540 Clinical Trials for Various Conditions
The overall purpose of this pilot study is to assess the feasibility and acceptability of an in-person faith-based intervention to help people stop tobacco use. The study will address use of different types of tobacco products, such as smoking combustible cigarettes, cigarillos and little filtered cigars, and using/vaping electronic nicotine delivery systems (vape pens, e-cigs, and JUUL). The intervention consists of 12 weekly meetings in which participants will go through BREATHE Free, a study guide curriculum designed to teach character strengths and promote resilience. This pilot research will provide information and practical lessons on how to improve Breathe Free implementation, increase engagement of the local people, and maximize their benefit. The main questions it aims to answer are: * Do participants find BREATHE Free curriculum acceptable, engaging and helpful to stop tobacco use? * Do participants who complete BREATHE Free curriculum smoke fewer cigarettes per day? Researchers will assign participants to either BREATHE Free curriculum or usual care. Participants will: * Be taught BREATHE Free curriculum or be given information and referral to tobacco quit line * BREATHE Free group will attend 12 group meetings held on the university campus * All participants will answer interview questions related to tobacco use, character strengths and resilience * Expired Carbon Monoxide (CO) will be assessed in all participants.
This research study, conducted by Truth Initiative, will help us learn how text messaging can help adolescents between 13 and 17 years of age quit vaping.
This study aims to investigate the benefit of administering two differing doses of Bupropion (BUP) to smokers to assist with smoking cessation.
The proposed project will test the effectiveness of the novel delivery of an established tobacco cessation treatment among pregnant women in Kentucky. Tobacco use during pregnancy is one of the most modifiable risk factors associated with poor birth and maternal outcomes and yet smoking prevalence among pregnant women in Kentucky is among the highest in the county and estimated to be twice that of the national average, with no meaningful declines observed in twenty years.
The purpose of this study is to evaluate the feasibility, acceptability and preliminary efficacy of a Scheduled Gradual Reduction (SGR) intervention via Short Message Service (SMS) text messaging plus SMS Support Messages in decreasing smokeless tobacco use in a rural population.
All participants will receive the EnufSnuff.TXT scheduled gradual reduction (SGR) intervention for 6 weeks and, for those who do not reach the point of quit, includes getting randomized (like the flip of a coin) into either an additional 8-10 weeks of the EnufSnuff.TXT intervention or into receiving an additional 8-10 weeks of the EnufSnuff.TXT intervention along with a dedicated text quit coach to send and receive live support.
In low-income housing units in Baltimore, the investigators propose to conduct a pilot two-arm hybrid type 1 effectiveness-implementation RCT comparing a) an avatar-delivered computerized intervention (CI) for tobacco cessation augmented with CHW support and navigation to lung cancer screening to b) a waitlist control. With a sample of participants from public housing units (N=30), the investigators will collect data on feasibility of recruitment, intervention engagement and completion, and short-term smoking cessation outcomes. Individuals will be assessed at baseline, 1 month, 3 months, and 6 months. At the 3-month time point, the investigators will conduct interviews with a subset of pilot participants to collect qualitative data on intervention acceptability.
