SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT03235505

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

Efficacy and Safety of E-cigarettes for Smoking Cessation in Middle-aged Heavy Smokers

Abstract Rationale. Electronic cigarette use is increasing at an exponential rate in Finland and internationally. The health consequences of vaporised aerosols in electronic cigarettes are largely unknown especially in a long run. Still, very few studies are available on quitting attempts with e-cigarettes as a smoking cessation tool compared to evidence based cessation pharmacotherapy in adult smokers who want to quit. Research Objective: To investigate effectiveness and safety of e-cigarettes for smoking cessation in middle-aged smokers, and to compare the effectiveness of them to varenicline. Our study provides new information of success in smoking cessation among heavy adult smokers for clinicians. Design: A double-blind, randomised, placebo-controlled clinical trial with the intervention phase of 12 weeks and the observational phase up to 52 weeks. This is an investigator initiated study. Setting: Volunteer middle-aged daily smokers, who were recruited through newspaper announcements. The majority of the cohort subjects (n=513)were recruited for our previous follow-ip study during years 2003- 2009, and many of them continued daily smoking during the whole follow-up period. Participants: In all, 450 adult heavy smokers, who want to quit smoking and are willing to participate up to 52 weeks┬┤ follow-up. Intervention and procedures: Standardized self-reported questionnaires with detailed smoking history with assessment of motivation to quit smoking, parameters of nicotine dependence, symptoms will be included. Smoking status will be repeatedly reassessed during the study visits, and self-reported smoking abstinence is verified with exhaled-carbon monoxide (CO) assessment. All adverse side effects either of drugs or of e-cigarettes, and symptoms related to the drugs or to withdrawal from smoking will be carefully reported.

NCT03235505 Smoking Cessation Electronic Cigarette

3 Interventions

Name: Nicotine

Description: Nicotine containing e-cigarettes + placebo-varenicline + Motivational Interview (MI)

Type: Drug

Nicotine containing e-cigarettes

Name: Varenicline Tartrate

Description: Varenicline + Joytech eGo AIO electronic inhaler but without any nicotine content + MI

Type: Drug

Nicotine-free e-cigarettes

Name: Motivational Interview

Description: Placebo-varenicline + Joytech eGo AIO electronic inhaler but without any nicotine content +MI

Type: Behavioral

Motivational Interview (MI)


Primary Outcomes

Description: 7-day point prevalence verified by exhaled-CO<10ppm

Measure: Smoking cessation during the follow-up visit at week 24

Time: 24 week

Secondary Outcomes

Description: 7-day point prevalence verified by exhaled-CO < 10pp

Measure: Smoking cessation at any other study visit

Time: Baseline,1, 12 and 52 week

Description: Prevalence of those who succeeded to decrease the number of daily cigarettes during the study

Measure: Reduce smoking at any study visit

Time: Baseline, 1,4 ,12,16, 24, 36 and 52 week

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 T20S

Each arm has 12 weeks intervention and observation up to 12 months: A.Nicotine containing e-cigarettes + placebo-pills + Motivational Interview (MI) Innokin Endura T20S + USB cable with wall adapter via USB cable (output DC5V)+ + 6x 10ml /month refill containing 18mg/ml nicotine with cigarette taste for 12 weeks. --- T20S ---

Participants are allowed to use ad libitum e-cigarettes during 12 weeks after they have chosen the quit day during the 2nd follow-up week Placebo -pills: starting week: 0,5mg once daily on days 1.-3 and 0,5mg twice daily on days 4.-5.Continuing weeks: 1mg twice daily up to 12 weeks B.Nicotine-free e-cigarettes + varenicline + MI Innokin Endura T20S + USB cable with wall adapter via USB cable (output DC5V)+ + 6x 10ml /month refill containing 0mg/ml nicotine with cigarette taste for 12 weeks Participants are allowed to use ad libitum e-cigarettes during 12 weeks after they have chosen the quit day during the 2nd follow-up week Varenicline (Chantix®) Starting week: 0,5mg once daily on days 1.-3 and 0,5mg twice daily on days 4.-5. --- T20S ---

Continuing weeks: 1mg twice daily up to 12 weeks C.Placebo-varenicline + nicotine -free e-cigarettes + MI Placebo -pills : starting week: 0,5mg once daily on days 1.-3 and 0,5mg twice daily on days 4.-5.Continuing weeks: 1mg twice daily up to 12 weeks Innokin Endura T20S + USB cable with wall adapter via USB cable (output DC5V)+ 6x 10ml /month refill containing 0mg/ml nicotine with cigarette taste for 12 weeks Participants are allowed to use ad libitum e-cigarettes during 12 weeks after they have chosen the quit day during the 2nd follow-up week --- T20S ---



HPO Nodes