in progress

Draft Recommendation Statement

Tobacco Smoking Cessation in Adults, Including Pregnant Persons: Interventions

June 02, 2020

Recommendations made by the USPSTF are independent of the U.S. government. They should not be construed as an official position of the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services.

This topic is being updated. Please use the link(s) below to see the latest documents available.
  • Update in Progress for Tobacco Smoking Cessation in Adults, Including Pregnant Persons: Interventions

Recommendation Summary

Population Recommendation Grade
Nonpregnant adults The USPSTF recommends that clinicians ask all adults about tobacco use, advise them to stop using tobacco, and provide behavioral interventions and U.S. Food and Drug Administration (FDA)--approved pharmacotherapy for cessation to adults who use tobacco. A
Pregnant persons The USPSTF recommends that clinicians ask all pregnant persons about tobacco use, advise them to stop using tobacco, and provide behavioral interventions for cessation to pregnant persons who use tobacco. A
Pregnant persons The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of pharmacotherapy interventions for tobacco cessation in pregnant persons. I
Adults, including pregnant persons The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of electronic cigarettes (e-cigarettes) for tobacco cessation in adults, including pregnant persons. The USPSTF recommends that clinicians direct patients who use tobacco to other tobacco cessation interventions with proven effectiveness and established safety. I

Additional Information

Tools
Related Resources
  • Interventions for Tobacco Smoking Cessation in Adults (Consumer Guide): Draft Recommendation | Link to File

Full Recommendation:

Recommendations made by the USPSTF are independent of the U.S. government. They should not be construed as an official position of the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services.

Expand All

Tobacco use is the leading preventable cause of disease, disability, and death in the United States. Annually, more than 480,000 deaths are attributed to cigarette smoking, including secondhand smoking.1 Smoking during pregnancy can increase the risk for miscarriage, congenital anomalies, stillbirth, fetal growth restriction, preterm birth, placental abruption, and complications in the offspring, including sudden infant death syndrome and impaired lung function in childhood.1-4 In 2018 (the most recent data currently available), an estimated 49.1 million U.S. adults (19.7% of the adult population) used tobacco; 34.2 million U.S. adults (13.7% of the adult population) currently smoked cigarettes5 and 8.1 million (3.2% of the adult population) used e-cigarettes.5 Seven percent of women who give birth in the United States smoke during pregnancy.6

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The USPSTF concludes with high certainty that the net benefit of behavioral interventions and FDA-approved pharmacotherapy for tobacco smoking cessation, alone or combined, in nonpregnant adults who smoke is substantial.

The USPSTF concludes with high certainty that the net benefit of behavioral interventions for tobacco smoking cessation on perinatal outcomes and smoking cessation in pregnant persons is substantial.

The USPSTF concludes that the evidence on pharmacotherapy interventions for tobacco smoking cessation in pregnant persons is insufficient because few studies are available, and the balance of benefits and harms cannot be determined.

The USPSTF concludes that the evidence on the use of e-cigarettes for tobacco smoking cessation in adults, including pregnant persons, is insufficient, and the balance of benefits and harms cannot be determined. The USPSTF has identified the lack of well-designed, randomized, controlled trials (RCTs) on e-cigarettes that report smoking abstinence or adverse events as a critical gap in the evidence.

See Table 1 for more information on the USPSTF recommendation rationale and assessment. For more details on the methods the USPSTF uses to determine net benefit, see the USPSTF Procedure Manual.7

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Patient Population Under Consideration

This recommendation applies to adults age 18 years or older, including pregnant persons. The USPSTF has issued a separate recommendation statement on primary care interventions for the prevention and cessation of tobacco use in children and adolescents.8