Tobacco use is the leading preventable cause of death in the US, contributing to more than 480,000 premature deaths each year. The Tobacco Treatment Guidelines underscore the need to offer patients who use tobacco products brief interventions that include prescriptions for proven pharmacological smoking cessation aids and proactive connections to evidence-based behavioral support. The rapid expansion of smart phone capabilities enhances the potential for tobacco cessation apps to personalize behavior change guidance and to send contextually relevant tailored behavior change nudges based on readiness to quit and electronic heath record (EHR) data. Rich data from EHRs are now available to third-party apps from the Health app (iOS) via Fast Healthcare Interoperability Resources standard Application Programming Interface (API). This Phase I Small Business Innovation Research (SBIR) explored the effects of one such innovative health IT solution. refresh is a highly individualized tobacco cessation HealthKit enabled app that 1) implemented a full range of best practices in tailored health behavior change communications based on readiness to change; 2) provided individualized behavior change guidance based on Health app data; and 3) concisely provided data and documentation of key actionable insights in the EHR on the patient's smoking status, app usage, and brief micro-message delivered by clinicians to reinforce and accelerate a patient's behavior change progress. This interoperability provided value to both patients and clinicians; empowered and supported successful and lasting behavior change; and enabled the implementation and evaluation of a best-in-class approach to tobacco and nicotine treatment. Extensive end user and stakeholder input ensured that refresh was designed for rapid dissemination. Patients of an integrated delivery system with an upcoming appointment (n=51) were recruited to participate in a 30-day pilot test. Pre-post comparisons of Patient-Reported Outcomes Measurement Information System (PROMIS) measure for tobacco (psychosocial expectancies) and confidence for quitting provided preliminary data on the effects of the program. The hypothesis was that the patients who utilize refresh will have significantly higher psychosocial expectancies regarding tobacco at follow-up and greater confidence to quit smoking.
To inform a future randomized trial of a virtual counselor led computer delivered intervention for tobacco cessation augmented with community health worker (CHW) support and navigation to lung cancer screening in low-income housing units in Baltimore, the investigators propose to collect data on intervention acceptability and feasibility among individuals in public housing as well as feedback on use of shared decision making when referring for low-dose chest CT (LDCT). The investigators will conduct a feasibility pilot study of a virtual counselor plus community health worker intervention. With a sample of participants from public housing units (N=15), the investigators will collect data on feasibility of recruitment, intervention engagement and completion, and short-term smoking cessation outcomes. Individuals will be assessed at baseline, 1 month and 3 months. At the end of three months, the investigators will conduct follow up interviews with a subset of pilot participants to collect qualitative data on intervention acceptability. Based on this information, the investigators will make iterative improvements to the combined intervention.
At the Fire Department of the City of New York (FDNY) World Trade Center Health Program, 36% of participants in the low dose computed tomography (LDCT) lung cancer screening program are current smokers, despite referral to the free FDNY Tobacco Cessation Program (Standard Care). Investigators propose testing an Enhanced Care program which includes opt-out enrollment; tobacco cessation counseling will be individually tailored to spirometry/LDCT results and treatment with varenicline starting 4 weeks prior to their target quit date. This randomized trial will compare enrollment and cessation outcomes in Standard Care vs. Enhanced Care groups of challenging-to-treat, high-risk smokers.
The intersection of smoking and HIV/AIDS poses a serious public health threat in Vietnam. Vietnam is dealing with these two challenges with parallel rather than integrated plans. Using a computer-tailored texting intervention, study investigators seek to promote the use of an underused, available, government-funded resource (the Quitline) and Nicotine Replacement Therapy (NRT) that the quitline provides, thus, promoting cessation among PLWH.
This is a multi-arm, randomized controlled, pilot study which will recruit cancer patients who have been seen by a UCSF Cancer Center-affiliated clinical department to evaluate the efficacy of "CareConnect". This is the first study to assess the efficacy CareConnect, a combination of the Ask-Advise-Connect (AAC) with an Interactive Voice Response (IVR) delivering cancer-targeted educational messages to support referral to smoking cessation resources for patients with cancer.
This study will evaluate the compliance with a daily kava regimen among active smokers who have an intention to quit smoking. This study will also investigate whether kava use can facilitate tobacco cessation, reduce stress, and improve sleep.
The purpose of this research study is to learn how best to incorporate tobacco cessation treatment into clinical care for cancer patients, survivors, and caregivers.
The goal of this research study is to test an intervention to help quit tobacco use in participants with Human Immunodeficiency Virus (HIV). The study interventions used in this research study are: * Positively Smoke Free - Mobile (PSF-M) (mobile behavioral program) * Varenicline (or Chantix, apovarenicline, Champix or Nocrav)
This research study is being conducted to test the effectiveness of the Enhanced Multicomponent Proactive Navigator-Assisted Cessation of Tobacco Use (EMPACT-Us), an innovative suite of tobacco cessation services designed in partnership with patients, providers, and other community stakeholders during a pilot study. We hypothesize that EMPACT-Us will be more effective than the newly-enhanced usual care on improving engagement in tobacco treatments, quit attempts and biochemically verified cessation at 6-and 12-months post initial offerings.
