Treatment Trials

276 Clinical Trials for Various Conditions

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RECRUITING
Nicotine and Tobacco Message Framing to Change Smoking Behavior in Diverse Groups of Young Adult Smokers
Description

This clinical trial evaluates the effect of message framing on smoking behaviors among lesbian, gay, bisexual, transgender, queer (LGBTQ+) young adults who use nicotine and/or tobacco. Tobacco regulation has contributed to a steady decline in tobacco products designed to be smoked (combustible), but there has been an increase in the use of new tobacco products, such as electronic nicotine delivery systems (ENDS). The use of more than one tobacco product (polytobacco) is high in LGBTQ+ populations. Both LGBTQ+ people and people who engage in polytobacco use are less likely to view tobacco as harmful, which may reinforce tobacco use. Message framing includes culturally targeted messages to communicate the absolute risks (AR) and relative risks (RR) of polytobacco use. Using message framing may increase quit rates or change smoking behaviors in LGBTQ+ young adults who use nicotine and/or tobacco products.

RECRUITING
Feasibility of Conducting a Pilot Telehealth Study Assessing the Removal of Filter Ventilation on Smoking Behavior and Biomarkers in Menthol Smokers Switched to Non-menthol Cigarettes
Description

This decentralized clinical trial assesses the feasibility of conducting a tobacco product evaluation study remotely via telehealth visits and mailed samples. This is an open label, between-subject, randomized pilot study to assess the effect of minimal filter ventilation vs. moderate filter ventilation on smoking behavior and biomarkers of exposure (e.g., nicotine, carbon monoxide) in menthol smokers switched to non-menthol cigarettes. Subjective measures, alveolar carbon monoxide, blood pressure and cigarettes smoked per day will be collected remotely. Biological samples will be collected at home and mailed into the clinic.

Conditions
RECRUITING
A Comprehensive Evaluation of Tobacco-Flavored vs. Non-Tobacco Flavored E-cigarettes on Smoking Behavior
Description

This clinical trial compares the use of tobacco flavored electronic cigarettes (ECs) vs. non-tobacco flavored ECs vs. nicotine replacement therapy (patches and lozenges) on smoking behavior in current cigarette smokers. ECs may reduce cigarette craving and withdrawal symptoms, increase motivation and confidence to stop cigarette smoking, and decrease cigarette smoking and dependence. By comparing participants' preferred flavor ECs (PEC) to tobacco flavor ECs (TEC) to NRT, researchers hope to determine the effect of EC flavors on appeal and use and learn how ECs affect smoking behaviors and health.

RECRUITING
Effect of Flavored on!® Nicotine Pouch Products on Smoking Behaviors: a SMART Study
Description

The goal of this clinical trial is to learn about the role of flavored on!® nicotine pouch products (the research products), an oral tobacco-leaf-free product, in the replacement of cigarettes with the use of the research products among adults who smoke cigarettes. The main question it aims to answer is whether flavored (vs. non-flavored) research products generate greater reduction of cigarette smoking among adults who smoke cigarettes. Participants will be provided with research products to use for 6 weeks. Researchers will compare the reduction in cigarette smoking between participants with access to a complete flavor profile of research products and participants with access to only the Original (non-flavored) variety of research product to see if reduction in cigarette smoking is greater among those with access to flavored research products.

RECRUITING
Deep rTMS Modulating Insula Synaptic Density and Smoking Behavior in Schizophrenia
Description

Purpose of the study: Evaluate the effect of deep repetitive transcranial magnetic stimulation (deep rTMS; hereafter abbreviated as "dTMS") on synaptic density measured with positron emission tomography (PET) and the radiotracer \[11C\]UCB-J. The investigators also seek to link plasticity changes in the regions targeted by the electric field (especially, the insula) to changes in the functioning of insula circuits and behavioral cigarette usage in patients with schizophrenia (SCZ). Importance of the study: This is the first study designed to directly evaluate the mechanism of action (MOA) of dTMS for smoking disruption in patients with SCZ. Patients with SCZ are a vulnerable population in high, immediate need of new smoking therapeutics for reducing premature morbidity and mortality.