Definitions

“Tobacco use” refers to use of any tobacco product. As defined by the FDA, tobacco products include any product made or derived from tobacco intended for human consumption (except products that meet the definition of drugs), including, but not limited to, cigarettes, cigars (including cigarillos and little cigars), dissolvables, hookah tobacco, nicotine gels, pipe tobacco, roll-your-own tobacco, smokeless tobacco products (including dip, snuff, snus, and chewing tobacco), vapes, e-cigarettes, hookah pens, and other electronic nicotine delivery systems (ENDS).9 “Smoking” generally refers to the inhaling and exhaling of smoke produced by combustible tobacco products such as cigarettes, cigars, and pipes. “Vaping” refers to the inhaling and exhaling of aerosols produced by e-cigarettes.10 Vape products usually contain nicotine, which is the addictive ingredient in tobacco. Substances other than tobacco can also be used to smoke or vape. While the 2015 USPSTF recommendation statement used the term “electronic nicotine delivery systems” or “ENDS,” the USPSTF recognizes that the field has shifted to using the term “e-cigarettes” (or “e-cigs”) and uses the term e-cigarettes in the current recommendation statement. E-cigarettes can come in many shapes and sizes, but generally they heat a liquid that contains nicotine (the addictive drug in tobacco) to produce an aerosol (or “vapor”) that is inhaled (“vaped”) by users.10 Although tobacco use refers broadly to the use of any tobacco product, cigarette smoking has historically been the most prevalent form of tobacco use in the United States and most of the evidence surrounding cessation of tobacco products relates to quitting combustible cigarette smoking. Thus, the current USPSTF recommendations focus on interventions for tobacco smoking cessation. Additionally, although e-cigarettes are considered a tobacco product that should also be the focus of tobacco prevention and cessation efforts, for this recommendation statement, the evidence on e-cigarettes as a potential cessation aid for cigarette smoking was also evaluated.

Assessment of Tobacco Use

All patients should be asked about their tobacco use, whether or not risk factors for use are present, and encouraged to stop using tobacco. When smoking is identified, all patients should be provided interventions to quit smoking. Increased smoking prevalence has been observed in men; persons younger than age 65 years; American Indian/Alaska Native persons; multiracial persons; persons who are lesbian/gay or bisexual; persons with a GED (vs. graduate-level education); persons with an annual household income of less than $35,000; and persons with mental health conditions.5

Common approaches for clinicians to assess patients’ tobacco use include the following.

  • The 5 A’s: 1) Ask about tobacco use; 2) Advise to quit through clear, personalized messages; 3) Assess willingness to quit; 4) Assist in quitting; and 5) Arrange followup and support.11
  • “Ask, Advise, Refer,” which encourages clinicians to ask patients about tobacco use, advise them to quit, and refer them to telephone quit lines, other evidence-based cessation interventions, or both.11
  • Vital Sign: Treating smoking status as a vital sign and recording smoking status at every health visit are also frequently used to assess smoking status.11

Because many pregnant women who smoke do not report it, using multiple choice questions to assess smoking status in this group may improve disclosure.11

Interventions for Tobacco Cessation and Implementation Considerations

Nonpregnant Adults

Effective tobacco smoking cessation interventions for nonpregnant adults include behavioral counseling and pharmacotherapy, either individually or in combination.12

Behavioral counseling interventions. Many behavioral interventions are available to encourage tobacco smoking cessation in adults. These interventions can be delivered in the primary care setting or can be referred to community settings with feedback to the primary care provider. Effective behavioral interventions include physician advice, nurse advice, individual counseling with a cessation specialist, group behavioral interventions, telephone counseling, and mobile phone–based interventions.12 Behavioral counseling interventions used in studies typically targeted individuals who were motivated to quit tobacco smoking.12 For additional information about behavioral counseling interventions in nonpregnant adults, see Table 2.

Pharmacotherapy. The current pharmacotherapy interventions approved by the FDA for the treatment of tobacco smoking dependence in adults are nicotine replacement therapy or NRT (including nicotine transdermal patches, lozenges, gum, inhalers, or nasal spray), bupropion hydrochloride sustained-release (SR), and varenicline.13 All three types of pharmacotherapy increase tobacco smoking cessation rates. Using a combination of NRT products (in particular, combining short-acting plus long-acting forms of NRT) has been found to be more effective than using just a single form of NRT.12 Based on a smaller number of studies, varenicline appears to be more effective than NRT or bupropion SR.12 Information on dosing regimens is available in the package inserts of individual medications or in the “2020 Surgeon General Report on Smoking Cessation.”14

Combined behavioral counseling interventions with pharmacotherapy. Combining behavioral and pharmacotherapy interventions may increase tobacco smoking cessation rates compared with minimal behavioral interventions (such as self-help materials or brief advice on quitting) or pharmacotherapy alone.12 Combination interventions often involve several sessions (≥4) with planned total contact time usually ranging from 90 to 300 minutes.12 The largest effect was found in interventions that provided eight or more sessions, although the difference in effect among the number of sessions was not significant.12