Cigarette smoking is the leading cause of death and disability in the United States. People with psychiatric disorders consume almost half (44.3%) of all cigarettes smoked in the U.S. and have life spans more than 20 years shorter than the general population. Effective quit smoking treatments for people with psychiatric disorders are sorely needed. When patients are hospitalized for a psychiatric disorder, they are not allowed to smoke. This enforced period of no smoking creates what professionals call "a teachable moment". It provides an excellent opportunity to discuss the prospect of staying quit once the individual leaves the hospital. In ongoing research, the investigators have developed and tested a Sustained Care quit smoking intervention for smokers engaged in a psychiatric hospitalization. The intervention includes: 1) a professionally-led, motivational counseling session to encourage quitting smoking and increase awareness about available quit smoking resources, 2) a referral to the Texas Tobacco Quitline for phone-based, quit smoking counseling, and 3) an offer of 8 weeks of nicotine patches after leaving the hospital. Findings from a recently completed clinical trial provide strong support for this Sustained Care intervention. Aims in the current project are to develop and test a tablet computer-based, motivational counseling intervention that does not require a trained professional counselor. The goal is to conduct a clinical trial to demonstrate the effectiveness of this tablet-based, Sustained Care intervention for smokers engaged in psychiatric hospitalization. As before, the same quit smoking resources (Quitline and nicotine patches) will be provided upon hospital discharge. If successful, next steps will involve plans to implement this quit smoking intervention in psychiatric hospitals throughout Texas, in order to reduce the burden caused by tobacco-related cancers among the citizens of Texas.
Tobacco cessation treatment is needed for individuals with peripheral artery disease (PAD) to improve symptoms, lower cardiovascular risk, and prevent amputation. While such treatment is effective, many PAD patients do not receive cessation therapy. Participants will receive nicotine replacement therapy, counseling, and and complete questionnaires. We hypothesize that integrating tobacco cessation services into a dedicated PAD clinic (OU CVI Limb Preservation Clinic) can improve tobacco cessation rates and improve PAD-related health outcomes in this at risk population.
Cannabidiol is a compound found in cannabis plants that is well tolerated, has low abuse liability, and might be an effective medication to promote tobacco cessation. This clinical study will use a validated approach for screening tobacco cessation medications to determine if oral cannabidiol increases short-term tobacco abstinence, and evaluate mechanisms that might explain how cannabidiol alters smoking behavior. Results from this study will provide data on the therapeutic potential of cannabidiol for tobacco cessation.
Sexual and/or gender minority (SGM) people have disproportionately high rates of tobacco use - the number one cause of preventable death. Reasons for this include using tobacco to cope with social minority stressors, pro-tobacco use norms in SGM social spaces and networks, and targeted tobacco industry marketing. Empowerment Theory explains how positive behavior change, like quitting smoking, can be promoted through skills development with greater participation in the public affairs of one's community. An empowerment approach may enhance tobacco cessation treatment for SGM people and other stigmatized groups because it links individual well-being with the larger social and political context. This pilot study will assess the acceptability, feasibility, and preliminary impact of empowerment-enhanced tobacco smoking cessation assistance for SGM adults. We will enroll N=20 SGM adults in Oklahoma who smoke and are willing to quit. Participants will receive standard tobacco cessation assistance through the Stephenson Cancer Center Tobacco Treatment Research Program (TTRP). Concurrently, they will also engage in 'empowerment activities', meaning SGM organizing and community-building activities, like conducting follow-up phone calls to name change clinic participants. This will be guided by an Oklahoman SGM-serving community partner. Participants will complete 8 surveys during the intervention period and 12 weeks post-quit-date, a 60-minute, in-depth exit interview, and biochemically-verified smoking status before the intervention and 12 weeks post-quit-date. This pilot study will establish collaborative relationships between the PI's team and local SGM-serving organizations, and will produce preliminary findings to support future R01-level funding to conduct a fully-powered randomized control trial of a multi-level empowerment-enhanced SGM tobacco cessation intervention.
