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Tobacco Use clinical trials

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NCT ID: NCT04284813 Completed - Schizophrenia Clinical Trials

Families With Substance Use and Psychosis: A Pilot Study

Start date: September 24, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to develop and evaluate an intervention that adapts Community Reinforcement and Family Training (CRAFT) for families experiencing first episode psychosis and substance use delivered via telemedicine (video conferencing). The intervention aims to improve treatment engagement and reduce distress, and it will be delivered via telemedicine (CRAFT-FT). To assess feasibility of the intervention, family members will complete the sessions and provide feedback to refine the treatment manual. Data on client relatives with psychosis will be collected for preliminary assessment purposes. Client relatives will not complete the research study intervention.

NCT ID: NCT04259749 Completed - Tobacco Use Clinical Trials

Testing Legally Feasible Options: Study 1

Start date: January 16, 2020
Phase: N/A
Study type: Interventional

The overall aim of this research is to experimentally evaluate different, legally-viable approaches to reducing the impact of the point-of-sale (POS) retail environment on adolescent tobacco use risk. This study will be investigating the regulations for four classes of tobacco products (cigarettes, e-cigarettes, smokeless tobacco, little cigars/cigarillos). Study 1 (study 1 out of 3 proposed) will examine whether eliminating the sale of flavored tobacco products at POS reduced adolescents' tobacco use risk.

NCT ID: NCT04238832 Completed - Smoking Clinical Trials

Salt-Based E-cigarette

Start date: June 16, 2020
Phase: N/A
Study type: Interventional

Electronic nicotine delivery systems (ENDS) vary on a wide range of characteristics, which may impact the reinforcement value of the products compared to more harmful combustible products. A new type of low-powered ENDS device has surged in popularity-the pod system. Pods use nicotine salt e-liquids, rather than free-base nicotine solutions that have been used in other ENDS device types. Manufacturers claim that these formulations reduce the harshness of nicotine delivery, while still delivering sufficiently high levels of nicotine. However, the role of nicotine salts in the popularity and use of pod systems remains unclear because no studies have directly manipulated and examined the role of nicotine formulation (salt vs. free base) in reinforcement value and use. The primary purpose of the proposed study is to assess the impact of nicotine formulation (nicotine salt vs. free-base) in reinforcement value and tobacco use. Current smokers (n=30) will complete a one-week baseline period where they smoke as normal before attending an in-person lab visit during which they will sample a traditional cigarette and two ENDS products (nicotine salt ENDS, free base ENDS). All aspects of the device will be held constant other than the nicotine formulation (including nicotine concentration, flavor options, device brand). Participants will answer questionnaires about each product they sample and then complete a preference assessment in which they choose between the products they sampled and their own cigarette. Finally, participants will be assigned to take one of the products they sampled home to use ad libitum (1-week sampling). During the at-home baseline and sampling weeks, participants will complete electronic daily diaries cataloging their tobacco use. Biomarkers (i.e., expired carbon monoxide, cotinine) will corroborate self-reported indices of use.

NCT ID: NCT04237272 Completed - Smoking Clinical Trials

JUUL vs. Mod E-cigarette Study

Start date: November 15, 2019
Phase: N/A
Study type: Interventional

Some smokers who try e-cigarettes transition completely from cigarettes to e-cigarettes, but others continue to use both products, or abandon e-cigarettes and return completely to cigarettes. One factor that likely impacts these tobacco use patterns is the e-cigarette device used. The majority of e-cigarettes purchased today are one of two "types:" customizable tanks or pods. These e-cigarette types differ from each other in critical ways, like nicotine delivery and sensory characteristics, that are likely to impact use by influencing the relative reinforcement value of the product. The present study will be a randomized trial investigating the impact of e-cigarette device type on reinforcement value and use among current smokers. Current smokers (n=100) will be randomly assigned to either a control group that does not receive an e-cigarette or one of two e-cigarette types: a customizable tank, or a pod. The impact of device type on relative reinforcement value will be assessed using a choice task. Participants will also take home their assigned e-cigarette for a three-week sampling period. Primary outcomes include relative reinforcement value (choices to smoke in the lab-based choice task), cigarette smoking behavior (cigarettes smoked per day during sampling), and uptake (e-cigarette puffing episodes per day during sampling).