Pregnant Persons 

Behavioral counseling interventions. Providing any psychosocial intervention to pregnant persons who smoke tobacco can increase smoking cessation. The behavioral counseling intervention type most often studied in pregnant persons who smoke was counseling. Behavioral interventions were more effective when they provided more intensive counseling, were augmented with messages and self-help materials tailored for pregnant women, and included messages about the effects of smoking on both maternal and fetal health and strong advice to quit as soon as possible.11,12 Although smoking cessation at any point during pregnancy yields substantial health benefits for the expectant mother and baby, quitting early in pregnancy provides the greatest benefit to the fetus.11,12 Other interventions included feedback, incentives, health education, and social support, although provision of health education alone, without counseling, was not found to be effective. For additional information about behavioral counseling interventions in pregnant persons, see Table 2.

Additional Resources

Primary care clinicians may find the following resources useful in talking with adults and pregnant persons about tobacco smoking cessation. 

In addition, the following resources may be useful to primary care clinicians and practices trying to implement interventions for tobacco smoking cessation. 

Suggestions for Practice Regarding the I Statements

Pharmacotherapy for Pregnant Persons

Approximately 7% of women who give birth report smoking cigarettes during pregnancy6 and 3.6% of pregnant women ages 18 to 44 years report using e-cigarettes.15 Smoking during pregnancy reduces fetal growth, increases the risk of preterm birth, and doubles the risk for delivering a baby with low birth weight. It also increases the risk for stillbirth death by 25% to 50%.1,2 Quitting smoking early in pregnancy can reduce or eliminate the adverse effects of smoking on fetal growth.14 For pregnant persons for whom behavioral counseling does not work, evidence to support other options to promote smoking cessation during pregnancy are limited. Few clinical trials have evaluated the effectiveness of NRT for smoking cessation in pregnant women. Although most studies were in the direction of benefit, no statistically significant improvement in cessation was seen.12 There is limited evidence on harms of NRT from trials in pregnant persons. It has been suggested that NRT may be safer than smoking during pregnancy given that cigarette smoke contains other harmful substances that NRT does not.16 Potential adverse maternal events reported in studies include slightly increased diastolic blood pressure and skin reactions to the patch.12 Potential adverse events reported in nonpregnant adults include higher rates of low-risk cardiovascular events, such as tachycardia.12 The USPSTF identified no studies on bupropion SR or varenicline pharmacotherapy for tobacco smoking cessation during pregnancy.

In the absence of clear evidence on the balance of benefits and harms of pharmacotherapy in pregnant women, clinicians are encouraged to consider the severity of tobacco smoking behavior in each patient and engage in shared decision making to determine the best individual treatment course.

E-Cigarettes in Nonpregnant Adults and Pregnant Persons

Tobacco smoking cessation can be extremely difficult for many individuals; thus, having a variety of tools available to help persons quit smoking would potentially be helpful. Findings from small surveys and qualitative data report mixed findings on whether physicians are recommending e-cigarette to patients to help them quit smoking.12,17-19 Few randomized trials have evaluated the effectiveness of e-cigarettes to increase tobacco smoking cessation in nonpregnant adults, and no trials have evaluated e-cigarettes for tobacco smoking cessation in pregnant persons.12 Overall, results were inconsistent on whether smoking cessation improved with e-cigarettes; however, continued e-cigarette use after the intervention phase of trials remained high. Trial evidence on harms of e-cigarettes used for smoking cessation is also limited. The most commonly reported side effects from e-cigarette use reported in trials include coughing, nausea, throat irritation, and sleep disruption.12 Generally, no significant difference in short-term serious adverse events associated with e-cigarette use was reported.12 Evidence on potential harms of e-cigarette use in general (whether for tobacco smoking cessation or not) has been reviewed in the National Academy of Science, Engineering, and Medicine report on the “Public Health Consequences of E-Cigarettes.”20 Additionally, an outbreak of e-cigarette and vaping product associated lung injury (EVALI) that occurred in the United States in late 2019 also suggests potential harms of e-cigarette use, although most cases have been associated with tetrahydrocannabinol (THC)-containing e-cigarettes.21

