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

Smoking Cessation Clinical Trial

— ASCEND-II  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02521662
• Other study ID #: U1111-1172-9632
• Status: Completed
• Phase: Phase 3
• Start date: March 2016
• Est. completion date: August 2018

Study information

• Verified date: August 2021
• Source: University of Auckland, New Zealand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1124
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Drug:
• Nicotine patch
A transdermal patch that slowly releases nicotine into the body through the skin.

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.

Drug:
• Nicotine
Nicotine contained in e-liquid (e-juice) used in e-cigarettes

Behavioral:
• Behavioural support
Withdrawal-oriented behavioural support

Locations

Country	Name	City	State
New Zealand	National Institute for Health Innovation, University of Auckland	Auckland	North Island

Sponsors (3)

Lead Sponsor	Collaborator
University of Auckland, New Zealand	Auckland District Health Board, Health New Zealand Ltd, Christchurch, New Zealand

Country where clinical trial is conducted

New Zealand, 

References & Publications (2)

Walker N, Parag V, Verbiest M, Laking G, Laugesen M, Bullen C. Nicotine patches used in combination with e-cigarettes (with and without nicotine) for smoking cessation: a pragmatic, randomised trial. Lancet Respir Med. 2020 Jan;8(1):54-64. doi: 10.1016/S2 — View Citation

Walker N, Verbiest M, Kurdziel T, Laking G, Laugesen M, Parag V, Bullen C. Effectiveness and safety of nicotine patches combined with e-cigarettes (with and without nicotine) for smoking cessation: study protocol for a randomised controlled trial. BMJ Open. 2019 Feb 25;9(2):e023659. doi: 10.1136/bmjopen-2018-023659. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Continuous abstinence (Russell Standard)	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	Continuous abstinence	Self-report of smoking not more than five cigarettes from the Quit date	One, three and 12 months post quit date
Secondary	7-day point prevalence abstinence	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
Secondary	Number of cigarettes smoked	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
Secondary	Smoking reduction	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
Secondary	Time to relapse	Time to relapse back to daily smoking from quit date	One, three, and six months post quit date
Secondary	Withdrawal	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
Secondary	Self-efficacy	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
Secondary	Use of any other smoking cessation methods/products	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
Secondary	Serious adverse events		Participant's set quit date, then one, three, six and 12 months post quit date
Secondary	Cost	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
Secondary	Medication compliance	How frequently they used their allocated product	Participant's set quit date, then one and three months post quit date
Secondary	Crossover	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
Secondary	Additional e-cigarette support	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
Secondary	Dual use	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
Secondary	Continuation of treatment use	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
Secondary	Perception of their allocated product(s)	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
Secondary	Recommendations	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