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16 active trials for Smoking Behaviors

Interventions to Help More Low-income Smokers Quit

In a Hybrid Type 2 randomized trial, 1,980 low-income smokers from nine states with high smoking prevalence will be recruited from 2-1-1 helplines to receive either current standard practice (Quitline) or expanded services (Quitline + Smoke Free Homes) to increase tobacco cessation.

Start: March 2020

C-FLASH (Cigarillo Flavor and Abuse Liability, Attention, and Substitution in youtH)

The purpose of this research is to understand how flavor affects young adult's perceptions of little cigar or cigarillo use.

Start: May 2020

Development and Assessment of a Teacher-led Intervention in Preventing Tobacco Use Among the Youth in Ghana

The main purpose of this experimental study is to compare the existing health education program for School Health and Education Program (SHEP) in the Junior High Schools with a new health education model (Smart-Kids') for the prevention of smoking initiation and to improve the quit rate among students in Upper East Region of Ghana. The intervention will be based on the Theory of Triadic Influences (TTI) which involves the cultural environment in which adolescents mature, their immediate social situation, and intrapersonal differences. These three factors impact through different mediating variables, such as attitudes, normative beliefs, and self-efficacy, which eventually affect smoking intentions and smoking behavior as the outcome measures. The study design is a cluster randomized control trial. After baseline assessment, the investigators will randomize schools to receive the new health education for three months whiles the comparator (control group) will continue with the usual health education. The investigators will conduct a post-intervention assessment using the same questionnaire with unique identity codes linking each participant to their baseline assessments immediately at the end of the intervention. Final assessment will be done approximately three months after the intervention. The investigators will assess and compare the effectiveness of the new health model to the normal health promotion programs (SHEP). The investigators hypothesized that there will be no significant differences observed between the new teacher-led health education program (the Smart-Kids Program) and the existing SHEP coordinator-led in preventing smoking uptake among the youth. Alternatively, the new teacher-led health education program would facilitate the effects of the program on outcomes. on four key primary endpoints as follows: H1: The intervention study will result in a 30% reduction in smoking uptake H2: The intervention study will result in a 10% reduction in smokers H3. The intervention will increase knowledge of the harmful effects of tobacco use by 50% H4. The intervention will increase the willingness to quit smoking by 10% among smokers

Start: June 2021

Isradipine Enhancement of Virtual Reality Cue Exposure for Smoking Cessation

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.

Start: January 2020

Heat-not-burn Tobacco Product to Aid in Switching From Combustible to Noncombustible Nicotine (IQOS)

A novel heat-not-burn tobacco product (IQOS) will be provided to smokers screened for lung cancer risk, compared against a (cigarette) smoking as usual period in counter-balanced order in a cross-over design. This study will examine the short-term effects of IQOS, switching from combustible to noncombustible nicotine and withdrawal-related symptoms over a two week-long "practice" period, relative to smoking as usual.

Start: May 2021

Clinical Learning Study for a Mobile Smoking Cessation Program

The purpose of this study are to obtain learnings regarding the Digital Therapeutic (DTx) experience of Clickotine, including acceptability and preference of the overall program and specific DTx components, as well as to obtain learnings related to adult participants' use of the DTx for smoking cessation.

Start: March 2021

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

Switching to Potential Reduced Exposure Products in Adult Smokers

This study aims to assess the feasibility, acceptability, and the potential harm reduction of switching to potentially lower risk, oral nicotine pouches in adult smokers. Part One of this study aims to assess the interest of current smokers in switching to an e-cigarette device (i.e. JUUL) compared to alternative non-combustible tobacco products (i.e. smokeless tobacco/snus) and/or medicinal nicotine via survey. Part Two will consist of a pilot study of 30 non-treatment seeking adult smokers to investigate within-person changes in smoking behavior as a result of switching to different concentrations of oral nicotine pouch products (i.e. ZYN, 3mg and 6mg nicotine concentration). Additionally, by measuring bio-markers of tobacco exposure from baseline, this will allow the study to assess the potential for harm reduction in switching from cigarettes to oral nicotine pouches.

