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Tobacco Smoking clinical trials

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NCT ID: NCT03272685 Completed - Nicotine Dependence Clinical Trials

Impact of Very Low Nicotine Content Cigarettes in a Complex Marketplace

Start date: June 1, 2018
Phase: Phase 3
Study type: Interventional

This project will examine the impact of very low nicotine content (VLNC) cigarettes in a complex tobacco and nicotine product marketplace. We will compare the number of cigarettes smoked and cigarette-free days in an experimental marketplace that contains VLNC cigarettes versus normal nicotine content (NNC) cigarettes.

NCT ID: NCT03268980 Completed - Tobacco Smoking Clinical Trials

Smoking Prevalence at a University Hospital

TABAC-HCL
Start date: November 23, 2017
Phase:
Study type: Observational

- Tobacco is the leading risk factor for avoidable mortality in France and around the world. It is also the second cause of life with disability in the world and the leading preventable risk factor for cancer in France and worldwide. - The "Health Barometer" studies carried out for 25 years in France by Santé-Publique France assessed prevalence of smoking in the lay population. These studies showed that smoking prevalence has stabilized among 15-75 year olds (34.1% of current smokers) with a slight decrease in regular smoking (from 29.1% in 2010 to 28.2% in 2014). - Data on the prevalence of smoking among hospital staff are contradictory. Some studies find a higher prevalence of active smoking than the general population; others have a lower prevalence. However, it appears that an active prevention policy with hospital staff can significantly and rapidly reduce the prevalence of active smoking. - The prevalence of active smoking in patients is logically higher than in the general population (at comparable age). - The data on the prevalence of smoking among medical students are also contradictory. Yet, this population is a special interest group given their future investment in patient care. - Cannabis use also appears to be an independent risk factor for respiratory diseases and broncho-pulmonary cancers. Cannabis use among health students is not uncommon (11.5% of students). To our knowledge, the measurement of the prevalence of Cannabis use in an all-patient population of a hospital-university facility has never been achieved. - According to the health barometer 2014, about a quarter of 15-75 year olds have already tried electronic cigarettes and 6% are regular current users. Although the toxicity of the electronic cigarette and its interest in weaning remain controversial, its use to patients, staff or patients has been reported very little. The aim of this study is to assess the impact of collective and individual tobacco control measures by measuring the prevalence of smoking on a given day at the "Hospices Civils de Lyon", among patients, staff and students present on a given day.

NCT ID: NCT03262662 Completed - Tobacco Smoking Clinical Trials

EVarQuit: Extended Pre-quit Varenicline to Assist in Quitting Smoking

EVarQuit
Start date: October 1, 2017
Phase: Phase 3
Study type: Interventional

Varenicline is the most effective smoking cessation therapy available. Nevertheless, most smokers using varenicline relapse within the first few months after quitting. Varenicline is hypothesized to help smokers to quit in part by reducing the reinforcing effects of smoking during the standard 1-week pre-quitting treatment phase. Learning theory and previous human and animal research support the hypothesis that a longer period of varenicline treatment prior to the target quit date (TQD) will lead to greater reductions in smoking before quitting, and higher long-term cessation rates, compared to standard varenicline treatment. Building on promising preliminary clinical data, the study tests these hypotheses with a full-scale randomized clinical trial (RCT). 320 treatment-seeking smokers will be randomized to a standard run-in group (3 weeks of placebo, followed by the standard 1 week of pre-TQD varenicline) or an extended run-in group (4 weeks of pre-TQD varenicline). Both groups will receive brief individual cessation counseling and 11 weeks of post-TQD varenicline. The primary outcome measure will be bio-verified continuous abstinence at end-of-treatment (weeks 8-11 post-quit; cessation at 26-weeks post TQD will also be examined. Hypothesized mediating mechanisms (e.g., smoking reinforcement) will be evaluated by behavioral, physiological, and subjective measures assessed both in the lab and using real-world, real-time electronic momentary assessments (EMA). The investigators predict that long-term, bio-verified smoking cessation will be improved among the extended run-in group compared to the standard run-in group. The investigators further predict the improved clinical outcomes with extended run-in varenicline will be explained (or mediated) by greater pre-quit reductions in smoking reinforcement among the extended run-in group compared to the standard run-in group. The significance of this work is clear: The project aims to make best available treatment for smoking cessation even better, using a method that is ripe for dissemination and an approach that will elucidate critical mechanisms to target in the next generation of treatment enhancement.

