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

NCT03235505 | Completed Phase 4

• 1 other identifier: WI218780
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation; Electronic Cigarette

Keywords

Smoking Cessation; Electronic cigarette; Adults

Outcome Measures

Primary Outcomes (1)

• Smoking cessation during the follow-up visit at week 26

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

  24 week

Secondary Outcomes (2)

• Smoking cessation at any other study visit

  Baseline,1, 12 and 52 week

• Reduce smoking at any study visit

  Baseline, 1,4 ,12,16, 26, 36 and 52 week

Study Arms (3)

Nicotine containing e-cigarettes

EXPERIMENTAL

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

Drug: Nicotine

Nicotine-free e-cigarettes

ACTIVE COMPARATOR

Nicotine-free e-cigarettes + varenicline tartrate+ MI

Drug: Varenicline Tartrate

Motivational Interview (MI)

PLACEBO COMPARATOR

Placebo-varenicline + nicotine -free e-cigarettes + MI

Behavioral: Motivational Interview

Interventions

Nicotine DRUG

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

Also known as: Innokin Endura T20S

Nicotine containing e-cigarettes

Varenicline Tartrate DRUG

Varenicline + Innokin Endura T20S electronic inhaler but without any nicotine content + MI

Also known as: Champix

Nicotine-free e-cigarettes

Motivational Interview BEHAVIORAL

Placebo-varenicline + Innokin ENdura T20S electronic inhaler but without any nicotine content +MI

Motivational Interview (MI)

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oulu: lead
• Lapland Central Hospital Rovaniemi Finland: collaborator

Study Sites (1)

Lapland Central Hospital

Rovaniemi, 96440, Finland

Location

Related Publications (1)

• Tuisku A, Rahkola M, Nieminen P, Toljamo T. Electronic Cigarettes vs Varenicline for Smoking Cessation in Adults: A Randomized Clinical Trial. JAMA Intern Med. 2024 Aug 1;184(8):915-921. doi: 10.1001/jamainternmed.2024.1822.

  PMID: 38884987 DERIVED

MeSH Terms

Conditions

Smoking Cessation; Vaping

Interventions

Nicotine; Varenicline; Motivational Interviewing

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Smoking

Intervention Hierarchy (Ancestors)

Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Quinoxalines; Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Tuula Toljamo, PhD

  Laplnd Central Hospital Rovaniemi Finland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Chief Chest Physician of Lapland Central Hospital

Study Record Dates

• First Submitted: June 2, 2017
• First Posted: August 1, 2017
• Study Start: August 1, 2018
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)