COMPLETED
Effect of Waterpipe Size on Smoking Behavior and Exposures
Description

This project will generate novel evidence regarding the effect of waterpipe size on smoking behavior, toxicant exposures and subjective experiences among waterpipe smokers. Findings from this project will help the FDA in developing waterpipe size-specific regulations to curb waterpipe smoking in the US and protect public health.

Conditions
RECRUITING
Ethnic Microaggressions and Smoking Behaviors Among Latinx Adults
Description

The purpose of this study is to examine whether microaggressions relate to multimodal facets of smoking behavior, subjective withdrawal, and urge/craving. Additionally, the second aim is to examine whether smoking deprivation moderates the relation between microaggressions and multiple facets of smoking behavior, subjective withdrawal, and urge/craving.

COMPLETED
AAT + tDCS to Reduce Cue-induced Craving and Smoking Behavior
Description

Smokers are highly reactive to smoking-related stimuli and report that this cue reactivity (CR) is a major obstacle to quitting. To date, no pharmacologic methods attenuate CR, and attempts to diminish it with traditional cue exposure treatment (CET) have not proven effective. The proposed study will test a highly novel cue-based smoking treatment adjunct combining an Approach/Avoidance Task (AAT) with brain stimulation via tDCS applied to the dorsolateral prefrontal cortex (dlPFC) during personalized multi-cue exposure; the goal of which is to discover an effective means of reducing cue reactivity and daily smoking, and increasing intent and confidence to quit, among high treatment-interest smokers.

COMPLETED
The Effects of IQOS Use on Cigarette Smoking Behaviors
Description

This within-subjects study aims to evaluate the effects of IQOS use on combustible cigarette smoking behaviors among 100 cigarette smokers who completed the study. After measuring baseline cigarette smoking rate, participants will receive an IQOS device and be instructed to use it (versus cigarettes) over a 14-day period. The investigators will also examine which objective and subjective effects of IQOS use predict a complete and incomplete switch from cigarettes to IQOS.

COMPLETED
Digital Media for Cancer Control (to Prevent Vaping and Smoking Behavior)
Description

There is little published data on exposure to and evaluations of large-scale, online tobacco control campaigns. This project addresses the gap. Under 2 specific aims, the investigators will identify the independent effects of varying levels of digital message exposure to promote anti-tobacco attitudes, beliefs, or behaviors among youth and young adults, first through a randomized experiment online, and second through a field-based evaluation. These studies will advance the science of digital health and have wide application to future campaigns.

Conditions
ACTIVE_NOT_RECRUITING
Evaluation of an "Opt-Out" Inpatient Smoking Cessation Service on Smoking Behavior Study #1
Description

The modest goal of this study is to replicate the behavioral outcomes of the opt out MUSC-Tobacco Treatment Program in the following three patient groups: 1) psychiatric inpatients housed in the Institute of Psychiatry (IOP) in Charleston; 2) non-IOP patients seen in Charleston; and 3) patients seen in the other four MUSC affiliated hospitals combined (i.e., Chester, Florence, Lancaster, and Marion). The aims and the design/methods utilized for evaluation will be the same for each of the three patient groups.

COMPLETED
Effects of Menthol in E-cigarettes on Smoking Behaviors
Description

The overall goal of this proposal is to understand the relationship between nicotine metabolism and menthol flavor in e-cigarettes on smoking behavior in smokers.

RECRUITING
The Effect of Electronic Cigarette Use on Smoking Behaviors Among Smokers Receiving Outpatient Psychiatric Treatment
Description

This study aims to establish the feasibility and acceptability of a project designed to investigate the impact of electronic cigarette use on combustible cigarette smoking and smoking-related factors among smokers with psychiatric disorders, a high-risk population, who are not yet ready to quit smoking. All participants will be instructed to switch completely from combustible cigarettes to e-cigarettes for the next 8 weeks. They will be assessed at baseline, 2 weeks, 4 weeks, 8 weeks and 12 weeks.