NCT ID: NCT03259360 Completed - Smoking Cessation Clinical Trials

A Facebook Intervention for Young Sexual and Gender Minority Smokers

POP
Start date: April 23, 2018
Phase: N/A
Study type: Interventional

The 2-year research plan will test the Put It Out Project (POP) in a pilot randomized trial (N=120) compared to TSP and two historical control conditions. Participants will be young adults who smoke, identify as sexual or gender minorities, and use Facebook. The primary outcome will be biochemically verified 7-day abstinence from smoking at 3 and 6 months. Secondary outcomes will be a quit attempt (y/n), stage of change, and thoughts about tobacco abstinence at 3 and 6 mos.

NCT ID: NCT03238456 Completed - Smoking Cessation Clinical Trials

Smoking Cessation for Young Adult Pacific Islanders: Motivating Pacifika Against Cigarettes and Tobacco

MPACT
Start date: July 11, 2013
Phase: N/A
Study type: Interventional

The current study aimed to test a culturally tailored program designed to help Pacific Islanders (PIs) between the ages of 18 and 30 quit smoking cigarettes by using a randomized controlled trial design with one intervention group and one control group.

NCT ID: NCT03213418 Terminated - Smoking Cessation Clinical Trials

Electroretinogram: a New Human Biomarker for Smoking Cessation Treatment

Start date: February 1, 2018
Phase: N/A
Study type: Interventional

This project aims to develop electroretinogram as a new putative marker for dopamine release, and as a predictor of treatment response among patients seeking treatment for smoking cessation. Tobacco smoking continues to be a major public health challenge. Dopamine is a neurotransmitter released in the brain. Several lines of evidence suggest that dopamine release deficit in the brain is involved in the development and maintenance of nicotine dependence. The investigators hypothesize that smokers who do not have a deficit in dopamine release will more readily respond to behavioral treatment for smoking cessation, and in particular, financial incentives contingent on abstinence (Contingency Management). Previous pilot data suggest electroretinogram (ERG), which records electrical signals from the retina in response to light, is a clinically accessible correlate to dopamine release in the brain. The project proposes an ERG-based biomarker, and a pilot clinical trial to apply this biomarker to personalize smoking cessation treatment. This clinically tractable biomarker of central dopamine release may have a large number of future applications in the diagnosis and treatment of other mental illnesses and substance use disorders. The study will recruit normal controls and smokers, measure ERG before and after a standard dose of oral immediate release methylphenidate. Smokers will undergo a 12-week standardized treatment course of CM. The investigators will test whether smoking status and the response to CM are correlated to changes in ERG in response to methylphenidate challenge.

NCT ID: NCT03196102 Completed - Nicotine Dependence Clinical Trials

Evaluation of a Brief Tobacco Intervention in the US Military

Start date: April 5, 2017
Phase: N/A
Study type: Interventional

While the military has taken steps to reduce tobacco use over the past two decades, over a quarter of new military recruits report regular tobacco use prior to enlistment. This rate is higher than the national prevalence of 21.3% of US adults. Brief health prevention programs may be particularly effective for Airmen in Technical Training, given that all Airmen have been tobacco free for 11 ½ weeks and nearly 2/3rds are confident that they won't return to tobacco. We have developed and validated a Brief Tobacco Intervention (BTI) that is currently being implemented as part of Technical Training. We found that a motivational interviewing based, 40 minute BTI was efficacious in increasing perceived harm and decreasing intentions to use tobacco in a sample of 1055 Air Force trainees. Although we obtained significant positive changes in latent cognitive constructs for tobacco behavior that are highly predictive of future tobacco use in youth and young adults, the Little et al study did not obtain measures of actual tobacco resumption following the ban on tobacco in Air Force training. Given that 69.8% of all tobacco resumption/initiation occurs in Technical Training, a study that evaluates the short-term impact of our BTI on actual tobacco use is necessary prior to conducting the full scale R01 that would evaluate the long term efficacy of the BTI intervention. Thus, we propose the following Specific Aims: (1) To recruit approximately 2,000 Air Force trainees at the beginning of Technical Training at Joint Base San Antonio-Lackland Air Force in San Antonio, Texas during the 11 ½ week involuntary cessation ban; (2) To randomize participants to either (a) receive our cigarette smoking military tailored pamphlet (HL095758), The Airmen's Guide to Remaining Tobacco Free (Airmen's Guide; which has been disseminated and is now the standard of care in the Air Force) or (b) the Airmen's Guide + Brief Tobacco Intervention (BTI); (3) To determine the short-term (3 month, end of Technical Training) efficacy of the intervention on tobacco abstinence. Our primary outcome is tobacco abstinence at the end of Technical Training to determine an estimated effect size as well as establish the requisite preliminary work for a subsequent R01. Given that over 220,000 new recruits enter the military annually in one of the service branches, the public health implications of an effective brief tobacco intervention targeting the most commonly used tobacco for military personnel in Technical Training is considerable. If the BTI is proven efficacious it can be easily disseminated to other service branches that have similar tobacco bans during Technical Training.

