Pharmacotherapy for Tobacco Use Disorder

Authors

Drs. Clara Lu (biography, no disclosures) and Renée Janssen (biography, no disclosures)

What I did before

In the past, I would frame conversations with patients about pharmacotherapy for tobacco use disorder in terms of “smoking cessation” and “helping patients quit.” In line with this approach, I would offer pharmacotherapy only if a patient shared during their clinic visit that they were considering quitting, and I would discuss the risks and benefits of nicotine replacement therapy (NRT), varenicline, and bupropion as first-line options. If the patient was ready to try pharmacotherapy, I would prescribe a 12-week course, leaving follow-up after treatment to the patient’s discretion.

What changed my practice

The 2020 American Thoracic Society (ATS) Clinical Practice Guideline on initiating pharmacologic treatment in tobacco-dependent adults synthesizes recent evidence on the comparative efficacy of different medications and provides several key recommendations on the management of tobacco use disorder.¹ This guideline also calls for a shift in our approach to tobacco use disorder — away from rigid concepts of success versus failure focusing primarily on cessation and abstinence, and toward helping patients increase control over their smoking, regardless of their readiness to quit.

Based on systematic reviews and meta-analyses demonstrating increased rates of abstinence with varenicline compared to both bupropion and the nicotine patch, the ATS guideline strongly recommends varenicline over other pharmacotherapy.¹ A wealth of evidence supporting the safety of varenicline among stable patients has also quelled earlier concerns about serious neuropsychiatric^2–7 and cardiovascular^8–10 adverse effects.

The ATS guideline also presents a meta-analysis of randomized clinical trials demonstrating that offering varenicline to patients who are not yet ready to stop smoking still increases 7-day point prevalence abstinence^11–14, prompting a strong recommendation to offer varenicline to patients without plans for smoking cessation while respecting their autonomy if they decline.¹ The main argument is that access to treatment should not be limited to patients ready to quit smoking, since patients may be willing to try pharmacotherapy even if they have not decided to abstain from smoking. While the guideline panel acknowledged that this recommendation was “unconventional,” providing pharmacotherapy to patients with substance use disorder who are not ready to abstain is not a new concept — as one example, naltrexone is frequently prescribed to reduce cravings among patients with alcohol use disorder who continue to drink.

With this approach, the therapeutic goal expands beyond abstinence toward abstinence readiness. Since “stage of change” is dynamic, providing pharmacotherapy may decrease the compulsion to smoke and therefore increase readiness to quit between clinic visits. Such an approach should not threaten patient autonomy, it merely opens a door toward abstinence without demanding that patients walk through it.

Finally, the 2020 ATS guideline supports the use of varenicline for extended durations (>12 weeks, strong recommendation based on moderate certainty of evidence) and in combination with NRT (conditional recommendation based on low certainty of evidence).¹ However, a subsequent randomized clinical trial of 1251 patients published in 2021 challenged these recommendations after finding no evidence for benefit of either extended or combination regimens compared to standard 12-week varenicline monotherapy.¹⁵

What I do now

Since the publication of the 2020 ATS Clinical Practice Guideline on pharmacologic treatment in tobacco-dependent adults, I now explain the goals of pharmacotherapy for tobacco use disorder in terms of reducing the compulsion to smoke and increasing readiness to quit, rather than abstinence alone. If patients are open to the conversation, I will discuss and offer all pharmacotherapy options — but emphasize the efficacy and safety of varenicline as my preferred first-line agent — regardless of their readiness to quit.

For patients who are not ready to quit but open to trying pharmacotherapy, I will usually offer a written rather than faxed prescription to leave the decision whether and when to fill this medication up to the patient’s discretion. I will schedule a follow-up after 12 weeks to reassess the patient’s status and goals, exploring their preference for continued pharmacotherapy after discussing the potential but unconfirmed effects of treatment durations beyond 12 weeks.

In British Columbia, residents are covered for 12 weeks of pharmacotherapy per calendar year through PharmaCare (varenicline, bupropion, or nicotine replacement monotherapy, but not combined NRT). While varenicline and bupropion require a prescription, NRT does not. If a patient opts for NRT, providers can use the Fagerström Test for Nicotine Dependence to estimate a patient’s level of nicotine dependence and make initial dosing recommendations for NRT.¹⁶ Along with pharmacotherapy, providers can refer their patients to QuitNow BC for a wealth of patient education materials and non-pharmacologic support services.

Resource for patients

QuitNow BC patient education materials: https://quitnow.ca/quitting/preparing-quit. Accessed Feb 28, 2023.

Resources for health-care providers

1. QuitNow BC referral forms: https://quitnow.ca/helping-others-quit/healthcare-providers/referral-program. Accessed Feb 28, 2023.
2. QuitNow training, education, and resources: https://quitnow.ca/helping-others-quit/health-care-providers. Accessed Feb 28, 2023.

