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Clinical guidelines

Supporting smoking cessationA guide for health professionals

Nicotine replacement therapy

Key points

  • Smoking cessation using NRT to quit is always safer than continuing to smoke.
  • All forms of NRT (at equivalent doses) are similarly effective in aiding long-term cessation.
  • All forms of NRT monotherapy can increase the rate of quitting by 50–70%.
  • Higher dose forms of NRT (4 mg) are more effective than lower dose forms (2 mg) for more addicted smokers.
  • More than one form of NRT can be used concurrently with increased success rates and no safety risks.
  • Nicotine patches can be given several weeks prior to smoking cessation to help smokers prepare for quitting.
  • NRT can be used by people with cardiovascular disease. Caution is advised for people in hospital for acute cardiovascular events, but if the alternative is active smoking, NRT can be used under medical supervision.
  • NRT can be used by smokers aged 12–17 years.
  • NRT may be appropriate in pregnant smokers if they have been unsuccessful in stopping smoking without NRT.
  • Intermittent, short-acting dosage forms (oral) are preferred in pregnancy to long-acting dosage forms (patches).

Nicotine is the main substance in tobacco that causes addiction – it makes people dependent on cigarettes – but it is the other chemicals in combusted tobacco that cause cancer, accelerate heart disease and affect other areas of health. The aim of NRT is to reduce craving and withdrawal symptoms by providing some of the nicotine that would normally be obtained from cigarettes, without providing the harmful components of tobacco smoke. NRT is available over the counter in pharmacies, and some forms are available in supermarkets in Australia. Nicotine patches are subsidised on the PBS. None of the available forms of NRT (transdermal patch, gum, inhalator, lozenge, mouth spray and oral strip) offer the same rapid nicotine delivery of a cigarette.

Some oral forms of NRT are available in two strengths: 2 mg and 4 mg (gum and lozenge) and 1.5 mg and 4 mg (mini lozenge) (Table 5, page 33). The 4 mg version is recommended for more-dependent smokers (those who smoke within 30 minutes of waking) and should also be considered for lighter smokers who continue to report cravings when using the weaker form.98,104

 Table 5. Nicotine replacement therapy initial dosing guidelines

Patient group

Dose

Duration
(weeks)

Contraindications

(*adapted from MIMS online May 2014)

Patch

>10 cigarettes per day
and weight >45 kg

21 mg/24 hr or 25 mg/16 hr

 

>8

(Unscheduled) non-smokers; children under 12 years; hypersensitivity to nicotine or any component of the patch; diseases of the skin that may complicate patch therapy

<10 cigarettes per day or
weight <45 kg or
cardiovascular disease

14 mg/24 hr or 10 mg/16 hr

>8

Gum

First cigarette >30 minutes after waking

2 mg 8–12
per day

>8

(Unscheduled) non-tobacco users; known hypersensitivity to nicotine or any component of the gum; children (<12 years)

First cigarette <30 minutes after waking

4 mg 6–10
per day

>8

Inhaler

>10 cigarettes per day

6–12 cartridges
per day

>8

(S2) Non-tobacco users; hypersensitivity to nicotine or menthol; children (<12 years)

Inhalator

Assessed as tobacco dependent

3–6 cartridges per day

>8

(S2) Non-tobacco users; hypersensitivity to menthol; children (<12 years)

Lozenge

First cigarette
>30 minutes after waking

1.5 mg or 2 mg
1 lozenge every 1–2 hr

>8

(Unscheduled) non-smokers; hypersensitivity to nicotine or any component of the lozenge; children (<12 years); phenylketonuria

First cigarette
<30 minutes after waking

4 mg 1 lozenge every 1–2 hr

>8

Nicotine oral spray
Nicotine oral strips

Assessed as tobacco-dependent

Up to 4 sprays per hour

>8

(Unscheduled) non-tobacco users; children (<12 years)

(Unscheduled) non-tobacco users; children (<18 years)

First cigarette
>30 minutes after waking

2.5 mg 1 oral strip every 1–2 hr, use at least 9 strips per day

>8

Source: *Adapted from Smoking cessation guidelines for Australian general practice. Canberra, 2004

It is important to advise smokers on the correct use of the different forms of NRT and to ensure that an adequate dose is taken to relieve cravings and withdrawal symptoms. Patients should be reassured about the safety, efficacy and low addictiveness of NRT, as misinformed concerns in smokers are a major cause of poor compliance.105,106

Regular use of NRT beyond 12 months is not generally recommended. However, long-term use of some forms of NRT have been reported and has not caused ill health effects – it may help some people remain abstinent107 and it is much safer than smoking.