TERMINATED
Impact of Cigarette and E-cigarette Flavors on Adult Smoking Behavior
Description

This study will investigate within-person changes in smoking behavior when current menthol smokers are switched to non-menthol cigarettes and either tobacco or menthol flavored e-cigarettes.

Conditions
TERMINATED
Mindfulness Training Plus Oxytocin Effects on Smoking Behavior
Description

The purpose of this study is to examine the effects of mindfulness training and a drug called oxytocin on smoking.

TERMINATED
Neuro Biomarkers of Smoking Behavior
Description

The purpose of this study is to evaluate cognition in smokers and nonsmokers. It involves administration of intranasal insulin (Novolin R), an investigational medication followed by a brief non-invasive cognitive test. All participants will receive both Novolin R and placebo in two separate testing sessions.

COMPLETED
Effects of Nature Exposure on Smoking Behavior
Description

Smoking continues to be the leading cause of preventable death and disease in the U.S. While smoking is a significant threat to public health in the US in general, the negative effects of smoking disproportionately affect Americans with 12 or fewer years of education and those living below the poverty line. Given these health disparities, it is vital to have widely-available treatments that can be applied in multiple contexts in a cost-efficient way. While numerous methodologies and intervention programs exist, there is a need for improved cessation programs targeted to smokers with low levels of education attainment and income, as these smokers tend to be less likely to receive cessation assistance from a health care provider or have sufficient resources to access treatments. Therefore, the present proposal aims to assess the feasibility of a tool that will improve smoking cessation programs in a short and cost-effective manner: a brief exposure to nature. The health and wellbeing benefits of nature exposure have been well researched and are widely recognized, and research on the underlying mechanism for nature's positive impact on health has identified a reduction in impulsivity as a mediator of this effect. However, this work has never been directly translated to smoking outcomes, and thus the translational purpose of the present project is to assess the feasibility of a brief and cost-effective nature exposure intervention on smoking cessation outcomes. Prior work demonstrates the validity of the causal links in the nature -\> impulsivity -\> smoking cessation model. Research has shown that nature exposure reduces impulsivity for health-related outcomes, and found that increased impulsivity is linked to all stages of smoking. A necessary step in developing a practical application for this research is the aim of the present project. Smokers will be recruited online and randomly assigned to either the Nature or Control condition. Participants in the Nature condition will be given a nature-based intervention, while participants in the Control condition will be given a non-nature-based intervention. Participants will be contacted via text message throughout the following 24 hours and asked to report their degree of urgency to smoke and number of cigarettes smoked. Participants will complete measurements of impulsivity, income, socio-economic status, and education, and additional smoking-related constructs.

Conditions
COMPLETED
AXS-05 Phase II Trial on Smoking Behavior
Description

This research study is designed with the purpose of evaluating a new drug, combination Dextromethorphan-Bupropion (AXS-05), for its effects on smoking behavior.

RECRUITING
Understanding How Cigarette Direct Mail Marketing Influences Smoking Behaviors Among High and Low Socioeconomic Status Young Adult Smokers
Description

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

COMPLETED
Theta Burst TMS as a Tool to Change Smoking Behavior
Description

The goal of this study is to determine whether transcranial magnetic stimulation (TMS) is an effective treatment in decreasing craving in individuals who habitually smoke cigarettes. The study consists of six total visits to MUSC; one for the consent process, two that will include MRI scans, and five that will include TMS administration. Compensation will be provided for each visit.

COMPLETED
A Study in a Human Laboratory Model of Smoking Behavior
Description

A Randomized, Double-Blind, Placebo-Controlled, Crossover Design Study of CERC-501 in a Human Laboratory Model of Smoking Behavior.

Conditions
TERMINATED
Effects of Nicotine Reduction on Smoking Behavior in ADHD Smokers
Description

The purpose of this study is to investigate the impact of different nicotine levels in cigarettes with individuals who have ADHD.

