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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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Smoking Cessation Electronic Cigarette Drug: Nicotine Drug: Varenicline Tartrate Behavioral: Motivational Interview Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of E-cigarettes for Smoking Cessation in Middle-aged Heavy Smokers
Actual Study Start Date : August 1, 2018
Actual Primary Completion Date : March 31, 2021
Actual Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Nicotine containing e-cigarettes
Nicotine containing e-cigarettes + placebo-varenicline + Motivational Interview (MI)
 Drug: Nicotine
Nicotine containing e-cigarettes + placebo-varenicline + Motivational Interview (MI)
Other Name: Innokin Endura T20S
Active Comparator: Nicotine-free e-cigarettes
Nicotine-free e-cigarettes + varenicline tartrate+ MI
 Drug: Varenicline Tartrate
Varenicline + Innokin Endura T20S electronic inhaler but without any nicotine content + MI
Other Name: Champix
Placebo Comparator: Motivational Interview (MI)
Placebo-varenicline + nicotine -free e-cigarettes + MI
 Behavioral: Motivational Interview
Placebo-varenicline + Innokin ENdura T20S electronic inhaler but without any nicotine content +MI


Outcome Measures
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Primary Outcome Measures :
  1. Smoking cessation during the follow-up visit at week 26 [ Time Frame: 24 week ]
    7-day point prevalence verified by exhaled-CO<10ppm


Secondary Outcome Measures :
  1. Smoking cessation at any other study visit [ Time Frame: Baseline,1, 12 and 52 week ]
    7-day point prevalence verified by exhaled-CO < 10pp

  2. 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03235505


Locations
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Finland
Lapland Central Hospital
Rovaniemi, Finland, 96440
Sponsors and Collaborators
University of Oulu
Lapland Central Hospital Rovaniemi Finland
Investigators
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Principal Investigator: Tuula Toljamo, PhD Laplnd Central Hospital Rovaniemi Finland
More Information
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Responsible Party: Tuula Toljamo, MD, PhD, Chief Chest Physician of Lapland Central Hospital, University of Oulu
ClinicalTrials.gov Identifier: NCT03235505    
Other Study ID Numbers: WI218780
First Posted: August 1, 2017    Key Record Dates
Last Update Posted: February 17, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tuula Toljamo, University of Oulu:
Smoking Cessation
Electronic cigarette
Adults
Additional relevant MeSH terms:
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Nicotine
Varenicline
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action