The present study is a 3-arm randomized controlled pilot study. Participants who call the Maryland Tobacco Quitline and are eligible for study participation are randomized to receive quitline tobacco cessation treatment as usual (TAU), TAU plus remote carbon monoxide (CO) monitoring via smartphone app, or TAU plus remote carbon monoxide monitoring plus incentives vis smartphone app. The investigators hypothesize that remote CO monitoring will be feasible and acceptable to deliver in the quitline setting, will increase treatment engagement, and will increase tobacco cessation and treatment satisfaction rates.
The objective of this R01 application is to conduct a randomized controlled trial to test the efficacy of the Be Smoke Free, telephone-based, guided imagery (GI) intervention (IC) for smoking cessation compared to active behavioral control (CC). The study will recruit 1,200 diverse smokers from three states, Arizona, New York, and West Virginia to increase generalizability. Participants will be randomly assigned to receive either the IC or CC delivered by telephone by University of Arizona study coaches and will be assessed at 3- and 6-months post-enrollment by study staff. The primary outcome is biochemically verified 7-day point prevalence abstinence at 6 months. This innovative and rigorously designed project conducted by an experienced team has the potential to improve public health through the delivery of an innovative integrative GI intervention via telephone.
There are significant barriers to tobacco cessation treatment for patients and providers in specialty care clinical settings. Specialty providers cite several barriers to delivering evidence-based tobacco cessation care, including insufficient time and lack of training. In addition, a large proportion of patients who begin tobacco cessation treatment do not quit. Use of healthcare technology (i.e., telehealth, electronic health record, and computerized treatment algorithms based on patient data) to improve patients' ability to quit tobacco use. The purpose of this study is to demonstrate the feasibility of a larger trial, and to evaluate the acceptability of the intervention design. Thirty participants will be assigned to receive either 1) a treatment that includes personalized counseling, tobacco cessation medications, and text messaging; or 2) referral to Department of Veterans Affairs' Quitline program plus SmokefreeVET, a text messaging program.
The investigators have developed a hybrid computer- and person-delivered intervention, called "C-Raven" for smoking cessation that is tailored to people with tobacco use in Baltimore City. The computer delivered component consists of two \~20 minute sessions on an iPad guided by Edna Poe, an interactive avatar. These sessions are followed by elective in vivo initiation of nicotine replacement therapy (NRT). Community health workers (CHWs) trained in smoking cessation and motivational interviewing provide 6 weeks of supportive follow up counseling. The investigators propose a pilot of the intervention package in the Tobacco Treatment and Lung Cancer Screening Clinic (TTLCSC) at Johns Hopkins Hospital, and the Johns Hopkins Broadway Center for Addiction, assessing feasibility and acceptability of using this tool in these clinical settings. In addition, the investigators will compare whether the use of a virtual counselor is associated with greater satisfaction and engagement with the program. To this end, the investigators propose a two-arm randomized controlled trial, randomizing up to 90 individuals with tobacco use to the current CRAVEN program which includes a virtual counselor, to CRAVEN without a virtual counselor. Primary outcomes include intervention feasibility and acceptability. The investigators will secondarily examine uptake and maintenance of pharmacotherapy for tobacco cessation, readiness to quit smoking, and tobacco cessation (7 day abstinence) at 6 months, patient satisfaction by intervention arm and CHW engagement by intervention arm.
The investigators are asking professional firefighters across North Carolina to take part in focus groups to discuss the specific needs of firefighters in smokeless tobacco cessation. About 40 firefighters will take part in the focus groups. The purpose of the focus groups is to learn how firefighting and shift work impact smokeless tobacco use and risk perceptions related to chew or dip. Using their feedback, the study team will then develop a cessation program specifically geared towards firefighters and first responders. The cessation program will be a mobile text / chat intervention specifically tailored to needs of firefighters and first responders who wish to stop using smokeless tobacco. About 50 firefighters and first responders will take part in this program, while being randomized into either the intervention group or the control group.
