective at helping people in China who smoke, to quit.

Start: August 2019

High Dose Bupropion for Smoking Cessation

This study aims to investigate the benefit of administering Bupropion XL (BUP-XL) to heavy smokers who also experience psychiatric symptoms.

Start: June 2020

Individualizing Pharmacotherapy for African American Smokers

Improving cessation outcomes for African American smokers through the use of novel, empirically-based strategies is a national health priority. In the vast majority of smoking cessation studies and in clinical practice, when smokers are provided a medication to help them quit, they are expected to continue that medication regardless of how well it is working. This study will assess whether African Americans smokers respond better if they continue with a single treatment or if their treatment is changed when that treatment is not working.

Start: May 2019

The Effects of I Quit Ordinary Smoking on the Arterial Wall and Endothelial Glycocalyx Properties of Smokers

I quit ordinary smoking (IQOS) is proposed as a bridge to smoking cessation. In this study the investigators will examine its effects on aortic elasticity, glycocalyx integrity, and exhaled carbon monoxide (CO) concentration, both acutely and after 1 month of use.

Start: March 2018

The Effects of Electronic Cigarette Smoking on the Arterial Wall and Endothelial Glycocalyx Properties of Smokers

Electronic cigarette is proposed as a bridge to smoking cessation. In this study we examine its effects on aortic elasticity, glycocalyx integrity, and exhaled carbon monoxide (CO) concentration and platelet function, both acutely and after 1 month of use.

Start: January 2017

Effect of Smoking Reduction on Endothelial Glucocalyx and Vascular Function

The integrity of endothelial glucocalyx plays a vital role in vascular permeability and inflammation. Smoking cessation is related with improved vascular function and is a key component of secondary cardiovascular prevention. Pharmacotherapy is a standard component of evidence based smoking cessation treatment. This study was designed to determine the effects medically-aided smoking cessation on glucocalyx thickness and arterial elasticity smoking cessation programs

Start: December 2014

Effect of Pre-op NRT on Peri-operative Complications and Long-term Abstinence: A Pilot Trial in Patients Undergoing CABG Surgery

This study will determine whether or not patients who use a Nicotine Replacement Therapy (NRT) patch prior to their by-pass surgery are more likely to be smoke-free 6 months after their surgery and have fewer post-operative complications

Start: October 2017

Smoking Cessation Treatment for Head & Neck Cancer Patients

This is Part 1 of a 2-part research study. The goal of this part of the study is to plan and test an investigational type of counseling called Acceptance and Commitment Therapy, for use in patients who have or had head and neck cancer, lung cancer, breast cancer, gastrointestinal cancer, or genitourinary cancer. This part of the study is also designed to train the study counselors how to perform Acceptance and Commitment Therapy. In this part of the study, participants will either receive Acceptance and Commitment Therapy or the standard type of counseling, called Motivational and Behavioral Counseling. This is Part 2 of a 2-part research study. In both parts of the study, participants receive either an investigational type of counseling (Acceptance and Commitment Therapy) or a standard type of counseling (Motivational and Behavioral Counseling). Part 1 was also designed to train the study counselors how to perform Acceptance and Commitment Therapy. The goal of Part 2 is to compare Acceptance and Commitment Therapy against Motivational and Behavioral Counseling. Researchers want to learn which type of counseling may be more effective in helping patients to stop smoking. These types of counseling will be tested in patients who have or had head and neck cancer, lung cancer, breast cancer, gastrointestinal cancer, or genitourinary cancer.

Start: March 2010

PRogetto Salute Parma

This project from the University Hospital of Parma (AOUPR) aims to verify the feasibility of a prevention program in our district, relying on advanced technological resources and highly experienced team in lung cancer early diagnosis, in order to identify useful elements towards the applicability of such a prevention program on a large scale (regional, national). Uncontrolled, monocentric experimental study with dynamic enrollment and prospective data collection, aimed at implementing a prevention program based on scientific evidence. This study is set to verify the applicability and feasibility of a lung cancer prevention program in a real context, including a preliminary evaluation at the smoking cessation clinic and a LDCT assessment with subsequent LDCT follow-up for participants who show indeterminate findings at the first LDCT (LDCT baseline) exam. The main objective of the study is to verify the feasibility of a lung cancer prevention program according to internationally validated scientific methods. Secondary objectives: To evaluate the use of local smoking cessation clinics and their effects in terms of smoking cessation (primary prevention) To evaluate the outcomes of the program in terms of number of patients with early (presymptomatic) lung cancer treated with minimally invasive surgery (secondary prevention) To evaluate the number of false positives and their diagnostic work-up (PET-CT, CT-guided biopsy, bronchoscopy) Primary endpoint: - Percentage of enrolled subjects to whom the program was offered within 60 days from the date of enrolment and percentage of those who stop smoking for at least 12 months Secondary endpoints: To describe the organizational model, human resources employed, difficulties encountered and elements that have favoured its realization To measure the variation in smoking habits in enrolled smokers To describe the effect of annual LDCT on lung cancer diagnosis rates, considering size, shape, histology and site To measure the consequent demand for further diagnostic investigations and treatment To measure the number of false positives Subjects at high risk of lung cancer screened by the medical team of the AOUPR or by GPs to join the prevention program. Inclusion criteria Age between 50 and 75 years Equivalent tobacco intoxication of ? 15 cigarettes per day for ?25 years or ? 10 cigarettes per day for ?30 years Status of current smoker or ex-smoker for <10 years. Exclusion criteria • Personal history of cancer within the prior 5 years We expect to recruit around 500 people in 1 year. This sample size is considered adequate based on the available resources, both human and economic. After closing and adjusting the database and before data analysis, a document called Statistical Analysis Plan (SAP) will be drawn up. It will consist of the following paragraphs: Statistical methods planned in the study protocol; Size of the sample; Management of missing data; Evaluation of the endpoints; Statistical models that will be applied in the analysis. The socio-demographic characteristics of the enrolled subjects, the adopted organizational methods and the effects of the prevention program (endpoints) will be analyzed and described using tables and figures. The project "PRogetto Salute Parma: Primary and secondary prevention of smoking-related lung cancer" will be started once approved by the institutional Ethics Committee and authorized by the General Manager. The study is expected to be carried out over 2 years (from the inclusion of the first subject), with an expected period of 1 year for the enrolment and 1 further year for follow-up.