Combination NRT

Combining two forms of NRT (patch plus oral form, such as gum or lozenge) has been shown to be more efficacious than a single form of nicotine replacement. The patch provides a steady background nicotine level and the oral forms provide relief for breakthrough cravings as needed. There is evidence from nine trials that this type of combination NRT is more effective than a single type.108 Health professionals should encourage smokers to use combined NRT if they are unable to quit using one NRT product alone, or experience cravings using only one form of NRT. Combination NRT can also be recommended as first line treatment.99,109 In Australia, the combination of NRT patch and 2 mg gum, 2 mg lozenge or 1.5 mg mini lozenge is licensed for smokers who have relapsed in the past or who experience cravings using only one form of NRT.110 Some experts now recommend combination therapy for all dependent smokers using NRT, rather than monotherapy, including use of the stronger forms of oral products for those who need them.

Pre-cessation nicotine patch

There is evidence to support use of the nicotine patch prior to smoking cessation. A meta-analysis found that the nicotine patch used prior to quit day increased success rates compared to standard therapy.111 The Therapeutic Goods Administration (TGA)-approved approach involves using either a 21 mg/24 hour patch or a 25 mg/16 hour patch for 2 weeks before quitting, then continuing to use nicotine patch in the usual way for the quit attempt and adding oral NRT if needed.

Reduce to quit

There is also evidence for use of NRT to help smokers who are not willing to quit immediately to reduce their tobacco and then progress to quitting.112 The TGA-approved approach (cut down then stop or reduce to quit) involves smokers using NRT to reduce the number of cigarettes they smoke before stopping completely within 6 months. A meta-analysis found that reducing cigarettes smoked before quit day versus quitting abruptly, with no prior reduction, produced comparable quit rates.113 Health professionals should offer smokers the choice to quit in either of these ways. Further research is needed to investigate those categories of smokers who benefit the most from each method.

Safety

Using therapeutic nicotine is always safer than continuing to smoke. All forms of NRT can be used by patients with stable cardiovascular disease, but should be used with caution in people with recent myocardial infarction, unstable angina, severe arrhythmias and recent cerebrovascular events. However, there is growing evidence for the safety of NRT in smokers with acute coronary syndromes and NRT can be used in this situation under medical supervision.114

NRT can be used by smokers who are pregnant, but alternative non-drug cessation strategies should be used first There is inconclusive evidence of the effectiveness and safety of NRT during pregnancy and other forms of pharmacotherapy are contraindicated. If NRT is used, the benefits and risks should be discussed with the patient. Although nicotine is presumed to have some risk, clinical trials of therapeutic nicotine have not generally reported adverse fetal effects.115 Available data and expert opinion suggest that it is less harmful than continued smoking.116 Given the importance of smoking cessation in pregnancy for the health of both the mother and fetus, it has been suggested that NRT should be offered to the nicotine-dependent smoker if the initial attempt is not successful within a week.117

Intermittent (oral) NRT is generally recommended as this delivers a lower total nicotine dose, however the clearance rate of nicotine is increased during pregnancy and it is important to use adequate doses to relieve cravings and withdrawal symptoms.118

Nicotine passes from the mother to child through breast milk, depending on the concentration of nicotine in the maternal blood, but the nicotine in breast milk is unlikely to be dangerous.116 Women who smoke should be encouraged to continue breastfeeding and provided with strategies to minimise the potential harm to their child associated with the secondhand smoke.

Side effects

Minor side effects are common with NRT use.110 Common adverse effects with NRT depend on the delivery system. For the patch, they include skin erythema, skin irritation and sleep disturbance (abnormal dreams). For gum, lozenge and sublingual tablet, minor side effects include dyspepsia and nausea, and for the inhalator and mouth spray, mouth and throat irritation may occur.54

Availability of nicotine patches on the PBS

Health professionals should check for updated PBS listings at www.pbs.gov.au. Nicotine patches (25 mg/16 hours, 15 mg/16 hours and 21 mg/24 hours) are listed on the PBS for use as an aid to quitting for people who participate in a support and counselling program. A maximum of one PBS-subsidised 12-week course of nicotine patches (one original 4-week script plus two repeats) is subsidised per year. A streamlined authority prescription is required which includes the expectation that a support program is provided. The brands of patch listed on the PBS at the time of publication consist of either:

  • 1 x 12-week supply of the Nicorette 25 mg/16-hour patch, or
  • 1 x 12-week supply of the Nicabate 21 mg/24-hour patch, or
  • 1 x 12-week supply consisting of 4 weeks of the Nicotinell 21 mg/24-hour patch + 4 weeks of the 14 mg/24-hour patch + 4 weeks of the 7 mg/24-hour patch.

The subsidised patches are not available at the same time as other PBS subsidised smoking cessation therapies (varenicline and bupropion), but if a person is unsuccessful quitting using the nicotine patches, then they are able to access PBS-subsidised medicines during that same 12-month period.

Aboriginal and Torres Strait Islander people

People who identify as Aboriginal or Torres Strait Islander qualify for PBS authority listing that provides up to two courses per year of nicotine patches, each of a maximum of 12 weeks. Under this listing, participation in a support and counselling program is recommended but not mandatory. Access to nicotine patches for Aboriginal and Torres Strait Islander people can be facilitated through the Closing the Gap PBS co-payment measure (see page 45).

