89 Clinical Trials for Various Conditions
This early phase I trial studies how well A Smoking Prevention Interactive Experience (ASPIRE) program and mentorship works in preventing smoking in high school students. ASPIRE is an online-based, youth-centered tobacco prevention and cessation program. The goal of this research study is to learn if training eleventh grade high school students to be tobacco-free role models and mentors for ninth grade high school students is possible and will positively influence the younger peers.
The purpose of the current proposal is to investigate the extent to which interventions designed to improve cognitive (working memory) and emotional (distress tolerance) regulatory processes enhance the effectiveness of standard no-smoking informational interventions. Emotional and cognitive dysregulation increases the likelihood of smoking and makes it particularly challenging to benefit from standard interventions. Working memory and associated deficits make it more difficult for individuals to utilize information from interventions, make judicious decisions regarding the cost and benefits of smoking, and to resist targeted advertising. In addition, disruptions in emotion regulatory capacities increase the probability of using cigarettes as a coping mechanism to self-regulate negative affect and stress. Individuals with affective disturbances smoke at higher rates and have more difficulties quitting, and are more likely to smoke as a way to reduce negative affect. The goal of the current project is to generate new insights and new approaches to smoking prevention among low-SES youth by investigating (1) the influence of known SES-related deficits in working memory and affect regulation on proximal measures of smoking risk, and (2) the potential for targeted interventions to reverse these risks. Specifically, the investigators examine the influence of working memory training and distress tolerance (mindfulness) interventions on cognitive/affective targets placing individuals at risk for smoking initiation and maintenance. The specific aims of this study are therefore to investigate: 1. The feasibility and acceptability of school- and community-based brief interventions targeting working memory and distress tolerance in a diverse sample of low SES adolescents. 2. The effects of working memory and distress tolerance interventions, relative to a standard informational intervention alone, on specific cognitive-affective targets-delay discounting and distress tolerance--relevant to cigarette smoking initiation and maintenance. 3. The impact of cognitive /affective target activation on proximal measures of smoking risk/behavior and related health outcomes following intervention.
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.
The Hutchinson Smoking Prevention Project is a 16-year, group-randomized trial to determine the extent to which a school-based (grades 3-10), theory-based, social-influences tobacco use prevention intervention can deter youth tobacco use throughout and beyond high school.
Young adults are particularly vulnerable to psychological distress during the transition from adolescence to adulthood, making them more susceptible to developing persistent substance use. The tobacco industry capitalizes on this vulnerability by using marketing tactics to promote tobacco initiation and facilitate the progression from experimental tobacco use to long-term use. In China, where the average age of starting daily smoking is 21.1 years old, the number of current young adult smokers exceeds 29 million. It is crucial to develop effective communication messages to counter the tobacco industry's marketing strategies and protect the health of young adults in China. This project aims to test the effects of different anti-smoking message themes among Chinese young adults. In this online randomized clinical trial, participants will be randomly assigned to one of five antismoking message conditions. The investigators will compare the effects of these themes with each other and with the control condition.
In a 2x2 design, current menthol smokers (N=240) will complete a baseline period before being assigned to a cigarette (menthol or non-menthol) and e-cigarette condition (menthol or tobacco-flavored e-liquid) and receiving a 7-week supply of cigarettes and e-cigarettes. The study builds upon our well-established methodology for simulating tobacco regulatory policies. To model a ban, smokers will be instructed to only use their assigned products. Primary outcomes include cigarette smoking and e-cigarette use during Week 6. However, because a menthol ban may impact the ability to abstain from smoking, the investigators will incentivize participants to abstain from smoking during Week 7 (continued e-cigarette use allowed) and assess the time to first lapse. Participants will complete daily electronic diaries assessing tobacco product use throughout, which will be corroborated by biomarkers for menthol, nicotine, and smoke. Finally, to maximize the utility of these data for FDA regulation, the investigators will assess whether any demographic or baseline smoking characteristics moderate the observed treatment effects, calibrate the treatment effects to the US adult menthol smoking population, and model the effects of menthol regulation in cigarettes and e-cigarettes on smoking and vaping-attributable deaths and life-years lost.
Transdermal nicotine delivery systems are a cigarette smoking cessation aid designed to deliver nicotine into the systemic circulation via the skin. They have been found to reduce craving, thereby enhancing a patient's success for quitting smoking. However, side effects such as sleep disturbances and skin irritation, as well as incomplete smoking cessation are commonly experienced by users of such systems. Chrono Therapeutics, Inc. has developed an innovative programmable transdermal drug delivery system called the Chrono Quit Smoking Solution (CQSS2) that provides "off" periods (periods in which little to no nicotine is delivered), which is an advantage over existing systems that currently provide continuous delivery. The most important features of the CQSS2 are the periodic automatic dosing, plus the reduced side effects of sleep disturbances and potentially, skin irritation. The period when less nicotine is being delivered through the skin allows the skin an opportunity to "recover", thereby potentially reducing skin irritation. Another major benefit is the automatic dosing, which provides higher drug dosage at specific times of the day, leading to potentially greater success in quitting smoking. In this study, the CQSS2 will be used in conjunction with the Digital Coach application (app). The Digital Coach is a custom mobile app that provides behavioral support for the CQSS2. Together, the CQSS2 and the Digital Coach comprise the CQSS2 System.