Start: February 2020

Version 2 of the Smoking Cessation Smartphone App "Smiling Instead of Smoking" (SiS)

The overall goal of this pilot study is to solicit feedback from nondaily smokers looking for smoking cessation support online (n=90) about Version 2 of a smartphone app investigators designed to support smoking cessation, and to test if within-person theorized mechanisms of change are occurring as participants undergo the app-assisted quit attempt. Data sources will be passively collected smartphone app usage data, surveys and, in a sub-sample (n=20), online video-conference user feedback sessions. Results will be used to guide the design of Version 3.0 of the "Smiling Instead of Smoking" (SiS) smartphone app. Specifically, the aims of this study are to: Assess ease-of-use and helpfulness of the app, as rated by app users 6 weeks after their chosen smoking cessation date Test if within-person changes occur in theorized mechanisms of behavior change as nondaily smokers undergo a SiS app assisted quit attempt Identify app features in need of improvement, as identified by passively recorded app usage patterns, REDCap open-ended survey items, and, in a sub-sample, user feedback sessions (n=20)

Start: June 2019

Building Capacity and Promoting Smoking Cessation in the Community Via "Quit to Win" Contest 2018

The present study will examine (1) the effectiveness of a combined intervention of face-to-face brief cessation advice (AWARD), active referral of SC service plus financial incentive on encouraging SC services use and (2) explore the use of CBPR model to build capacity and to engage community partners in taking on this important public health issue for sustainability in the community. In addition, a process evaluation will be conducted to assess the effectiveness of the recruitment activity and how it is linked with the overall program outcomes.

Start: June 2018

Gut Hormones in Obesity, Nicotine and Alcohol Dependence

The "Gut Hormones in Addiction" study is a proof-of-concept experimental medicine human study to answer the following questions: Does the administration of the hormone desacyl ghrelin reduce core behavioural components of addiction in dependent individuals who have recently stopped smoking tobacco or drinking alcohol, or overweight/obese subjects? Does the administration of the drug Exenatide reduce core behavioural components of addiction in dependent individuals who have recently stopped smoking tobacco or drinking alcohol, or overweight/obese subjects? Does the administration of desacyl ghrelin or Exenatide reduce reward responses to high-calorie foods and appetite in dependent individuals who have recently stopped smoking tobacco or drinking alcohol, or overweight/obese subjects?

Start: August 2015

Combining Varenicline and Bupropion for Smoking Cessation

The goal of this clinical research study is learn if the combination of Chantix (varenicline) and Zyban (bupropion) is more effective at helping people to quit smoking than varenicline when given alone. Researchers also want to learn if this drug combination can reduce cravings and other negative symptoms of nicotine withdrawal better than varenicline does alone. The safety of this drug combination will also be tested.

Start: May 2010

Helping Moms Who Smoke

The purpose of this study is to learn how women's smoking changes during their pregnancy and as a new mom, and to assess the help they receive from their health care providers.

Start: March 2019

Randomized Trial of Electronic Cigarettes With or Without Nicotine in Smoking Cessation.

Background: Electronic cigarettes (EC) mainly containing nicotine (88-95 % of users) are widely and growingly used worldwide. It is estimated that there were 1.7 million daily users in France in 2016. Although the number of publications about its use is increasing exponentially, there are no evidence based, unbiased, head-to-head comparison data about its efficacy as an aid to smoking cessation. As of today, only two head-to-head randomized studies have been published, both reported negative results at the main endpoint but they used first and second generation EC delivering nicotine with low or unknown bioavailability. Recent EC deliver nicotine with largely improved bioavailability. One of the randomized studies compared EC with and without nicotine to nicotine patch and reported similar smoking cessation rate at main outcome. However, there is no published, double blind study comparing EC use with a well-studied, licensed smoking cessation medication. Superiority of EC with nicotine compared to EC without nicotine and to a reference smoking cessation medication while collecting also straightforward information about safety, would allow proposing EC with nicotine to the large population of smokers who intend to quit and situate it among the approved smoking cessation treatments. The clinical study's hypothesis: EC containing nicotine can be considered as a nicotine replacement therapy having, probably, a better bioavailability of nicotine than the marketed pharmaceutical NRTs, first line medications of smoking cessation. It is therefore of interest to compare EC containing nicotine to EC without nicotine but also to a reference medication with demonstrated efficacy in smoking cessation. We hypothesize that EC with nicotine provides a higher smoking abstinence rate than EC without nicotine and may be as good as varenicline, our reference medication.

Start: October 2018