References

1. Leone FT, Zhang Y, Evers-Casey S, et al. Initiating Pharmacologic Treatment in Tobacco-Dependent Adults. An Official American Thoracic Society Clinical Practice Guideline. Am J Respir Crit Care Med. 2020;202(2):e5-e31. doi:10.1164/rccm.202005-1982ST (View)
2. Anthenelli RM, Benowitz NL, West R, et al. Neuropsychiatric safety and efficacy of varenicline, bupropion, and nicotine patch in smokers with and without psychiatric disorders (EAGLES): a double-blind, randomised, placebo-controlled clinical trial. Lancet. 2016;387:2507-2520. doi:10.1016/ S0140-6736(16)30272-0 (View with CSPBC or UBC)
3. Thomas KH, Martin RM, Knipe DW, Higgins JP, Gunnell D. Risk of neuropsychiatric adverse events associated with varenicline: systematic review and meta-analysis. BMJ. 2015;350:h1109. Published 2015 Mar 12. doi:10.1136/bmj.h1109 (View)
4. Evins AE, Cather C, Pratt SA, et al. Maintenance treatment with varenicline for smoking cessation in patients with schizophrenia and bipolar disorder: a randomized clinical trial. JAMA. 2014;311(2):145-154. doi:10.1001/jama.2013.285113 (View)
5. Cinciripini PM, Robinson JD, Karam-Hage M, et al. Effects of varenicline and bupropion sustained-release use plus intensive smoking cessation counseling on prolonged abstinence from smoking and on depression, negative affect, and other symptoms of nicotine withdrawal. JAMA Psychiatry. 2013;70(5):522-533. doi:10.1001/jamapsychiatry.2013.678 (View)
6. Anthenelli RM, Morris C, Ramey TS, et al. Effects of varenicline on smoking cessation in adults with stably treated current or past major depression: a randomized trial (published correction appears in Ann Intern Med). 2013 Oct 15;159(8):576]. Ann Intern Med. 2013;159(6):390-400. doi:10.7326/0003-4819-159-6-201309170-00005 (View)
7. Williams JM, Anthenelli RM, Morris CD, et al. A randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of varenicline for smoking cessation in patients with schizophrenia or schizoaffective disorder [published correction appears in J Clin Psychiatry. 2012 Jul;73(7):1035]. J Clin Psychiatry. 2012;73(5):654-660. doi:10.4088/JCP.11m07522 (View with CPSBC or UBC)
8. Windle SB, Dehghani P, Roy N, et al. Smoking abstinence 1 year after acute coronary syndrome: follow-up from a randomized controlled trial of varenicline in patients admitted to hospital. CMAJ. 2018;190(12):E347-E354. doi:10.1503/cmaj.170377 (View)
9. Prochaska JJ, Hilton JF. Risk of cardiovascular serious adverse events associated with varenicline use for tobacco cessation: systematic review and meta-analysis. BMJ. 2012;344:e2856. Published 2012 May 4. doi:10.1136/bmj.e2856 (View)
10. Rigotti NA, Pipe AL, Benowitz NL, Arteaga C, Garza D, Tonstad S. Efficacy and safety of varenicline for smoking cessation in patients with cardiovascular disease: a randomized trial. Circulation. 2010;121(2):221-229. doi:10.1161/CIRCULATIONAHA.109.869008 (View)
11. Ebbert JO, Hughes JR, West RJ, et al. Effect of varenicline on smoking cessation through smoking reduction: a randomized clinical trial. JAMA. 2015;313(7):687-694. doi:10.1001/jama.2015.280 (View)
12. Steinberg ML, Lu SE, Williams JM. Varenicline for smoking reduction in smokers not yet ready to quit: A double-blind, proof-of-concept randomized clinical trial. Addict Behav. 2018;84:20-26. doi:10.1016/j.addbeh.2018.03.026 (View with CPSBC or UBC)
13. Rennard S, Hughes J, Cinciripini PM, et al. A randomized placebo-controlled trial of varenicline for smoking cessation allowing flexible quit dates. Nicotine Tob Res. 2012;14(3):343-350. doi:10.1093/ntr/ntr220 (View)
14. Hughes JR, Rennard SI, Fingar JR, Talbot SK, Callas PW, Fagerstrom KO. Efficacy of varenicline to prompt quit attempts in smokers not currently trying to quit: a randomized placebo-controlled trial. Nicotine Tob Res. 2011;13(10):955-964. doi:10.1093/ntr/ntr103 (View)
15. Baker TB, Piper ME, Smith SS, Bolt DM, Stein JH, Fiore MC. Effects of Combined Varenicline With Nicotine Patch and of Extended Treatment Duration on Smoking Cessation: A Randomized Clinical Trial. JAMA. 2021;326(15):1485-1493. doi:10.1001/jama.2021.15333 (View)
16. Heatherton TF, Kozlowski LT, Frecker RC, Fagerström KO. The Fagerström Test for Nicotine Dependence: a revision of the Fagerström Tolerance Questionnaire. Br J Addict. 1991;86(9):1119-1127. doi:10.1111/j.1360-0443.1991.tb01879.x (View with CPSBC or UBC)

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