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Completed

NCT Number: NCT02521662

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

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.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior Smoking Vaping

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

National Institute for Health Innovation, University of Auckland

Auckland, North Island, 1072, New Zealand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nicotine patch

Drug

A transdermal patch that slowly releases nicotine into the body through the skin.

Other names: Nicotine replacement therapy

E-cigarette

Device

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

nicotine

Drug

Nicotine contained in e-liquid (e-juice) used in e-cigarettes

Other names: Nicotine liquid

Behavioural support

Behavioral

Withdrawal-oriented behavioural support

Other names: Smoking cessation behavioural support

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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

  2. 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

  3. 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)

  4. 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.

  5. Time to relapse

    Time frame: One, three, and six months post quit date

    Time to relapse back to daily smoking from quit date

  6. 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).

  7. 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

  8. 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.

  9. Serious adverse events

    Time frame: Participant's set quit date, then one, three, six and 12 months post quit date

  10. 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.

  11. Medication compliance

    Time frame: Participant's set quit date, then one and three months post quit date

    How frequently they used their allocated product

  12. 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.

  13. 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.

  14. 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

  15. 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).

  16. 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)

  17. 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)

Sponsors and collaborators

Lead sponsor

University of Auckland, New Zealand

Other

Collaborators

  • Auckland District Health Board
  • Health New Zealand Ltd, Christchurch, New Zealand

Registry information

Official study title

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

Acronym: ASCEND-II

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 13, 2015
Registry last updated
Aug 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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