NCT ID: NCT03194958 Completed - Smoking Cessation Clinical Trials

Helping Poor Smokers Quit

Start date: June 5, 2017
Phase: N/A
Study type: Interventional

Using a 2x2 randomized factorial design, we will conduct a statewide field trial in Missouri to compare the relative and combined effects of these two strategies for augmenting an existing, evidence-based tobacco quitline program. Among 2000 low-income smokers, half will receive standard Missouri quitline services and half will receive new Specialized Quitline services targeted to this group. In each of these groups, half also will receive calls from a trained navigator to help them address unmet Basic Needs and the accompanying psychological distress that act as barriers to smoking cessation.

NCT ID: NCT03151421 Completed - Tobacco Use Clinical Trials

Air Quality Feedback to Reduce Second-hand Smoke (SHS) Exposure in the Home

TackSHSWP4
Start date: September 1, 2016
Phase: N/A
Study type: Interventional

This is a European study which is part of a larger research project (The TackSHS project) funded by the European Union's Horizon 2020 Research and Innovation Programme (Grant Agreement No 681040) and led by the Catalan Institute of Oncology. This study will examine the efficacy of using personalised air quality measurements in homes of smokers to encourage behaviour-change towards having a smoke-free home environment. Building on recent quantitative and qualitative work showing that feedback of second-hand smoke (SHS) measurement information can help motivate smokers to change their behaviour. This study will develop a targeted intervention for use with socio-economically deprived smokers in four countries (Scotland, Spain, Greece, Italy) across the EU. Two-hundred smokers (50 in each country) will be recruited and offered low-cost, simple to operate particle counting instruments to measure and log SHS levels in their home for a period of 30 days. During this time near real-time, personalised feedback will be provided to, and discussed with, the smoker along with target-setting and exploration of suitable methods of behaviour-change. Feedback will be given via text message to mobile phones, emails and personal voice calls. A final visit will gather data on changes made while a proportion of participants (10-20%) in each country will take part in a further qualitative interview by phone to gather data on their experience of the intervention. Study outcomes will include quantitative measures such as changes in average and maximum fine particulate matter (PM2.5) concentrations and self-declared household smoking rules, while qualitative data will be gathered using questionnaire and interview to explore what elements of the intervention were useful/unhelpful, particularly well/poorly understood, and what were the barriers for those who did not make changes. This WP will provide a comprehensive database of baseline measurements of SHS concentrations in home settings from across the EU with the potential to generate over 8 million minutes of measurements of household air quality. Analysis of the differences by country and possible determinants of exposure will be carried out.

NCT ID: NCT03111537 Completed - Tobacco Smoking Clinical Trials

Methods Project 4: Clinical Trial - Amended

COMET
Start date: May 2015
Phase: N/A
Study type: Interventional

Cigarette smokers will be randomized to E-cigarette, Nicotine Gum or Lozenge, or Control Group. Participants will enter a 1 week sampling phase. Smokers interested in continuing with the study after the sampling phase will undergo a 2 week baseline assessment phase and will then enter an 8 week intervention. Tobacco use patterns, subjective responses to product, and nicotine and toxicant exposure will be assessed.