Given the high rates of e-cigarette use in children and adolescents currently in the United States,22 the USPSTF recognizes that an overall public health question remains on whether the potential use of e-cigarettes as a tobacco smoking cessation aid (if ever proven effective) could be balanced with the potential use of e-cigarettes in youth as a driver for increasing overall tobacco use. The USPSTF has issued a separate recommendation statement on the prevention of tobacco use, including e-cigarettes, in children and adolescents.8 The current USPSTF recommendation statement for adults evaluated the evidence on the benefits and harms of e-cigarettes to increase tobacco cessation; the USPSTF found this evidence to be insufficient. Given the proven effectiveness of behavioral counseling interventions in both nonpregnant and pregnant adults, and pharmacotherapy in nonpregnant adults, the USPSTF recommends clinicians offer behavioral counseling and pharmacotherapy for smoking cessation in nonpregnant adults, and behavioral counseling for smoking cessation in pregnant persons.

Other Related USPSTF Recommendations

In 2020, the USPSTF recommended that primary care clinicians provide interventions, including education or brief counseling, to prevent the initiation of tobacco use (including e-cigarettes) in school-aged children and adolescents.8 The USPSTF found the evidence on primary care interventions for the cessation of tobacco use in youth to be insufficient.

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Scope of Review

The USPSTF commissioned a systematic review to evaluate the benefits and harms of primary care interventions on tobacco use cessation in adults, including pregnant persons. The USPSTF considered evidence on the benefits and harms of behavioral counseling interventions in nonpregnant adults and pregnant persons and pharmacotherapy interventions in nonpregnant adults. The vast majority of evidence identified focused on tobacco smoking cessation. 

Benefits of Tobacco Cessation Interventions

Nonpregnant Adults 

Behavioral counseling interventions. The USPSTF reviewed evidence on the benefits of behavioral counseling interventions on tobacco use cessation in general adults primarily from 20 systematic reviews that covered approximately 830 RCTs and more than 500,000 participants.12 The evidence almost exclusively evaluated interventions for cessation of cigarette smoking. Physician advice, nurse advice, individual counseling with a cessation specialist, group behavioral interventions, telephone counseling, and mobile phone–based interventions have all been found to be effective to improve cessation of cigarette smoking.12

Based on a 2013 systematic review, which pooled analyses of 26 studies (n=22,239), rates of smoking cessation at 6 months or more were 8.0% in groups that received physician advice compared with 4.8% in groups that received no advice or usual care (risk ratio [RR], 1.76 [95% CI, 1.58 to 1.96]).12,24 When stratified by intensity level, both minimal advice (defined as a single session lasting <20 minutes with ≤1 followup sessions) and intensive advice (defined as a single session lasting ≥20 minutes or >1 followup session) from a physician significantly increased cessation rates compared with no advice. Although not definitive, some subgroup analyses suggest that more intensive physician counseling (>20 minutes on initial consult, use of additional materials, or having >1 followup visit) may increase cessation rates, particularly in patients who have smoking-related disease.12,24

Based on pooled analyses of 44 studies from a 2017 systematic review that evaluated nurse advice, 14.2% of participants who received interventions from nurses achieved smoking cessation at 6 months or more compared with 12.2% of those who received usual care or minimal intervention (RR, 1.29 [95% CI, 1.21 to 1.38]).12,25 No evidence of effect modification was found when comparing higher- or lower-intensity counseling provided by nurses.

A systematic review from 2017, which pooled analyses of 33 studies (n=13,762), found that 11.4% of participants who received individual counseling with a cessation specialist achieved smoking cessation, compared with 7.7% of those who received minimal contact of less than 15 minutes of advice (RR, 1.48 [95% CI, 1.34 to 1.64]).12,26 The review found some evidence suggesting that more intensive counseling increased cessation rates. Another systematic review published in 2017, which pooled analyses of 13 studies (n=4,395), also found that participants receiving group behavioral interventions had greater cessation rates compared with those who received a self-help program (10.4% cessation rate in intervention group vs. 5.8% cessation rate in control group; RR, 1.88 [95% CI, 1.52 to 2.33]).12,27

