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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03235505
Recruitment Status : Completed
First Posted : August 1, 2017
Last Update Posted : February 17, 2023
Sponsor:
Collaborator:
Lapland Central Hospital Rovaniemi Finland
Information provided by (Responsible Party):
Tuula Toljamo, University of Oulu

Tracking Information
First Submitted Date  ICMJE June 2, 2017
First Posted Date  ICMJE August 1, 2017
Last Update Posted Date February 17, 2023
Actual Study Start Date  ICMJE August 1, 2018
Actual Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 15, 2023)
Smoking cessation during the follow-up visit at week 26 [ Time Frame: 24 week ]
7-day point prevalence verified by exhaled-CO<10ppm
Original Primary Outcome Measures  ICMJE
 (submitted: July 28, 2017)
Smoking cessation during the follow-up visit at week 24 [ Time Frame: 24 week ]
7-day point prevalence verified by exhaled-CO<10ppm
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 15, 2023)
  • Smoking cessation at any other study visit [ Time Frame: Baseline,1, 12 and 52 week ]
    7-day point prevalence verified by exhaled-CO < 10pp
  • Reduce smoking at any study visit [ Time Frame: Baseline, 1,4 ,12,16, 26, 36 and 52 week ]
    Prevalence of those who succeeded to decrease the number of daily cigarettes during the study
Original Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2017)
  • Smoking cessation at any other study visit [ Time Frame: Baseline,1, 12 and 52 week ]
    7-day point prevalence verified by exhaled-CO < 10pp
  • Reduce smoking at any study visit [ Time Frame: Baseline, 1,4 ,12,16, 24, 36 and 52 week ]
    Prevalence of those who succeeded to decrease the number of daily cigarettes during the study
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of E-cigarettes for Smoking Cessation in Middle-aged Heavy Smokers
Official Title  ICMJE Efficacy and Safety of E-cigarettes for Smoking Cessation in Middle-aged Heavy Smokers
Brief 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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Smoking Cessation
  • Electronic Cigarette
Intervention  ICMJE
  • Drug: Nicotine
    Nicotine containing e-cigarettes + placebo-varenicline + Motivational Interview (MI)
    Other Name: Innokin Endura T20S
  • Drug: Varenicline Tartrate
    Varenicline + Innokin Endura T20S electronic inhaler but without any nicotine content + MI
    Other Name: Champix
  • Behavioral: Motivational Interview
    Placebo-varenicline + Innokin ENdura T20S electronic inhaler but without any nicotine content +MI
Study Arms  ICMJE
  • Experimental: Nicotine containing e-cigarettes
    Nicotine containing e-cigarettes + placebo-varenicline + Motivational Interview (MI)
    Intervention: Drug: Nicotine
  • Active Comparator: Nicotine-free e-cigarettes
    Nicotine-free e-cigarettes + varenicline tartrate+ MI
    Intervention: Drug: Varenicline Tartrate
  • Placebo Comparator: Motivational Interview (MI)
    Placebo-varenicline + nicotine -free e-cigarettes + MI
    Intervention: Behavioral: Motivational Interview
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 28, 2017)
450
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 31, 2021
Actual Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Aged between 25 to under 75 years
  • Has smoked over 10 years on a daily basis and being a current smoker with at least 10 cig/day for at least past 5 years
  • Good general health
  • Intent to quit smoking
  • Exhaled carbon monoxide level at least 15ppm at the baseline visit
  • Strong nicotine dependence defined by Fagerström Test for Nicotine Dependence (FTND) ≥ 5 and by Heaviness of Smoking Index (HSI) ≥3
  • intent to quit smoking
  • prepared to follow the trial protocol and able to provide written consent.

Exclusion Criteria:

  • Pregnancy or gestation or intend to get pregnant during the study follow-up
  • Use of smoking cessation pharmacotherapy or ECs during the past year
  • Attempt of smoking cessation by using of e-cigarettes during the past year
  • Any cancer (at least five healthy follow-up years after stopping the cancer therapy)
  • Instable (ischemic) vascular or heart disease
  • Recent myocardial infarction in the past three months
  • High blood pressure (systolic BP> 140mmHg or diastolic 90mmHg at rest)
  • History of major psychiatric depression or other psychiatric conditions and daily use of any psychiatric medicine
  • Current addiction of alcohol or misuse of substance
  • Inability to express himself/herself
  • Known allergy to any of the study medications
  • Severe allergy or poorly controlled asthma or other pulmonary disease
  • Epilepsy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03235505
Other Study ID Numbers  ICMJE WI218780
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Tuula Toljamo, University of Oulu
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Oulu
Original Study Sponsor  ICMJE Tuula Toljamo
Collaborators  ICMJE Lapland Central Hospital Rovaniemi Finland
Investigators  ICMJE
Principal Investigator: Tuula Toljamo, PhD Laplnd Central Hospital Rovaniemi Finland
PRS Account University of Oulu
Verification Date February 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP