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

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ClinicalTrials.gov Identifier: NCT02521662
Recruitment Status : Completed
First Posted : August 13, 2015
Last Update Posted : August 19, 2021
Sponsor:
Collaborators:
Health New Zealand Ltd, Christchurch, New Zealand
Auckland District Health Board
Information provided by (Responsible Party):
Natalie Walker, University of Auckland, New Zealand

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Drug: Nicotine patch Device: e-cigarette Drug: Nicotine Behavioral: Behavioural support Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : March 2016
Actual Primary Completion Date : August 2018
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Name: Nicotine replacement therapy

Behavioral: Behavioural support
Withdrawal-oriented behavioural support
Other Name: 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 Name: Nicotine replacement therapy

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

Behavioral: Behavioural support
Withdrawal-oriented behavioural support
Other Name: Smoking cessation behavioural support

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 Name: Nicotine replacement therapy

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 Name: Nicotine liquid

Behavioral: Behavioural support
Withdrawal-oriented behavioural support
Other Name: Smoking cessation behavioural support




Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02521662


Locations
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New Zealand
National Institute for Health Innovation, University of Auckland
Auckland, North Island, New Zealand, 1072
Sponsors and Collaborators
University of Auckland, New Zealand
Health New Zealand Ltd, Christchurch, New Zealand
Auckland District Health Board
Investigators
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Principal Investigator: Natalie Walker, PhD National Institute for Health Innovation, School of Population Health, University of Auckland
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Natalie Walker, Associate Professor of Population Health (Honorary), University of Auckland, New Zealand
ClinicalTrials.gov Identifier: NCT02521662    
Other Study ID Numbers: U1111-1172-9632
First Posted: August 13, 2015    Key Record Dates
Last Update Posted: August 19, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Keywords provided by Natalie Walker, University of Auckland, New Zealand:
Electronic Cigarettes
Nicotine Patch
Smoking Cessation
Additional relevant MeSH terms:
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Nicotine
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