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Can free nicotine replacement therapy (NRT) increase smoking cessation before scheduled surgery?

Can free nicotine replacement therapy (NRT) increase smoking cessation before scheduled surgery?

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616000073404
Acronym
none
Enrollment
600
Registered
2016-01-22
Start date
2017-01-09
Completion date
2017-12-13
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Tobacco remains a major cause of death in Australia & NZ, with 20,000 annual deaths. Approximately 300,000 smokers have elective surgery each year in Australia & NZ. Smoking increases anaesthetic and surgical risks; particularly respiratory complications and wound infections. Stopping smoking for >4 weeks before surgery significantly reduces these risks, but there is little data on the best ways to help patients quit before surgery. Many smokers make unassisted quit attempts prior to surgery but relapse is common so most arrive in hospital having smoked that day. The use of nicotine patches and engagement with telephone Quitlines significantly increase quitting success in community settings, but have been little studied in surgical populations. Despite strong evidence in their favour, few smokers having surgery use patches and fewer have Quitline contact. There are no studies looking at using these measures at the time patients go onto the surgical wait-list. More research is important because: (1)Stopping before surgery, especially >4-weeks reduces surgical & anaesthetic complications. (2)There is often a significant period of time on the surgical waiting list to allow such quit times to be achieved (3)Surgery is recognised as a teachable moment for behaviour change; a period in one’s life when there is reflection upon health behaviours and increased motivation for positive change. (4) A significant proportion of patients quitting before surgery remain a lifelong non-smoker. Given the large numbers of smokers having surgery each year, efforts to increase abstinence may be a significant public health benefit. This is health services research to evaluate if an offer of a stop-smoking program will increase quitting before surgery. Smokers of 10 or more cigarettes per day (nicotine dependent) will be offered a free 5-week course of free nicotine patches shortly after they go onto the waiting list. The 5-week nicotine patch supply will be mailed to patients in order to make their use as easy and convenient as possible; eliminating many of the barriers to use. Patients who were smokers at time of waiting list placement will be approached on their day of surgery by a data collector and asked for verbal consent for a short interview (<4-minutes). This will ask if they have quit smoking, or made quit attempts before surgery. For those that claim to have quit (>24 hours), we will ask for written permission to confirm this by exhaled carbon monoxide testing plus to make brief telephone contact at 3 and 6 months after surgery to see if they are still quit. A comparison group of patients who smoke will not have this quit package promoted or offered to them.

Interventions

Trial of uptake, acceptability and use of stop-smoking intervention in elective surgical patients who smoke 10+ cigarettes/day. Invitation for a free 5-week supply of nicotine replacement therapy (NRT patches) mailed to participants. Invitation to participate in surgical quit-text program. The 5-week course of NRT will be based on the following regimen: 3-weeks 21mg/24hr patch (Step 1), 1-week 14mg/24hr patch (Step 2) and 1-week 7mg/24hr patch (Step 3). Each patch will be worn for a 24 hour peri

Trial of uptake, acceptability and use of stop-smoking intervention in elective surgical patients who smoke 10+ cigarettes/day. Invitation for a free 5-week supply of nicotine replacement therapy (NRT patches) mailed to participants. Invitation to participate in surgical quit-text program. The 5-week course of NRT will be based on the following regimen: 3-weeks 21mg/24hr patch (Step 1), 1-week 14mg/24hr patch (Step 2) and 1-week 7mg/24hr patch (Step 3). Each patch will be worn for a 24 hour period and replaced by a new patch every 24 hours. The course of patches will be mailed to participants at the time they are placed on the elective surgical wait-list. Monitoring adherence to NRT will be by telephone interview 2 days and 5-weeks after posting the course of patches.

Sponsors

Dr Ashley Webb
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Adults, smoke 10 or more per day, have a phone, on public hospital elective surgery wait-list. Available for data-collection on day of surgery.

Exclusion criteria

1. Unable to understand study requirements 2. Age<18 3. Weight <45 kg (from preop HQ) 4.Pregnancy or breastfeeding 5. Contraindication to nicotine patch. eg allergy 6. Already on stop-smoking medication 7. No phone 8. Emergency surgery 9. Not available for data collection on day of surgery.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026