A 2019 review on telephone counseling interventions found that proactive telephone counseling (where telephone counselors called participants directly either to initiate counseling or in response to a participant calling a quitline) improved cessation rates.12,28 If the telephone counseling was a “cold call” from telephone counselors to initiate counseling, smoking cessation rates increased from 11.0% in controls to 13.9% in telephone counseling recipients (RR, 1.25 [95% CI, 1.15 to 1.35]; k=65; n=41,233).12,28 If telephone counseling occurred in response to a participant contacting a quitline, cessation rates increased from 7.8% in controls to 10.8% in intervention recipients (RR, 1.38 [95% CI, 1.19 to 1.61]; k=14; n=32,484).12,28

A 2019 review that pooled analyses of 13 studies (n=14,133) found an improvement in cessation rates with mobile phone–based interventions.12,29 All studies primarily used text messaging as the main intervention component, although a limited number of studies looked at individual mobile phone applications. Smoking cessation rates improved from 5.6% in participants receiving usual or minimal care to 9.5% in those receiving mobile phone–based interventions (RR, 1.54 [95% CI, 1.19 to 2.00]). The USPSTF also considered evidence on other behavioral counseling interventions such as print-based self-help materials, internet-based interventions, motivational interviewing, biofeedback, exercise, acupuncture, and hypnotherapy.12 The USPSTF either did not find sufficient evidence on these interventions or results did not show statistically significant effects. 

Pharmacotherapy. The USPSTF reviewed evidence from four systematic reviews on pharmacotherapy smoking cessation at 6 months or more in nonpregnant adults.12

A 2018 review on NRT (133 studies; n=64,640)30 found that 16.9% of participants taking any form of NRT achieved smoking abstinence at 6 months or more compared with 10.5% of participants receiving placebo or taking no NRT (RR, 1.55 [95% CI, 1.49 to 1.61]). All forms of NRT (patch, gum, inhaler, intranasal, and tablets) were found to be effective. Another review found that using combination NRT (patch plus a fast-acting form) achieved higher smoking cessation rates than using just one form of NRT (16.9% vs 13.9%).31

A 2014 systematic review on the use of antidepressants for smoking cessation (44 studies; n=13,728) found that bupropion SR was associated with a significantly higher rate of smoking abstinence at 6 months or more than placebo or no bupropion SR (19.7% vs. 11.5%; RR, 1.62 [95% CI, 1.49 to 1.76]).32

Based on pooled analyses of 27 studies (n=12,625), a 2016 systematic review found that varenicline increased smoking cessation over placebo (25.6% vs 11.1%; RR, 2.24 [95% CI, 2.06 to 2.43]).33

Smaller subsets of studies from these reviews directly compared types of pharmacotherapy for smoking cessation. Eight studies (n=6,264) compared varenicline and NRT and found that varenicline was associated with a greater smoking cessation rate over any form of NRT.33 Five studies (n=5,877) evaluated varenicline vs. bupropion SR and found that varenicline was associated with a higher cessation rate.33 Smoking cessation rates among participants using NRT vs. bupropion SR at 6 months or more did not significantly differ (8 studies; n=4,086).32

Combinations of behavioral counseling interventions and pharmacotherapy. Combinations of behavioral counseling and pharmacotherapy for smoking cessation were also effective.12 A 2016 systematic review (52 studies; n=19,488)34 found that participants who received combination pharmacotherapy and intensive behavioral counseling had a higher abstinence rate at 6 months or more compared with control participants who received usual care, self-help materials, or brief advice on quitting (which was less intensive than the counseling or support given to the intervention groups) (15.2% vs. 8.6%; RR, 1.83 [95% CI, 1.68 to 1.98]). These combination interventions often have behavioral components delivered by specialized smoking cessation counselors or trained staff; however, no difference in effectiveness was seen in studies where a nonspecialist provided the counseling.12 Most studies used NRT as the pharmacotherapy. The intensity and format of the behavioral counseling component of the intervention varied greatly, with the majority of studies offering at least four behavioral counseling sessions, with a total planned contact time generally ranging from 90 to 300 minutes. Most of the behavioral counseling was delivered by a specialized smoking cessation counselor or trained trial staff. Another systematic review,35 which pooled analyses of 65 studies (n=23,331), found that cessation rates at 6 months or more were modestly higher in participants who received behavioral support as an adjunct to pharmacotherapy than in those who received pharmacotherapy alone (19.5% vs. 17.1%; RR, 1.15 [95% CI, 1.08 to 1.22]). Most studies offered NRT as the pharmacotherapy. Participants in the control group may have also received some counseling or support, but it was less intensive than in the intervention group. The addition of behavioral support to pharmacotherapy also significantly increased cessation rates from approximately 17% in persons using pharmacotherapy alone to 20% in those using a combination of pharmacotherapy and behavioral support.12