Start: May 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

Cigarette Smoking Among Young Adults

This study will examine perceptions and smoking behavior of menthol and non-menthol very low nicotine cigarettes in young adult smokers. The aims are to examine perceptions and smoking behavior in the laboratory and in the natural environment.

Start: April 2021

Smoking Cessation Pilot for People Living With HIV (PLWH)

The overall goal of this pilot study is to evaluate the feasibility of the Lumme smartphone app for smoking cessation in people living with HIV (PLWH) and evaluate its effect on smoking cessation. Mobile health (mHealth) technology can be used for achieving health equity in vulnerable groups because it is a widely available and relatively inexpensive tool for health behavior change and can be adapted to meet the needs of its end-users. Therefore, a mHealth intervention such as the Lumme App proposed through this study is timely, relevant, scalable and likely to improve health outcomes in PLWH who smoke.

Start: March 2020

CSD210202: A Study to Assess Nicotine Uptake From Electronic Nicotine Delivery Systems

This is an open-label, randomized, 5-way crossover study designed to evaluate plasma nicotine pharmacokinetic (PK) parameters following an ad libitum use of Electronic Nicotine Delivery System (ENDS) investigational products (IPs) in a confinement setting by generally healthy combustible cigarette (CC) smokers.

Start: February 2021

Digitally Enhanced Smoking Cessation for High Risk Smokers

This is a research study, is testing a program to improve lung health through smoking cessation and providing education around lung screening. In this research study involves Studying the Enhanced Smoking Cessation Approaches to Promote Empowerment (ESCAPE) program compared to usual care. The ESCAPE program was developed help women with HIV quit smoking. Women in the ESCAPE program quit smoking and stayed quit for longer (up to 3 months). For this study, investigators have added a lung screening to the ESCAPE program and want to test if this will improve lung health through increasing quit rates and lung screening. .

Start: May 2021

CSD190601: A Study to Determine Subject Puffing Patterns of Electronic Nicotine Delivery Systems in an Ambulatory Setting

This study will be a single-center, controlled, open-label, parallel two-study-group investigation to evaluate the puffing patterns of healthy adult consumers of tobacco products switching from a usual brand (UB) Electronic Nicotine Delivery Systems (ENDS) product to one of two different ENDS, Product A with 1.5% nicotine, and Product B with 3.0% nicotine, over a three-week ambulatory period. This study will be conducted in support of a Premarket Tobacco Product Application (PMTA) ENDS submission to the US Food and Drug Administration (FDA) Center for Tobacco Products (CTP).

Start: May 2020

Impact of Smoking and Nicotine on the Risk of Being Infected With COVID-19

Several studies have shown that smokers have a higher risk of developing a severe form of COVID-19 once a person has been infected. This is explained by the damage caused by smoking at the bronchopulmonary level and an overexpression of some coronavirus receptors at the pulmonary level when exposed to tobacco. In contrast, recent data indicate that smokers are proportionally less infected with the COVID-19 virus since all available cohort data from around the world show a very low rate of smokers among COVID-19 infected subjects. The mechanisms at the origin of this protective effect are not known. All of these data lead us to question the real role of nicotine in the protective effect of tobacco observed in the general population against infection by the COVID-19 virus. The objectives are : To show that subjects taking nicotine substitutes as part of a smoking cessation program are less infected with COVID-19 than non-smokers. To show that active smokers are less infected with COVID-19 than non-smokers. To compare the percentage of positive serological tests in subjects taking nicotine substitutes to the percentage of positive serological tests in active smokers.

Start: July 2020

Pivot Breath Sensor Study

Prospective open label, single center study enrolling up to 220 participants to evaluate the effect of the Pivot Breath Sensor on a user's attitudes towards quitting smoking and smoking behavior.

Start: September 2019