View clinical trials related to Tobacco Use.
Filter by:This is a randomized, open-label, 6-way crossover, multi-site study designed to evaluate elements of abuse liability (AL) including subjective effects and physiological measures (pharmacodynamics [PD]), and nicotine uptake (pharmacokinetics [PK]) during and following ad libitum use of the Electronic Nicotine Delivery Systems (ENDS) investigational products (IPs) in generally healthy combustible cigarette (CC) smokers and dual users of CC and ENDS.
While conventional cigarette use continues to decline among youth and young adults, e-cigarette (EC) use is on the rise. Specifically, the investigators will conduct a randomized control trial (RCT) where young adults are randomized to one of two conditions: 1) a regulated ad environment, with high impact EC ad features removed or 2) an unregulated ad environment, with high impact EC ad features left intact. Participants will view EC ads embedded in an online magazine 24 times over the course of 6 months. EC experimentation and sustained use will be the primary outcome of interest.
The purpose of this Actual Use Study (AUS) is to investigate how U.S. adult tobacco consumers 21-60 years of age) who are regular smokers (≥5 cigarettes/day) on at least 20 days out of the past 30 days will use P10 and P13 nicotine pouches (Study Investigational Product [IP]) over a 6-week Actual Use Period (AUP) in their real-life/naturalistic environment and in the context of typical consumer marketing materials. Subjects will self-report their ad libitum use of the Study IP as well as use of combustible cigarette (CC) and any other tobacco- or nicotine-containing product (TNP) on a daily basis using an electronic diary (eDiary). The study design is planned to address topics that FDA's Center for Tobacco Products (CTP) has identified as useful in evaluating new tobacco products.
The overall aim of the study is to explore substance use, tobacco use and lifestyle-related health problems among ageing patients in Opioid Maintenance Treatment (OMT), and other SUD treatment. The study will use already collected data from the multi-center, longitudinal, observational NorComt study (Norwegian Cohort of Patients in Opioid Maintenance Treatment and Other Drug Treatment study). NorComt is the largest longitudinal study of SUD patients in Norway. The data consists of data from OMT and other substance use disorders (SUD) treatment (N=548).
This study is a randomized community-based trial adapted to the needs of adults aged 21 years or older that is designed by an existing research partnership called Communities Engaged and Advocating for Smoke-free Environments (CEASE). The overarching goal of the proposed study is to apply a community-based approach to reduce tobacco use among low-income communities in Baltimore City. The study setting represents three underserved communities in Baltimore City: the Oldtown/Middle East, the Waverlies, Poppleton/The Terraces/Hollins Market, and Washington Village/Pigtown. Poppleton/The Terraces/Hollins Market and Washington Village/Pigtown will be considered as one community. The three communities have been randomly allocated to one of the three arms of the study: 1) Virtual intervention, 2) Enhanced in-person intervention, and 3) The control community. The Waverlies was assigned to virtual, the Middle East was assigned to be the in-person group, and Poppleton/The Terraces/Hollins Market and Washington Village/Pigtown became the self-help/control group. The goal of the trial is to assess the effectiveness of virtual versus in-person versions of a smoking cessation program in terms of their success rates (quitting and staying quit). The study's primary hypothesis is that the smoking cessation rate will be equal to or higher in the virtual peer-motivation arm than the in-person and self-help/ control arms. The secondary hypothesis is that the retention rate will differ among the three interventions (virtual peer-motivation, enhanced in-person peer-motivation, and self-help/control community). Virtual and enhanced in-person versions of the CEASE Today Peer-Motivation Intervention were developed and pilot-tested during the first and second years based on local data and input from partnering communities. The enhanced in-person intervention will utilize the existing CEASE Today Tobacco Cessation Manual with improvements. The virtual intervention will use a newly developed CEASE website with smoking cessation modules and lessons that mirror the CEASE Today Tobacco Cessation Manual. Trained peer-motivators will deliver the intervention and be actively involved in recruiting the participants, motivation enhancement, group facilitation, and counseling.
The primary objective of this study is to conduct a 3-arm randomized controlled trial (RCT) that compares the effectiveness of three multi-component interventions that are embedded in HIV outpatient clinics (OPCs): 1)3As+Referral to the national quitline: Ask about tobacco use, Advise to quit, Assist with brief counseling and Refer to Viet Nam's national Quitline; 2) AAA+ +Counsel (Counsel=6-session cessation counseling intervention adapted for patients living with HIV/AIDS (PLWH) and delivered by a trained, onsite nurse; and 3) AAA+Counsel+N (N=nicotine replacement therapy (NRT)). The main outcome is biochemically validated 6-months smoking abstinence. The investigators will recruit and randomize 672 patients across 13 outpatient clinics (OPCs) (48 per site, 16 per arm). The investigators will also recruit 75-nonsmokers to participate in a single survey to assess food safety. Therefore, the total sample = 747 patients.
This is a randomized, controlled, multi-center, open-label, 8-cohort parallel group study to assess changes in select biomarkers of exposure (BoE) and biomarkers of potential harm (BoPH) in generally healthy smokers switching to the study investigational products (IPs), compared to subjects who continue to smoke, undergo smoking abstinence, or have never smoked.
This is a two-site, open-label, randomized, 5-way cross-over study designed to evaluate elements of abuse liability (AL) including subjective effects and physiological measures (pharmacodynamics [PD]) and plasma nicotine uptake (pharmacokinetics [PK]) during and following ad libitum use of the study investigational products (IPs) by generally healthy smokers.
This study continues an adaptation of care coordination to address the needs of women after preterm birth. This is a small single arm open trial designed to test intervention implementation and refine the intervention before ongoing feasibility testing.
This research project will explore the feasibility and acceptability of a web-based media literacy tobacco prevention program. The project will be conducted with 9th or 10th graders in two high schools in Pittsburgh, Pennsylvania.