Evidence

Nicotine replacement used as monotherapy increases quit rates by 50–70% at a minimum of 6 months, follow-up compared with placebo, and regardless of the setting. Level I
There is no evidence of increased risk for use of NRT in people with stable cardiovascular disease. Level II
There is no evidence of an association between use of nicotine patch and acute cardiac events. Level II
There is currently a lack of evidence on the safety of NRT in pregnancy but international guidelines recommend use of NRT in certain circumstances. Level V
Combinations of different forms of NRT (eg. patch plus gum) are more effective than one form alone. Level I

Recommendations

NRT should be recommended to nicotine-dependent smokers. There is no significant difference in effectiveness of different forms of NRT in achieving cessation so choice of product depends on clinical and personal considerations. Strength A
NRT is safe to use in patients with stable cardiovascular disease. Strength A
NRT should be used with caution in patients who have had a recent myocardial infarction, unstable angina, severe arrhythmias or recent cerebrovascular events. Strength C
Use of NRT should be considered when a pregnant woman is otherwise unable to quit. Intermittent NRT is preferred to patches (lower total daily nicotine dose). Strength C
Combination NRT should be offered to more-dependent smokers and those who are unable to remain abstinent or continue to experience withdrawal symptoms using one type of therapy. Strength A

References

  1. Richmond RL, Zwar NA. Treatment of tobacco dependence. In: Boyle P, Gray N, Henningfield J, Seffrin J, Zatonski W, editors. Tobacco: science, policy and public health. 2nd edn. Oxford UK: Oxford University Press; 2010.
  2. Stead LF, Perera R, Bullen C, Mant D, Lancaster T. Nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev 2008, Issue 1. Art. no. CD000146.
  3. Aubin H-J, Bobak A, Britton JR, et al. Varenicline versus transdermal nicotine patch for smoking cessation results from a randomised open-label trial. Thorax 2008;63:717–24.
  4. Shiffman S, Sembower MA, Rohay JM, Gitchell JG,  Garvey AJ. Assigning dose of nicotine gum by time to first cigarette. Nicotine Tob Res 2013;15:407–12.
  5. Mendelsohn C. Optimising nicotine replacement therapy in clinical practice. Aust Fam Phys 2013;42(5): 305−9.
  6. Ferguson S. Use of smoking cessation aids. Role of perceived safety and efficacy. JOSC 2012.
  7. Anthonisen NR, Skeans MA, Wise RA, et al; Lung Health Study Research Group. The effects of a smoking cessation intervention on 14.5-year mortality: a randomized clinical trial. Ann Intern Med 2005;142:233–9.
  8. Stead LF, Perera R, Bullen C, Mant D, Hartmann-Boyce J, Cahill K, et al. Nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev 2012;11:CD000146
  9. Fiore MC, Bailey WC, Cohen SJ, et al. Treating tobacco use and dependence: clinical practice guideline. Rockville, MD: United States Department of Health and Human Services, 2000.
  10. National Prescribing Service. Nicotine patches (Nicabate P, Nicorette, Nicotinell Step 1). NPS Radar April 2011. Available at http://www.nps.org.au/publications/health-professional/nps-radar/2011/february-2011/nicotine-patches [accessed 5 April 2011].
  11. Shiffman S, Ferguson SG. Nicotine patch therapy prior to quitting smoking: a meta- analysis. Addiction 2008;103:557–63.
  12. Action on Smoking and Health Australia. Nicotine replacement therapy: guidelines for healthcare professionals on using nicotine replacement therapy for smokers not yet ready to stop smoking. Woolloomooloo (Australia): ASH, February 2007. Available at www.ashaust.org.au/pdfs/NRTguide0702.pdf [accessed 29 April 2011].
  13. Lindson N, Aveyard P, Hughes JR. Reduction versus abrupt cessation in smokers who want to quit. Cochrane Database Syst Rev 2010, Issue 3. Art. no. CD008033.
  14. Mendelsohn CP. Smoking and cardiovascular disease. Cardiology Today 2013;3(4):23−25.
  15. Coleman T, Chamberlain C, Davey MA, Cooper SE, Leonardi-Bee J. Pharmacological interventions for promoting smoking cessation during pregnancy. Cochrane Database Syst Rev 2012;9:CD010078.31
  16. Dempsey DA, Benowitz NL. Risks and benefits of nicotine to aid smoking cessation in pregnancy. Drug Saf 2001;24(4):277−322.
  17. Gould GA. A pragmatic guide for smoking cessation counselling and the initiation of nicotine replacement therapy for pregnant ATSI smokers. JOSC 2014.
  18. Mendelsohn C, Gould GS, Oncken C. Management of smoking in pregnant women. Aust Fam Physician. 2014:43(102): 46−51.
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