NCT ID: NCT04226404 Completed - Smoking Clinical Trials

CSD190501: A Study to Determine Subject Puffing Patterns of an Electronic Nicotine Delivery System in an Ambulatory Setting

Start date: January 14, 2020
Phase: N/A
Study type: Interventional

This study will be a single-center, controlled, open-label, parallel study to evaluate the puffing patterns of healthy adult consumers of tobacco products switching from a usual brand (UB) Electronic Nicotine Delivery Systems (ENDS) product to an ENDS Investigational Product (IP) product with 4.8% nicotine over a three-week ambulatory period. This study will be conducted in support of a Premarket Tobacco Product Application (PMTA) ENDS submission to the US Food and Drug Administration (FDA) Center for Tobacco Products (CTP).

NCT ID: NCT04167384 Completed - Smoking Clinical Trials

CSD190301: A Study to Assess Elements of Abuse Liability for Two Dissolvable Nicotine Lozenge Tobacco Products

Start date: December 2, 2019
Phase: N/A
Study type: Interventional

This is a two-arm, single use, single-center, randomized, 10-sequence per arm, open-label, crossover pharmacokinetic/pharmacodynamic (PK/PD) study, designed to evaluate elements of abuse liability (AL) including subjective effects, plasma nicotine uptake, and physiological measures during and following ad libitum use of the study investigational products (IPs) by generally healthy subjects.

NCT ID: NCT04143256 Completed - Tobacco Use Clinical Trials

Evaluating Selected Constituents in the Exhaled Breath Samples

Start date: October 3, 2019
Phase: N/A
Study type: Interventional

An Open-Label, Multi-Center Study to Evaluate Selected Constituents in the Exhaled Breath Samples From the Use of JUUL Nicotine Salt Pod System Product (5% and 3% Virginia Tobacco, Mint, Mango, Menthol) Users and Conventional Cigarettes (Non-Menthol and Menthol Flavors)

NCT ID: NCT04107779 Completed - Tobacco Use Clinical Trials

Changes in Biomarkers of Cigarette Smoke Exposure After Switching Either Exclusively or Partly to JUUL ENDS

Start date: September 17, 2019
Phase: N/A
Study type: Interventional

A Randomized, Open Label, Parallel Group Study in Adult Smokers to Evaluate Changes in Biomarkers of Cigarette Smoke Exposure After Switching Either Exclusively or Partly to using JUUL Electronic Nicotine Delivery Systems With Two Different Nicotine Concentrations

NCT ID: NCT04104152 Completed - Smoking Clinical Trials

CSD190203: A Study to Determine Subject Puffing Patterns of an Electronic Nicotine Delivery System in an Ambulatory Setting

Start date: October 7, 2019
Phase: N/A
Study type: Interventional

This study will be a single-center, randomized, controlled, open-label, parallel 2-cohort study to evaluate the puffing patterns of individuals switching from a similar usual brand (UB) Electronic Nicotine Delivery System (ENDS) product to either a 2.4% or 5% nicotine level ENDS product in healthy adult ENDS users. This study will be conducted for potential submission to the US Food and Drug Administration (FDA) Center for Tobacco Products (CTP) as part of a Premarket Tobacco Product Application (PMTA) for an Electronic Nicotine Delivery System (ENDS), comprised of an electrical power unit and four flavor variants each with two different levels of nicotine (2.4% and 5.0%).

NCT ID: NCT04094363 Completed - Smoking Clinical Trials

CSD190202: Study to Assess Elements of Abuse Liability for Two Electronic Nicotine Delivery Systems

Start date: October 3, 2019
Phase: N/A
Study type: Interventional

This is a randomized, open-label, crossover study designed to evaluate elements of abuse liability (AL) including subjective effects, plasma nicotine uptake, and physiological measures during and following ad libitum use of the investigational products (IPs) by healthy subjects.