The proposed pilot study aims to develop and test a patient video educational tool, an interactive Mobile Doctor (iMD), that can be integrated in radiation oncology setting to effectively engage cancer patients receiving treatment at University of California, San Francisco (UCSF) to facilitate smoking cessation and maintaining smoking abstinence in the context of their radiation treatment. This study is the first to address tobacco use among can patients receiving radiation therapy that targets both tobacco cessation (current users) and maintaining abstinence (former users who have recently quit).
The inequity in cessation resources is at forefront in the recently enacted nationwide smoking ban in public housing facilities. The critical component lacking from the federal decree was a practical smoking cessation strategy to address the real-world needs of active smokers who maintain cigarette usage. The investigator's proposal is ideally situated for this contemporary moment when low-income smokers in public housing are signing leases describing the potential for smoking-related evictions and thus at least contemplating smoking modification. The investigator's project is centered around the residents of Baltimore City Public Housing which is among the larger-sized U.S. public housing agencies. Using a human-centered design (HCD) approach, the investigators are refining and testing a community-centric cessation strategy defined by two core elements: a) durable and jointly linked community/hospital infrastructure systems (remote cessation specialist staffing and drug supplies) and strong on-site (public housing) residential leadership commitment to cessation improvement. These dual features, along with adaptable elements that can be modified to a variety of local/national housing settings, defines how the investigator's project will overcome the implementation gaps defining failed smoking cessation efforts in lower-income settings. The objective of this project is to test the feasibility of the intervention package among local housing contextual factors that could impact both the acceptability and adoptability of the investigator's project. Using a collection of formative and implementation evaluation measures, the investigator's academic-community partnership project is well positioned to create an adaptable and customizable intervention that can be scaled in similar housing populations.
Tobacco and cannabis co-use is a common and growing public health problem, especially in states that have legalized cannabis. There are no pharmacologic treatments for co-occurring tobacco and cannabis use. Co-use may make quitting either substance more difficult, given the synergistic effects of cannabis and nicotine on neurobiological systems that mediate reward and shared cues reinforcing co-use. N-acetylcysteine (NAC), an FDA-approved medication and over-the-counter supplement, has shown promise in animal studies and randomized controlled trials (RCTs) in reducing tobacco and cannabis craving and use.
Participants will be randomly assigned (like the flip of a coin) to one of the two groups after completing the baseline survey. Participants have a 50% of being in either the #EnufSnuff.TXT intervention group or the Enough Snuff Intervention group. Participants will then be given a baseline survey and the intervention will be explained to them.
People with serious mental illness are three times more likely to smoke cigarettes than people without mental illness. People with mental illness are less likely to be successful in quitting smoking than those without mental illness. Therefore, the healthcare community needs to find ways to get people with mental illness treatment to help them stop smoking. This study explores whether a treatment, called acceptance and commitment therapy, which is an affective therapy for serious mental illness, can help patients with serious mental illness stop smoking. In particular, the investigators test whether patients will be interested in receiving acceptance and commitment therapy for smoking cessation in a psychiatric partial hospital (also known as a day treatment program), whether they are able to complete the treatment, and whether it will help them stop smoking compared to usual care. To test these research questions, 40 patients in the Rhode Island Hospital's psychiatric partial hospital will be recruited. Half of the patients will receive acceptance and commitment therapy to help them stop smoking (2 in person sessions, 5 telephone sessions) and half will receive usual care (2 in person sessions, electronic referral to the Rhode Island tobacco quit line). All participants will be offered the nicotine patch. All participants will complete a baseline survey and a follow-up visit at the end of treatment to measure whether they stopped smoking and whether they liked the treatment. The study will also measure how many participants completed the treatment sessions. If successful, this treatment model could be a way to get more patients with mental illness into treatment.