The Use of Nicotine Patches Together With E-cigarettes (With and Without Nicotine) for Smoking Cessation (ASCEND-II)

August 17, 2021 updated by: Natalie Walker, University of Auckland, New Zealand

A Randomised-controlled Clinical Trial to Evaluate the Effectiveness and Safety of Combining Nicotine Patches With E-cigarettes (With and Without Nicotine) Plus Behavioural Support, on Smoking Abstinence

A randomised trial to determine whether e-cigarettes (with and without nicotine) combined with nicotine patches and behavioural support can assist smokers in remaining abstinent for at least six months.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A pragmatic, double-blind, three-arm randomised controlled trial undertaken in New Zealand to determine whether e-cigarettes combined with nicotine patches can assist smokers in remaining abstinent for at least six months. 1809 smokers who are motivated to quit will be recruited from the community using media advertising and randomly allocated to one of three groups, namely 1) 21mg nicotine patch daily, 2) 21mg nicotine patch daily plus a 'new generation' e-cigarette with no nicotine or 3) 21mg nicotine patch daily plus a 'new generation' e-cigarettes with nicotine. Participants will be instructed to start using the study products two weeks prior to their quit date, and continue for a further 12 weeks after their quit date. Participants will also receive a cessation behavioural support programme consisting of at least six follow-up telephone calls (10-15 minutes each) over the first six weeks. Outcome data will be collected on the participant's set quit date, then one, three, six and (for some but not all) 12 months post-quit date.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1124

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • New Zealand
    • North Island
      • Auckland, North Island, New Zealand, 1072
        • National Institute for Health Innovation, University of Auckland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Smoke and want to quit in the next three months
  • Reside in New Zealand
  • At least 18 years of age
  • Able to provide verbal consent
  • Have access to telephone (mobile and/or landline)
  • Are prepared to use a nicotine patch or a nicotine patch and e-cigarette together.
  • Only one person per household is eligible.

Exclusion Criteria:

  • Pregnant women
  • Women who are breastfeeding
  • Current users of NRT products
  • People currently enrolled in another smoking cessation programme or other cessation study
  • People who have used an e-cigarette for more than one week in the last year for smoking cessation
  • Current users of non-nicotine based cessation therapies (e.g. buproprion, clonidine, nortriptyline or varenicline).
  • People who have had a heart attack, stroke or severe angina within the previous two weeks.
  • People who self-report a history of severe allergies and/or poorly controlled asthma.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Patch
21mg nicotine patch daily for 14 weeks (including a 2 week prequit period) plus behavioural support for six weeks post-quit
Drug: Nicotine patch
A transdermal patch that slowly releases nicotine into the body through the skin.
Other Names:
  • Nicotine replacement therapy
Behavioral: Behavioural support
Withdrawal-oriented behavioural support
Other Names:
  • Smoking cessation behavioural support
Active Comparator: Patch and nicotine-free e-cigarette
21mg nicotine patch (daily) and nicotine-free e-cigarette (ad libitum) for 14 weeks (including a 2 week prequit period), plus behavioural support for six weeks post-quit
Drug: Nicotine patch
A transdermal patch that slowly releases nicotine into the body through the skin.
Other Names:
  • Nicotine replacement therapy
Behavioral: Behavioural support
Withdrawal-oriented behavioural support
Other Names:
  • Smoking cessation behavioural support
Device: e-cigarette
A electronically powered device that delivers to the user an aerosol of propylene glycol and/or glycerine, with or without flavourings and nicotine.
Other Names:
  • electronic cigarette
  • electronic nicotine delivery device
Active Comparator: Patch and nicotine e-cigarette
21mg nicotine patch (daily) and nicotine e-cigarette (ad libitum) for 14 weeks (including a 2 week prequit period), plus behavioural support for six weeks post-quit
Drug: Nicotine patch
A transdermal patch that slowly releases nicotine into the body through the skin.
Other Names:
  • Nicotine replacement therapy
Behavioral: Behavioural support
Withdrawal-oriented behavioural support
Other Names:
  • Smoking cessation behavioural support
Device: e-cigarette
A electronically powered device that delivers to the user an aerosol of propylene glycol and/or glycerine, with or without flavourings and nicotine.
Other Names:
  • electronic cigarette
  • electronic nicotine delivery device
Drug: Nicotine
Nicotine contained in e-liquid (e-juice) used in e-cigarettes
Other Names:
  • Nicotine liquid

