Smoking CessationPhase 4EFFECTNCT03235505
Efficacy and Safety of E-cigarettes for Smoking Cessation in Middle-aged Heavy Smokers
A Phase 4 study testing Nicotine, Varenicline Tartrate and Motivational Interview in people with Smoking Cessation and Electronic Cigarette, run by University of Oulu at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Electronic Cigarette
- What is being tested?
- Nicotine, Varenicline Tartrate and Motivational Interview
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 450 participants
- Where
- 1 siteFinland
- Study dates
- 1 Aug 2018to 31 Mar 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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
- Conditions
- Smoking Cessation, Electronic Cigarette
- Being tested
- Nicotine, Varenicline Tartrate, Motivational Interview
- Keywords
- Smoking Cessation, Electronic cigarette, Adults
- Medical subject headings
- Smoking Cessation, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NicotineDrug
Also called Innokin Endura T20S
Nicotine containing e-cigarettes + placebo-varenicline + Motivational Interview (MI)
Varenicline TartrateDrug
Also called Champix
Varenicline + Innokin Endura T20S electronic inhaler but without any nicotine content + MI
Motivational InterviewBehavioural
Placebo-varenicline + Innokin ENdura T20S electronic inhaler but without any nicotine content +MI
| Study group | Role | What they receive |
|---|---|---|
| Nicotine containing e-cigarettes | Experimental | Nicotine containing e-cigarettes + placebo-varenicline + Motivational Interview (MI) Receives: Drug: Nicotine |
| Nicotine-free e-cigarettes | Active comparator | Nicotine-free e-cigarettes + varenicline tartrate+ MI Receives: Drug: Varenicline Tartrate |
| Motivational Interview (MI) | Placebo comparator | Placebo-varenicline + nicotine -free e-cigarettes + MI Receives: Behavioral: Motivational Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking cessation during the follow-up visit at week 26
7-day point prevalence verified by exhaled-CO<10ppm
Measured: 24 week
Secondary outcomes (2)
Smoking cessation at any other study visit
7-day point prevalence verified by exhaled-CO < 10pp
Measured: Baseline,1, 12 and 52 week
Reduce smoking at any study visit
Prevalence of those who succeeded to decrease the number of daily cigarettes during the study
Measured: Baseline, 1,4 ,12,16, 26, 36 and 52 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2017
- Study start1 Aug 2018
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Collaborators
- Lapland Central Hospital
- Responsible party
- Principal investigator, Tuula Toljamo, University of Oulu
- Investigators
- Tuula Toljamo, PhD, Principal investigator, Laplnd Central Hospital Rovaniemi Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03235505
- Sponsor's protocol ID
- WI218780
- Acronym
- EFFECT
- Status last verified
- May 2024
- First submitted
- 2 Jun 2017
- Last updated
- 16 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38884987
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of E-cigarettes for Smoking Cessation in Middle-aged Heavy Smokers
- ClinicalTrials.gov ID
- NCT03235505
- Acronym / sponsor ID
- EFFECT / WI218780
- Conditions
- Smoking Cessation, Electronic Cigarette
- Keywords
- Smoking Cessation, Electronic cigarette, Adults
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Collaborators
- Lapland Central Hospital
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 1 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nicotine containing e-cigarettes | Experimental | Drug: NicotineNicotine containing e-cigarettes + placebo-varenicline + Motivational Interview (MI) |
| Nicotine-free e-cigarettes | Active comparator | Drug: Varenicline TartrateNicotine-free e-cigarettes + varenicline tartrate+ MI |
| Motivational Interview (MI) | Placebo comparator | Behavioral: Motivational InterviewPlacebo-varenicline + nicotine -free e-cigarettes + MI |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NicotineAlso: Innokin Endura T20SNicotine containing e-cigarettes + placebo-varenicline + Motivational Interview (MI) | Drug | Nicotine containing e-cigarettes |
| Varenicline TartrateAlso: ChampixVarenicline + Innokin Endura T20S electronic inhaler but without any nicotine content + MI | Drug | Nicotine-free e-cigarettes |
| Motivational InterviewPlacebo-varenicline + Innokin ENdura T20S electronic inhaler but without any nicotine content +MI | Behavioural | Motivational Interview (MI) |
Primary outcome
Smoking cessation during the follow-up visit at week 26
Time frame: 24 week
7-day point prevalence verified by exhaled-CO<10ppm
2 secondary outcomes
Smoking cessation at any other study visit
Time frame: Baseline,1, 12 and 52 week
Reduce smoking at any study visit
Time frame: Baseline, 1,4 ,12,16, 26, 36 and 52 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Derived from this study: PubMed 38884987Tuisku 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tuula Toljamo, PhD principal investigator
Laplnd Central Hospital Rovaniemi Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nicotine, Varenicline Tartrate and Motivational Interview in people with Smoking Cessation and Electronic Cigarette, run by University of Oulu at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking cessation during the follow-up visit at week 26 (time frame: 24 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03235505, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.