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27 active trials for Smoking Tobacco

PRogetto Salute Parma

This project from the University Hospital of Parma (AOUPR) aims to verify the feasibility of a prevention program in our district, relying on advanced technological resources and highly experienced team in lung cancer early diagnosis, in order to identify useful elements towards the applicability of such a prevention program on a large scale (regional, national). Uncontrolled, monocentric experimental study with dynamic enrollment and prospective data collection, aimed at implementing a prevention program based on scientific evidence. This study is set to verify the applicability and feasibility of a lung cancer prevention program in a real context, including a preliminary evaluation at the smoking cessation clinic and a LDCT assessment with subsequent LDCT follow-up for participants who show indeterminate findings at the first LDCT (LDCT baseline) exam. The main objective of the study is to verify the feasibility of a lung cancer prevention program according to internationally validated scientific methods. Secondary objectives: To evaluate the use of local smoking cessation clinics and their effects in terms of smoking cessation (primary prevention) To evaluate the outcomes of the program in terms of number of patients with early (presymptomatic) lung cancer treated with minimally invasive surgery (secondary prevention) To evaluate the number of false positives and their diagnostic work-up (PET-CT, CT-guided biopsy, bronchoscopy) Primary endpoint: - Percentage of enrolled subjects to whom the program was offered within 60 days from the date of enrolment and percentage of those who stop smoking for at least 12 months Secondary endpoints: To describe the organizational model, human resources employed, difficulties encountered and elements that have favoured its realization To measure the variation in smoking habits in enrolled smokers To describe the effect of annual LDCT on lung cancer diagnosis rates, considering size, shape, histology and site To measure the consequent demand for further diagnostic investigations and treatment To measure the number of false positives Subjects at high risk of lung cancer screened by the medical team of the AOUPR or by GPs to join the prevention program. Inclusion criteria Age between 50 and 75 years Equivalent tobacco intoxication of ? 15 cigarettes per day for ?25 years or ? 10 cigarettes per day for ?30 years Status of current smoker or ex-smoker for <10 years. Exclusion criteria • Personal history of cancer within the prior 5 years We expect to recruit around 500 people in 1 year. This sample size is considered adequate based on the available resources, both human and economic. After closing and adjusting the database and before data analysis, a document called Statistical Analysis Plan (SAP) will be drawn up. It will consist of the following paragraphs: Statistical methods planned in the study protocol; Size of the sample; Management of missing data; Evaluation of the endpoints; Statistical models that will be applied in the analysis. The socio-demographic characteristics of the enrolled subjects, the adopted organizational methods and the effects of the prevention program (endpoints) will be analyzed and described using tables and figures. The project "PRogetto Salute Parma: Primary and secondary prevention of smoking-related lung cancer" will be started once approved by the institutional Ethics Committee and authorized by the General Manager. The study is expected to be carried out over 2 years (from the inclusion of the first subject), with an expected period of 1 year for the enrolment and 1 further year for follow-up.

Start: February 2020
Opioids and Smoking Cessation

The selection hypothesis of smoking prevalence posits that smokers who are not able to quit successfully are "burdened" by specific characteristics that make it more challenging to quit1. For example, those less successful in quitting smoking may be more nicotine dependent or more likely to suffer from substance use, psychiatric, or medical conditions. In line with this perspective, smoking prevalence has stabilized in the US, presumably because the remaining population has become increasingly representative of those "at-risk smokers" who are unable to quit2. Emerging evidence suggests that persons who suffer from opioid misuse, defined as opioid use without a prescription, at a dose or frequency higher than prescribed, or for a non-medical purpose (e.g., getting high),3 may constitute such a high-risk group. Opioid misuse affects greater than 16% adults who use opioids4 and up to 29% of those with chronic pain.5 The prevalence of tobacco smoking in this group may exceed twice that observed in the general population, and smokers misusing opioids are almost twice as likely to be dependent on nicotine6,7. Yet, the role of opioid misuse in periods of early abstinence and smoking cessation has yet to be explored. The main objective of the present proposal is to fill existing gaps in knowledge by examining the extent to which opioid misuse is associated with decreased success during early smoking abstinence and over the course of an attempt to quit smoking, and to identify mediators and moderators of opioid-smoking relations in this context. This contribution is clinically-significant from a public health standpoint because it will directly guide the development of novel psychosocial/behavioral smoking cessation interventions to help this high-risk population of smokers quit by targeting unique vulnerability processes that result in poor cessation outcomes.

Start: January 2020