The purpose of this study is to design an incentive-based intervention to motivate a tobacco-free lifestyle among high school students and to pilot the intervention in the first academic year in two schools (CT and NY) and examine feasibility and acceptability. Preliminary efficacy of the intervention will be assessed by implementing it in two new schools (CT and NY) in the second academic year and determine an effect size estimate for a larger trial. The study is intended to assess the number of students joining the program and pledging to be smoke-free and to examine changes in tobacco use rates and attitudes following intervention exposure. We hypothesize that the schools will have lower rates of tobacco use and improvement in attitudes, norms and behavioral control over tobacco use after participating in the program.
Primary, secondary, and tertiary specific aims are to answer the following questions about interactive, Internet-based tobacco control intervention directed towards 10th-graders: 1. Smoking Prevention (primary): Does the intervention result in a lower incidence of smoking initiation compared to standard care? 2. Smoking Cessation (primary): Does the intervention result in higher rates of smoking cessation compared to standard care? 3. Reduction of Spit Tobacco Use (secondary): Does the intervention have an impact on spit tobacco use compared to standard care? 4. Stages of Change (tertiary): Does the intervention have an impact on progression through the stages of smoking and spit tobacco acquisition and cessation compared to standard care? 5. Mediating Variables (tertiary): How are mediating variables associated with tobacco-use onset and cessation? 6. Testing Predictors: Investigate established and recently elucidated predictors of susceptibility to smoking at baseline and 12-month follow-up. 7. Develop/Validate Spit Tobacco Measures: Investigate predictors of susceptibility of spit tobacco use at baseline and 12-month follow-up 8. Testing Measures Across Race/Ethnicity: Explore predictors of susceptibility to smoking at baseline and 12-month follow-up to determine whether predictors differ among White, African-American, and Hispanic students.
The purpose of this study was to determine whether a pediatric practice-based smoking prevention and cessation intervention increases abstinence rates among adolescents.
Michigan has the 10th highest smoking rate in the nation. Smoking rates are also very high in the Middle East and in Arab American families. The purpose of this study is to learn about tobacco use in Michigan Arab American youth ages 14 to 18. The study will evaluate why some young people start smoking and others do not. The study will also test an educational program designed to encourage young people to either quit tobacco use or to avoid it.
The goal of this clinical trial is to test a GPS (Global Positioning System)-enabled smartphone app (QuitBuddy) in current smokers. The main questions it aims to answer are: * Is Quitbuddy a good treatment for quitting smoking and "staying quit"? * Will a second treatment that connects people to help for their social and financial needs improve Quitbuddy? Participants will: * get nicotine lozenges in the mail * check in with the study team to report on their quitting progress after 1 day, 1 week, 1 month, 2 months, 3 months, and 6 months Researchers will compare Quitbuddy to an app made by the National Cancer Institute to see if Quitbuddy is better for helping people stay quit.
This is a randomized controlled trial to prevent postpartum smoking relapse by breastfeeding promotion. The intervention group (N=30) will receive multicomponent breastfeeding intervention from late pregnancy to 6 months postpartum, while the attention placebo control group (N=30) will receive general infant care counseling and support. The key outcome is the rate of postpartum smoking relapse.
A small-scale randomized controlled trial (RCT) will pilot test a personalized JITAI designed to guide delivery of fast acting nicotine replacement therapy (NRT; lozenge) in real-time, to prevent smoking relapse. Specifically, a smartphone application (app), will integrate pre-quit smoking data with objective location data captured via global positioning system (GPS) to establish relapse risk (hotspot) algorithms. During a quit attempt, the GPS-enabled app (QuitBuddy) will detect proximity to hotspots and deliver NRT prompts, all of which will occur automatically and prior to exposure. Thus, QuitBuddy will optimize NRT use to prevent cue-provoked cravings known to undermine sustained abstinence, thereby repurposing this evidence-based cessation medication to promote relapse prevention. QuitBuddy will be tested against standard care (NRT with brief instructions). Two versions of QuitBuddy will be tested, which will differ only in how hotspot algorithms are derived: retrospectively from locations recalled at the onset of a quit attempt (QuitBuddy-Recall) or based on real-time EMA completed pre-quit (QuitBuddy).
Tweet2Quit is an innovative smoking cessation intervention that combines real-time online peer-to-peer support with auto messaging. In a three-group randomized controlled trial, the investigators will compare: 1) usual care, 2) Tweet2Quit-coed, and 3) Tweet2Quit-Women only.
