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

• ClinicalTrials.gov Identifier: NCT03235505
• Recruitment Status: Active, not recruiting
• First Posted: August 1, 2017
• Last Update Posted: November 25, 2020
• Sponsor: University of Oulu
• Collaborator: Lapland Central Hospital Rovaniemi Finland
• Information provided by (Responsible Party): Tuula Toljamo, University of Oulu

Study Description

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. 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.

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

• 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
• Estimated Primary Completion Date: March 31, 2021
• Estimated Study Completion Date: December 31, 2021

Arms and Interventions

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: Joytech eGo AIO
Active Comparator: Nicotine-free e-cigarettes; Nicotine-free e-cigarettes + varenicline tartrate+ MI	Drug: Varenicline Tartrate; Varenicline + Joytech eGo AIO electronic inhaler but without any nicotine content + MI; Other Name: Chantix
Placebo Comparator: Motivational Interview (MI); Placebo-varenicline + nicotine -free e-cigarettes + MI	Behavioral: Motivational Interview; Placebo-varenicline + Joytech eGo AIO electronic inhaler but without any nicotine content +MI

Outcome Measures

Primary Outcome Measures :

1. Smoking cessation during the follow-up visit at week 24 [ 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, 24, 36 and 52 week ]
   Prevalence of those who succeeded to decrease the number of daily cigarettes during the study

Eligibility Criteria

• Ages Eligible for Study: 30 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Aged between 30 to under 70 years
• Has smoked over10 pack years and is a current smoker at least 10 cig/day for at least past 5 years
• Good general health
• Intent to quit smoking
• Exhaled carbon monoxide (exhaled- CO) 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
• Commits to follow the trial and can provide concent

Exclusion Criteria:

• Non-daily smoker
• Pregnancy or gestation or intend to get pregnant during the study follow-up
• Current use of smoking cessation pharmacotherapy
• Attempt of smoking cessation by using of e-cigarettes during the past year
• Any cancer
• Instable (ischemic) vascular or heart disease
• Recent myocardial infarction (3 months )
• Angina pectoris
• High blood pressure (systolic BP> 140mmHg and /or diastolic 90mmHg at rest)
• Daily use of any psychiatric medicine
• History of major psychiatric depression or other psychiatric conditions
• Current addiction of alcohol or misuse of substance
• Inability to express himself/herself
• Allergy to any of the study medications
• Any severe allergy
• Poorly controlled asthma or other chronic pulmonary disease
• Current use of any smoking cessation therapy

Contacts and Locations

Locations

Finland

Lapland Central Hospital

Rovaniemi, Finland, 96440

Sponsors and Collaborators

University of Oulu

Lapland Central Hospital Rovaniemi Finland

Investigators

• Principal Investigator: Tuula Toljamo, PhD; Laplnd Central Hospital Rovaniemi Finland

More Information

• 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
• Last Update Posted: November 25, 2020
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

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