Treatment Trials

90 Clinical Trials for Various Conditions

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COMPLETED
Impact of Nicotine Messaging on Nicotine Beliefs and Tobacco Use Behavior
Description

This is a 2-arm, randomized controlled, population based trial to test the impact of multiple exposures to brief nicotine corrective messages among adult tobacco cigarette smokers and non-smokers followed in waves over 12 weeks. The primary outcome, assessed at wave 1 (baseline), wave 2 (weeks 5-6), and wave 4 (weeks 11-13) is nicotine beliefs. Secondary outcomes assessed at the same time points include intention to use nicotine/tobacco products and nicotine/tobacco use.

COMPLETED
Smoking Prevention Through Social Connections Among Adolescents - ASPIRE
Description

The central hypothesis of this study is that the addition of social influence strategies to a web-based program called ASPIRE will boost its success in lowering intention to use tobacco among adolescents and experiencing stronger positive social influence. The study will involve a nested group randomized controlled trial with adolescents from after-school programs and schools (e.g., the PK Yonge school) in Florida.

RECRUITING
Impact of Semaglutide on Tobacco Use and Related Health Behaviors
Description

This pilot randomized trial will assess the impact of 12 weeks of semaglutide administration (vs placebo) on changes in: (i) tobacco use and related factors (nicotine craving, withdrawal, motivation to quit, etc.) and (ii) biological biomarkers of health (e.g., epigenetics, glucose variability via continuous glucose monitoring \[CGM\], etc.) in adult smokers with obesity (n = 40). We will integrate molecular biology procedures (e.g., epigenetics) to maximize internal validity with real-world smartphone-based ecological momentary assessment (EMA) surveys to maximize external validity

Conditions
RECRUITING
Effect of Cannabis on E-Cigarette Use Behavior
Description

The purpose of this study is to determine the impact of tetrahydrocannabinol (THC) administration on motivational, subjective, and physiological effects of electronic cigarettes. The study's goals are to test demand for e-cigarettes, tobacco craving, affect, heart rate, blood pressure, expired breath carbon monoxide, and cognitive performance. Researchers will compare multiple doses of THC and a placebo in participants who smoke e-cigarettes and either smoke or vape THC in the laboratory.

RECRUITING
Effect of Cannabis on Cigarette Use Behavior
Description

The purpose of this study is to determine the impact of tetrahydrocannabinol (THC) administration on motivational, subjective, and physiological effects of cigarettes. The study's goals are to test demand for cigarettes, tobacco craving, affect, heart rate, blood pressure, expired breath carbon monoxide, and cognitive performance. Researchers will compare multiple doses of THC and a placebo in participants who smoke cigarettes and either smoke or vape THC in the laboratory.

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.

RECRUITING
Linking Brain Network Dynamics to Imminent Smoking Lapse Risk and Behavior
Description

Most attempts to quit smoking end in relapse, or a return to regular smoking. One of the biggest threats to cessation is a lapse (i.e., any cigarette use during a quit attempt). Thus, characterizing why lapses occur is essential to understanding and preventing smoking relapse. Functional magnetic resonance imaging (fMRI) is a promising method for characterizing the psychological processes that lead to smoking lapses because it provides a way to measures patterns of brain activity thought to reflect relevant mental processes as they change over time. However, methodological issues have hindered the ability to capitalize on this potential and prevented an understanding of how brain activity and corresponding psychological processes unfold in the critical moments that immediately precede a smoking lapse. The proposed project will address this knowledge gap using a novel fMRI paradigm adapted from a well-validated behavioral lapse task. The goals of the project are to characterize changes in brain activity that lead up to a lapse and to investigate how these changes are related to concurrent affect and subsequent cigarette use.

COMPLETED
Use Behavior, Nicotine Uptake, and Subjective Effects Comparison of Tobacco and Menthol e-Liquids by ENDS Consumers
Description

This study is being conducted to evaluate the impact of within-flavor category (tobacco and menthol) differences in e-liquid flavors on product use behaviors, nicotine uptake, and subjective effects by current ENDS consumers when used in a closed-system electronic nicotine delivery system (ENDS).