Pregnant Persons

For benefits of tobacco use cessation interventions in pregnant persons, the USPTF reviewed evidence from an existing systematic review on behavioral counseling interventions and from primary studies of pharmacotherapy. As with the evidence base in nonpregnant adults, the available evidence primarily addressed tobacco smoking cessation. 

Behavioral counseling interventions. Based on a systematic review from 2017,36 the USPSTF found that behavioral counseling interventions in pregnant women are effective at improving rates of tobacco smoking cessation as well as some perinatal health outcomes. Pooled analyses from 97 studies (n=26,637) found that use of any psychosocial intervention improved smoking cessation rates in late pregnancy, from 12.2% in control groups to 16.4% in intervention groups (RR, 1.35 [95% CI, 1.23 to 1.48]). The majority of studies used counseling interventions, and analyses of only counseling interventions (51 studies; n=18,276) found a significant increase in smoking cessation rates late in pregnancy, from 10.8% in control groups to 14.5% in intervention groups (RR, 1.31 [95% CI, 1.16 to 1.47]). Studies of other intervention types (health education, feedback, incentives, social support, and exercise) were much fewer with fewer total participants. Findings of smoking cessation effectiveness by intervention type were all in the direction of benefit, although not all were statistically significant. No subgroup differences by intervention type was found. The same systematic review also assessed the effect of behavioral counseling interventions on perinatal outcomes and found improved mean birth weight (mean difference, 55.6 g [95% CI, 29.82 to 81.38]; k=26; n=11,338) and rates of low birth weight (RR, 0.83 [95% CI, 0.72 to 0.94]; k=18; n=9,402). No statistically significant difference in rates of preterm births or stillbirths was found.

Pharmacotherapy. The USPSTF identified four placebo-controlled trials on NRT during pregnancy.12 All four trials included behavioral counseling or support in addition to NRT. One trial used NRT gum as the intervention, while the other three trials used a NRT patch. Adherence to NRT in studies was low (<10% in one study). Findings of the four trials were all in the direction of benefit with NRT; however, none of the studies, either individually or when pooled, found a statistically significant difference in smoking cessation (11.9% in NRT intervention groups vs. 10.1% in control groups; RR, 1.17 [95% CI, 0.78 to 1.76]; k=4; n=1,896).12 Six trials (the four placebo-controlled trials previously mentioned plus two additional nonplacebo-controlled trials) reported on perinatal and health outcomes with NRT during pregnancy;12 findings were inconsistent and imprecise. No studies on bupropion SR or varenicline for smoking cessation during pregnancy were identified.

E-Cigarettes in Nonpregnant Adults and Pregnant Persons

Approximately 3.2% of adults5,37 and 3.6% of pregnant women15 report using e-cigarettes. Higher e-cigarette use is reported among young adults ages 18 to 24 years (7.6%)38 and has been increasing in recent years.38 In addition to young adults, e-cigarette use among adults is higher in men; multiracial persons; American Indian/Alaska Native persons; lesbian/gay or bisexual5 persons; and persons with chronic illnesses (such as cardiovascular disease, diabetes, cancer, asthma, chronic obstructive pulmonary disease, chronic kidney disease, and depression).12,39 Most e-cigarette users report that quitting smoking and health improvement are major reasons why they started using e-cigarettes.40,41 In 2015, among adults who smoked, 68% wanted to stop smoking and 55% attempted quitting in the past year;42 only 7% reported having recently quit smoking and 31% reported having used cessation counseling, medication, or both when trying to quit.42 Nineteen percent of tobacco users use two or more tobacco products, the most common combination being cigarettes and e-cigarettes.43

The USPSTF identified four RCTs (n=2,967) on e-cigarettes for smoking cessation in nonpregnant adults12,44-48 and no studies in pregnant persons.12 All four studies were conducted outside of the United States (two in New Zealand, one in Italy, and one in the United Kingdom). Three of the studies included participants who either wanted to stop smoking or were attending a stop smoking service. The type of e-cigarette interventions (nicotine content, whether NRT was also given, nicotine cartridge vs. e-liquid, and whether behavioral support was also provided) and control interventions (NRT vs. nonnicotine e-cigarette) varied across studies, making comparisons difficult. Only two of the e-cigarettes used in the studies are currently available in the United States. Study size ranged from 300 to 1,124 participants.