COMPLETED
Effects of Implicit Messaging by Cigarette Pack Color on Smoking Behaviors
Description

The purpose of this study is to examine the effect of changes in cigarette package color and warning label features on smoking behaviors and beliefs about cigarette risks.

COMPLETED
Mobile Sensing of Smoking Behavior
Description

Smokers will use a smartphone app on a smartphone provided for the study that will passively sense and record information about their activities. Information collected from the smartphone app will be used to develop future smartphone apps that will predict when an individual is at risk of smoking.

Conditions
WITHDRAWN
Cotinine Feedback as an Intervention to Change Parental/Caregiver Smoking Behavior Around Children With Cancer
Description

RATIONALE: Providing parent/caregivers of children with cancer with education and evidence of secondhand smoke exposure can protect the child from future exposure to tobacco smoke. PURPOSE: This randomized study will compare education only to education plus cotinine feedback in decreasing secondhand smoke exposure in pediatric patients with cancer that reside with a household smoker.

WITHDRAWN
fMRI of Stress in Smoking Behavior
Description

To examine the influence of current daily tobacco smoking on brain activation during stress, tobacco cue, and neutral relaxing conditions

Conditions
COMPLETED
Measuring Smoking Behaviors While Using Varenicline
Description

This study will demonstrate the behavioral responses to varenicline, helping to better understand its mechanisms. Hypotheses for the study are to observe decreases in smoking topography and nicotine cigarette choice on varenicline, relative to placebo; and decreases on day 21 relative to day 7 during varenicline treatment. We also propose to examine if extended duration of treatment has clinical significance in decreasing smoking behaviors, thus increasing the efficacy of varenicline.

COMPLETED
Modeling Stress-precipitated Smoking Behavior for Medication Development
Description

The purpose of this study is to examine whether guanfacine will attenuate the ability of stress to precipitate smoking lapse behavior in treatment seeking and non-treatment seeking daily smokers.

Conditions
COMPLETED
The Effect of Cycloserine on Smoking Behavior in Nicotine Dependent Smokers
Description

A total of 20 subjects will participate in this four week, between groups, double-blind, placebo controlled study. Subjects will participate in two experimental sessions separated by approximately one week. Subjects will be randomized to receive either 50 mg cycloserine or placebo combined with cue exposure. Several physiological and subjective outcome measures (e.g., heart rate, blood pressure, galvanic skin response) will be obtained during the sessions. Experimental sessions will last approximately 4.5 hours with follow-up sessions lasting approximately thirty minutes. Our aims are: 1. To examine the effect of cycloserine vs. placebo on extinction of smoking cue reactivity in overnight abstinent smokers. Reactivity to smoking cues will be captured with self-report smoking urges and physiological measures (heart rate, blood pressure, and skin conductance). We hypothesize that cycloserine, relative to placebo, will facilitate extinction of smoking cue reactivity. 2. To examine the effect of cycloserine vs. placebo when combined with two 4.5 hour laboratory cue exposure training sessions, on smoking behavior in smokers. Smoking behavior will be measured with self-report smoking and saliva cotinine levels. 3. To examine the effect of cycloserine vs. placebo on memory performance in nicotine dependent smokers. Memory performance will be measured with verbal learning, recognition and recall tasks. 4) To examine the safety and tolerability of cycloserine treatment in smokers. We hypothesize that cycloserine will be well tolerated by smokers.

Conditions
UNKNOWN
Pilot Study of the Feasibility of Palm Pilots in Monitoring Smoking Behavior in Individuals With Chronic Mental Illness
Description

The goal of this open trial is to pilot the use of palm pilots as a tool for monitoring smoking behavior in individuals with serious mental illness. That is, the investigators aim to assess the usefulness and feasibility of using Palm Pilots as a tool for monitoring smoking behavior and for coaching participants to use a strategy for delaying and reducing cigarette use.

Conditions