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
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
COMPLETED
CSD1805: Study to Assess Nicotine Uptake and Product Use Behavior in Moist Snuff Consumers Using Two Moist Snuff Products
Description

The purpose of this study is to compare nicotine uptake and product use behavior during and following use of two moist snuff products in generally healthy, adult moist snuff users.

Conditions
COMPLETED
Effect of a Non-Invasive Brain Stimulation Technique on Smoking Cessation Behaviors
Description

In this pilot study, the feasibility of using tDCS (a non-invasive brain stimulation technique) while performing a task requiring cognitive flexibility will be examined in smokers and initial data will be collected regarding the effect of tDCS on smoking cessation behaviors. Smokers will be randomized to receive either active or sham tDCS daily for 5 days after which they will attempt to quit smoking. Smoking behavior after the attempted quit date will be assessed at four weekly visits.

COMPLETED
Teens Against Tobacco Use: A Tobacco Prevention Curriculum and Advocacy Initiative
Description

This study evaluates the efficacy of Teens Against Tobacco Use anti-tobacco presentations on tobacco use susceptibility in 6th through 8th grade. Students will be randomly assigned to either receive 3 anti-tobacco presentations or 3 presentations on a different topic, unrelated to tobacco.

COMPLETED
Longitudinal Evaluation of Teens Against Tobacco Use
Description

This study evaluates the efficacy of Teens Against Tobacco Use anti-tobacco presentations on tobacco use susceptibility in 4th-8th grade. Classrooms are randomly assigned to either receive a series of two presentations or wait listed to receive them later in the school year.

COMPLETED
Teens Against Tobacco Use: A Model for Universal Tobacco Prevention and Youth Advocacy
Description

This study evaluates the efficacy of Teens Against Tobacco Use anti-tobacco presentations on tobacco use susceptibility in 4th-8th grade. Classrooms are randomly assigned to either receive a series of two presentations or wait listed to receive them later in the school year.

COMPLETED
Reduced Nicotine Content Cigarettes and Tobacco Switching Behaviors
Description

The main focus of this study is to determine the use of nicotine-containing products across the three experimental conditions. Subjects will be monitored to determine their continued use of assigned cigarettes, switching to other combusted and/or non-combusted tobacco, or cessation of all tobacco containing products.

COMPLETED
A Study to Examine Health Behavior Change Strategies for Primary Care
Description

Prescription for Health is a national program of The Robert Wood Johnson Foundation (RWJF) in collaboration with the Agency for Healthcare Research and Quality (AHRQ). A major goal of Prescription for Health is to measure the extent to which comprehensive strategies are effective in changing patient behavior and quality of life relative to four target health risk behaviors: diet, smoking, alcohol use, and physical activity. The funded projects will use a common set of survey instruments to help measure outcomes and draw overarching conclusions across projects. This study will only be analyzing aggregated data and does not have responsibility for recruitment of patients, randomization (if applicable), or interventions. Individual project designs may differ.

COMPLETED
Reducing Health Risk Behavior and Improving Health in Adolescents With Depression
Description

This study will determine the effectiveness of a health education intervention in reducing health risk behavior and improving health in adolescents with depression.

COMPLETED
Effect of Progesterone on Smoking Behavior in Male and Female Smokers
Description

Past research on nicotine addiction has shown that changes in estradiol and progesterone hormone levels during menstruation may cause women to respond differently than men to nicotine. The purpose of this study is to examine the effects of progesterone on smoking behavior, nicotine withdrawal symptoms, and the reinforcing effects of smoking in men and women addicted to nicotine.

UNKNOWN
CHERL, Connecting Primary Care Patients With Community Resources to Facilitate Behavior Change
Description

The investigators want to find out if providing a Community Health Educator Referral Liaison (CHERL) helps practices help their patients change risky behaviors (tobacco use, physical inactivity, unhealthy diet, and risky drinking) by connecting patients to available services in the community or directly providing behavior change support.