Reported trial findings were inconsistent. The two largest and most recent trials reported a statistically significant increase in smoking cessation at 6 months; one study reported smoking cessation rates of 4% in control groups vs. 7%48 in interventions groups; the second trial reported smoking cessation rates of 25% in control groups vs. 35%47 in intervention groups. The two remaining trials either reported no statistically different smoking cessation rate or differences of borderline statistical significance. Three of the studies reported on continued e-cigarette use after achievement of smoking cessation in intervention groups at 6 months to 1 year; continued e-cigarette use ranged from 38% to 80%. One study reported that 26.9% of all study participants were using e-cigarettes at 1 year.46

Harms of Tobacco Cessation Interventions

Nonpregnant Adults 

Behavioral counseling interventions. The USPSTF identified limited evidence on harms from behavioral counseling interventions for tobacco cessation. Three systematic reviews (one on internet-based interventions, another on incentives, and one on hypnotherapy) did not find evidence of serious adverse events associated with interventions.12

Pharmacotherapy. The USPSTF identified four systematic reviews on NRT that reported on harms;12 three reviews compared harms of NRT vs. placebo30,49,50 and one review compared harms from various types of NRT.31 Twelve to 21 studies (n=10,234 to 11,647) reported on cardiovascular harms. Statistically significant increases in cardiovascular adverse events (in particular, heart palpitations and chest pain) were found (RR, 1.81 [95% CI, 1.35 to 2.43]; k=21; n=11,647).50 However, when analyses focused on major cardiovascular adverse events (combined outcome of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke), findings were no longer statistically significant (RR, 1.38 [95% CI, 0.58 to 3.26]; k=21; n=11,647).50 Other reported harms associated with NRT include nausea, vomiting, gastrointestinal complaints, and insomnia. Localized increased skin irritation at the NRT patch site has also been reported. No statistically significant increase in headaches, dizziness, anxiety, or depression were found. Cardiac adverse events and serious adverse events did not differ by type of NRT.31

The USPSTF considered evidence on harms from bupropion SR for tobacco smoking cessation from four systematic reviews.12 No difference in serious adverse events (RR, 1.30 [95% CI, 1.00 to 1.69]; k=33; n=9,631),32 cardiovascular adverse events (RR, 1.03 [95% CI, 0.71 to 1.50]; k=27; n=10,402),50 or major cardiovascular events (RR, 0.57 [95% CI, 0.31 to 1.04]; k=27; n=10,402)50 were found with bupropion SR (compared with placebo or no bupropion SR). No difference in moderate and severe neuropsychiatric events, including rates of suicidal behavior and ideation, were found with bupropion SR (compared with varenicline or NRT) in the recent Evaluating Adverse Events in a Global Smoking Cessation Study (EAGLES) trial.51,52

Harms of varenicline for tobacco cessation are available from three systematic reviews on varenicline in unselected smokers, four systematic reviews of varenicline among persons with severe mental illness, and one review on varenicline for cessation of smokeless tobacco.12 Common side effects reported with varenicline include nausea, insomnia, abnormal dreams, headache, and fatigue.12 One review found an increase in serious adverse events with varenicline in unselected smokers (RR, 1.25 [95% CI, 1.04 to 1.49]; k=29; n=15,370).33 Across three systematic reviews (encompassing 18 to 38 studies; n=8,587 to 12,706), no statistically significant difference in cardiovascular adverse events or cardiovascular severe adverse events was found.12 No statistically significant increase in neuropsychiatric adverse events (including depression, suicidal ideation, and suicide attempt) was found across several systematic reviews.12

Combinations of behavioral counseling interventions and pharmacotherapy. The USPSTF did not identify any reports of adverse events related to combinations of behavioral counseling interventions and pharmacotherapy.

