Efficacy and Safety of E-cigarettes for Smoking Cessation in Middle-aged Heavy Smokers
Condition: Smoking Cessation; Electronic Cigarette
Study type: Interventional
Phase: Phase 4

Summary: 
      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. Some of the cohort subjects were re-recruited from our previous follow-up
      study as many of them continued daily smoking during the whole follow-up period.

      Participants: Targeted sample size of 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.
    

Detailed description: 
      This is a study with three arms. 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.

      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. 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
    

Intervention name(s): Nicotine; Varenicline Tartrate; Motivational Interview
Intervention type(s): Drug; Drug; Behavioral
Intervention description(s): Nicotine containing e-cigarettes + placebo-varenicline + Motivational Interview (MI); Varenicline + Innokin Endura T20S electronic inhaler but without any nicotine content + MI; Placebo-varenicline + Innokin ENdura T20S electronic inhaler but without any nicotine content +MI
Other intervention name(s): Innokin Endura T20S; Champix
Intervention MeSH terms: Nicotine; Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Smoking Cessation; Electronic cigarette; Adults