Smoking is the main preventable cause of mortality in Western countries, contributing to over 430,000 deaths a year in the U.S. alone. Clinical and epidemiological studies show that women often decrease smoking in pregnancy, when progesterone levels are high. However, at least half resume pre-pregnancy smoking levels within weeks after delivery and when progesterone levels drop. Data from preclinical and clinical studies suggest that progesterone may be effective in preventing relapse to smoking in non-postpartum women. Prior work has shown that progesterone decreases both craving for cigarettes and the subjective rewarding effects of smoking among recently abstinent female smokers. These findings led us to hypothesize that progesterone may have efficacy as a relapse prevention treatment for postpartum women. We propose an 8-week, randomized pilot study to evaluate the safety and initial efficacy of progesterone. This will be a feasibility study that will compare progesterone to placebo for relapse prevention in 40 postpartum smokers. We will assess the feasibility and safety, including the potential effects on breastfeeding and infants exposed via breast milk, in addition to 7-day point prevalence of smoking abstinence after 8 weeks of treatment and at follow-up, 3-months after the end of the protocol.
The purpose of this study is to test different ways to help cancer patients maintain their smoking abstinence. Participants may receive educational materials as part of the study.
We conducted a two-arm (test vs. control, N=160) randomized controlled trial of small, private, online support groups for quitting smoking with 20 people per group who were seeking to quit smoking. A novel feature was a bot (auto-messenger) that posted a daily cessation-related discussion topic in each group, timed to the group's quit date.
A majority of smokers who quit return to smoking within three months of their quit date. This study is a randomized trial to investigate the effectiveness of hypnosis versus behavioural counseling to promote maintenance of abstinence or relapse prevention in quitting smokers. The hypothesis is that hypnosis will be at least as effective as behavioral counseling in preventing relapse to smoking in smokers who are able to quit for at least three days.
This study seeks to determine if continued treatment with bupropion and nicotine replacement therapy (NRT) can reduce the smoking relapse rate in patients with schizophrenia.
The purpose of this study is to determine if exenatide improves end-of-treatment smoking abstinence rates and to determine if exenatide mitigates post-cessation weight gain.
Tobacco use is one of the most significant cancer control and public health challenges in the US today. Half of all smokers in the US will attempt to quit tobacco each year, but fully 95% of those who attempt to quit will reverse this decision within 12 months and choose the transient, albeit immediately rewarding activity of smoking at the cost of much larger long-term rewards such as future health and long life. This project seeks to improve scientific knowledge of these decision-making processes and potentially improve the treatment of tobacco dependence by examining the feasibility of using a brain stimulation technique, repetitive Transcranial Magnetic Stimulation or rTMS to improve the efficacy of an existing evidence-based relapse prevention intervention. rTMS is an FDA-cleared treatment for medication resistant depression and is being examined as a treatment for a variety of other disorders. This study will utilize an intensity and duration of rTMS that is well within the safety parameters and similar in location and intensity to that used in previous studies with smokers to reduce cigarette consumption.
The goal of the proposed study is to validate an experimental paradigm to assess medication effects on smoking relapse following a brief (3-day) monitored period of smoking abstinence and a programmed cigarette lapse.
This study addresses the high risk of weight gain associated with smoking cessation in women. The obesity prevention pilot study is designed for the primary prevention of weight gain that can lead to overweight in normal-weight women, that can progress to obesity in women who are already overweight, and for the prevention of additional weight gain in obese women with BMI greater than or equal to 30.0. Fat and other macronutrient intake, specifically, sugar, complex carbohydrates, and protein, are analyzed as a target for individually tailored, weight control intervention following smoking cessation in Caucasian and African American women.
This two-arm, double-blind, placebo-controlled randomized clinical trial will enroll pregnant women who quit smoking after learning they were pregnant and are motivated to stay abstinent postpartum. Participants will be randomized to receive extended-release bupropion (active 300mg or placebo once daily beginning 4 to 10 days postpartum to 12 weeks post-randomization). All participants will complete the same data collection procedures (e.g., biological sample collection for hormone and cotinine analysis and completion of validated questionnaires) at baseline (gestational week 36), weekly from 4 to 10 days postpartum through 12 weeks post-randomization and at weeks 12, 24, 36 and 52 post-randomization.
The goal of this sub-study is to learn more about how an educational videogame can feasibly be implemented and disseminated in youth programs.
To study feasibility and implementation of a education videogame and the effects on adolescents knowledge and beliefs around tobacco products.
The purpose of this research study is to better understand (1) why people gain weight when they quit smoking and (2) whether certain types of smoking cessation (i.e. quit smoking) counseling combined with the nicotine patch help people quit smoking and gain less weight.
The purpose of this research study is to find out if an investigational drug, GSK598809 can help people who have very recently quit smoking; the investigators want to find out if continuing to take GSK598809 over six weeks can help prevent smokers from relapsing. To relapse means you "fall back" into smoking again after quitting. The investigators also want to find out if GSK598809 is safe to take without causing too many side effects.
The investigators hypothesized that an enriched focus on mother-infant bonding during a newborn's hospitalization in the Neonatal Intensive Care Unit would reduced the rate maternal postpartum smoking relapse and would prolong the duration of breastfeeding in mothers who had quit smoking during or just prior to pregnancy.