COMPLETED
Effect of Bupropion on Smoking Behavior in Smokers With Schizophrenia
Description

Many individuals with schizophrenia smoke cigarettes but little is known about the factors that control smoking in people with schizophrenia. The purpose of this trial is to evaluate how bupropion, an antidepressant medication, affects smoking behaviors in individuals with schizophrenia who smoke.

ACTIVE_NOT_RECRUITING
A Behavioral Activation Prenatal and Postpartum Intervention for Depressed Pregnant Smokers
Description

This study evaluates a mood management and health and wellness smoking cessation intervention for depressed pregnant smokers during and after birth. This study may help pregnant smokers who are experiencing depression quit smoking and stay smoke-free after their babies are born.

RECRUITING
Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings
Description

The study team will conduct a Multisite Randomized Controlled Trial to evaluate the advantages and disadvantages of two approaches for quitting smoking among people with serious mental illness (SMI). The study will compare a novel app tailored to people with SMI, Quit on the Go, to a standard of care smoking cessation intervention. We will test the effectiveness of the Quit on the Go app, an intervention that has demonstrated feasibility and acceptability in the target population, as a tool for smoking cessation in people with SMI. Participants with SMI will be recruited across 3 sites (Duke University, Univ. at Buffalo, and Wake Forest University).

UNKNOWN
Comparative Tobacco Interventions for Individuals With Severe and Persisting Behavioral Health Disorders
Description

The aim of this pilot intervention is to examine the acceptability of a harm reduction intervention approach to tobacco use for individuals with serious behavioral health disorders and its association with a decrease in smoking. The intervention uses a "dynamic" approach to patient choice, allowing participants the option to explore different strategies for harm reduction, while providing support from counselors in the process. Therefore, the investigators have chosen an observational study design in order to document and explore the acceptability and outcomes of the intervention.

Conditions
RECRUITING
Smoking Cessation Behavioral Treatment Study
Description

The purpose of this study is to evaluate the effectiveness of two behavioral interventions on smoking behavior - Mindfulness-Oriented Recovery Enhancement (MORE) and Cognitive Behavioral Therapy (CBT). MORE is a behavioral therapy that integrates mindfulness training to modify reward processes. CBT is a therapy designed to help individuals understand how their thoughts and feelings influence their behaviors.

COMPLETED
Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC): Reducing Tobacco Use Among Opioid Addicted Women
Description

This study tests an intervention for tobacco cessation (named B-EPIC) in an established community medication assisted treatment (MAT) clinic for pregnant and postpartum women with opioid dependence. Half of the participants will receive the intervention for tobacco cessation, which is standard cessation counseling from the provider plus additional cessation support from a Certified Tobacco Treatment Specialist (CTTS). The other half of participants will receive standard tobacco cessation from their provider. The project will also determine the economic impact of the B-EPIC intervention on healthcare expenditures.

COMPLETED
Behavioral Economic Purchasing Decisions for Cigarettes of Varied Compositions
Description

The purpose of this study is to determine whether the abuse liability of cigarettes with altered composition (cigarettes differing in composition; e.g., tar levels, amount of sugar, casings) is reduced relative to standard composition cigarettes.

ACTIVE_NOT_RECRUITING
Behavioral Activation Therapy and Nicotine Replacement Therapy in Increasing Smoking Cessation
Description

This randomized clinical trial studies how well behavioral activation therapy and nicotine replacement therapy work in increasing smoking cessation. Behavioral interventions use techniques to help patients change the way they react to environmental triggers that may cause a negative reaction. Giving behavioral activation therapy and nicotine replacement therapy may help patients quit smoking or change their smoking behavior.

COMPLETED
N-Acetyl Cysteine Plus Behavioral Therapy for Nicotine Dependent Pathological Gamblers
Description

The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and pathological gamblers (PG) symptoms in nicotine dependent pathological gamblers.