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Continuous abstinence (Russell Standard)
Time Frame: Six months post quit date
Self-report of smoking not more than five cigarettes from the Quit date, supported by biochemical validation (expired air carbon monoxide).
Six months post quit date

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Continuous abstinence
Time Frame: One, three and 12 months post quit date
Self-report of smoking not more than five cigarettes from the Quit date
One, three and 12 months post quit date
7-day point prevalence abstinence
Time Frame: Participant's set quit date, then one, three, six and 12 months post quit date
Self-report of having smoked no cigarettes (not even a puff) in the past seven days, with biochemical verification at six months only
Participant's set quit date, then one, three, six and 12 months post quit date
Number of cigarettes smoked
Time Frame: Participant's set quit date, then one, three, six and 12 months post quit date
Self-report of number of cigarettes smoked per day (or when smoking for non-daily smokers)
Participant's set quit date, then one, three, six and 12 months post quit date
Smoking reduction
Time Frame: Participant's set quit date, then one, three, six and 12 months post quit date
Defined as reducing consumption by at least 25% (in terms of numbers of cigarettes per day or weight of loose tobacco per day or when smoking for non-daily smokers), at all time points.
Participant's set quit date, then one, three, six and 12 months post quit date
Time to relapse
Time Frame: One, three, and six months post quit date
Time to relapse back to daily smoking from quit date
One, three, and six months post quit date
Withdrawal
Time Frame: Participant's set quit date, then at one month post quit date
The physical signs and symptoms associated with withdrawal, measured using the Mood and Physical Symptoms Scale (MPSS).
Participant's set quit date, then at one month post quit date
Self-efficacy
Time Frame: Participant's set quit date
Self-rated chances of quitting, measured on a scale of 1-5 where 1=very low and 5=very high
Participant's set quit date
Use of any other smoking cessation methods/products
Time Frame: Participant's set quit date, then one, three, six and 12 months post quit date
Participants will be asked whether they used any non-NRT methods of cessation since the last assessment (Yes/No), and if yes, when they started using it, the type they used, and frequency of use.
Participant's set quit date, then one, three, six and 12 months post quit date
Serious adverse events
Time Frame: Participant's set quit date, then one, three, six and 12 months post quit date
Participant's set quit date, then one, three, six and 12 months post quit date
Cost
Time Frame: Participant's set quit date, then one, three, six and 12 months post quit date
Cost outcomes will be derived from known costs of the various products include cost per quitter and cost per person reducing their daily cigarette consumption. The tobacco expenditure savings to individual smokers will also be calculated using data on the daily amount smoked prior to quitting and the average price of cigarettes at the time.
Participant's set quit date, then one, three, six and 12 months post quit date
Medication compliance
Time Frame: Participant's set quit date, then one and three months post quit date
How frequently they used their allocated product
Participant's set quit date, then one and three months post quit date
Crossover
Time Frame: Participant's set quit date, then one, three, six and 12 months post quit date
Participants in the patch only arm will be asked whether they accessed and used an e-cigarette (with or without nicotine) during the trial (Yes/No) and at what time during the trial.
Participant's set quit date, then one, three, six and 12 months post quit date
Additional e-cigarette support
Time Frame: Participant's set quit date, then one, three, six and 12 months post quit date
Participants allocated to the e-cigarette groups will be asked whether they accessed any on-line e-cigarette support networks during the trial (Yes/No) and if so what these were (free text), and at what time during the trial.
Participant's set quit date, then one, three, six and 12 months post quit date
Dual use
Time Frame: Participant's set quit date, then one, three, six and 12 months post quit date
Defined as use of both allocated treatment and continued smoking of cigarettes
Participant's set quit date, then one, three, six and 12 months post quit date
Continuation of treatment use
Time Frame: Six and 12 months post quit date
Defined as continued use of allocated treatment after the end of the designated treatment period (12 weeks post-quit).
Six and 12 months post quit date
Perception of their allocated product(s)
Time Frame: Participant's set quit date, then one and three months post quit date
Participants will be asked what they liked and disliked about their allocated products (free text)
Participant's set quit date, then one and three months post quit date
Recommendations
Time Frame: Participant's set quit date, then one and three months post quit date
Participant's will be asked whether they would recommend their allocated treatment to another smoker who wanted to quit (Yes/No)
Participant's set quit date, then one and three months post quit date

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Auckland, New Zealand

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Auckland District Health Board
Health New Zealand Ltd, Christchurch, New Zealand

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Natalie Walker, PhD, National Institute for Health Innovation, School of Population Health, University of Auckland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 9, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 13, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 19, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • U1111-1172-9632

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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