Pregnant Persons

 Behavioral counseling interventions. The primary review that informed the USPSTF on the benefits of behavioral counseling interventions for smoking cessation during pregnancy also summarized evidence on harms of behavioral counseling interventions.36 Based on analyses of 13 trials (n=5,831), no increase in adverse effects from psychosocial interventions was seen.

Pharmacotherapy. Nicotine in general has been shown in animal studies to cause fetal harms. However, NRT does not contain some harmful substances, such as hydrogen cyanide and carbon monoxide, that are present in cigarettes.16 Evidence on harms of NRT during pregnancy is limited; the USPSTF identified four placebo-controlled trials (n=1,898), two nonplacebo controlled trials (n=233), and three cohort studies (n=306,721).12 Findings on potential harms of NRT from trial evidence on birth outcomes is mixed, although most studies reported findings in the direction of benefit rather than harm. Observational evidence from cohort studies generally did not indicate an increase in stillbirth or low birth weight with NRT. No evidence on harms of bupropion SR or varenicline for tobacco cessation during pregnancy was identified. According to FDA labeling, some fetal harms with bupropion were noted in animal studies but currently, no adequate, well-controlled studies of bupropion SR use during pregnancy (for any indication) in humans are available.53 Labeling for varenicline states that available studies cannot definitively establish or exclude varenicline-associated risk during pregnancy.54

E-Cigarettes in Nonpregnant Adults and Pregnant Persons

The USPSTF identified eight RCTs (n=3,792) that reported on harms of e-cigarette interventions for tobacco smoking cessation in nonpregnant adults12 (the four trials previously described that reported cessation rates at 6 months or more, as well as an additional four trials that reported on cessation rates at less than 6 months). No trials on harms of e-cigarettes for smoking cessation in pregnant persons was identified. The most commonly reported side effects from e-cigarette use reported in trials include coughing, nausea, throat irritation, and sleep disruption.12 Generally, no significant difference in short-term serious adverse events associated with e-cigarette use was reported.12 Data on potential long-term harms of e-cigarette use is currently lacking.

Additional evidence on harms from e-cigarette use (whether used for tobacco cessation or not) considered by the USPSTF included data of the 2019 EVALI outbreak in the United States21 and the 2018 report on the “Public Health Consequences of E-Cigarettes” by the National Academy of Science, Engineering, and Medicine.20 In late 2019, an outbreak of EVALI occurred in the United States when cases of severe lung illness in younger adults who otherwise seemed healthy were noted. Symptoms of EVALI include cough, shortness of breast or chest pain, as well as nausea, vomiting, stomach pain, diarrhea, fever, chills, or weight loss. As of February 2020, more than 2,800 cases of EVALI were reported, with 68 deaths.21 Based on bronchoalveolar lavage fluid samples of patients with EVALI55 and EVALI patient–reported product use,21 vitamin E acetate, an additive to some THC-containing e-cigarettes (especially when obtained from informal sources) was found to be strongly linked to EVALI.21 However, contributions from other chemicals found in e-cigarettes could not definitively be ruled out.21

The National Academy of Science, Engineering, and Medicine report found that in youth and young adults, there is substantial evidence that e-cigarette use increases risk of ever using combustible tobacco and moderate evidence that e-cigarette use increases the frequency and intensity of subsequent cigarette smoking.20 The report also found conclusive evidence that e-cigarettes contain and emit potentially toxic substances, although substantial evidence shows that other than nicotine, there is significantly lower exposure to potentially toxic substances from e-cigarettes compared with combustible tobacco cigarettes.20

How Does Evidence Fit With Biological Understanding?

Because of the well-established health benefits of smoking cessation,1,11,14 most of the research on interventions for smoking cessation focuses on cessation (rather than health outcomes) as a primary outcome. The current review identified one study56 of middle-aged men at high risk for cardiorespiratory disease that found lower (although not statistically significant) total mortality, fatal coronary disease, and lung cancer death at 20 years of followup in participants who received advice from medical practitioners.57 The study also found favorable effects on all-cause mortality, coronary disease mortality, and lung cancer incidence and mortality at 20 years of followup, although these effects were not significant.57

Based on finding that less toxins are released from e-cigarettes (although not zero) than those released by cigarettes, it is hypothesized that health outcomes may be improved in adults who completely switch from combustible tobacco smoking to e-cigarette use, although long-term data are not available yet to support this. Evidence on long-term harms of e-cigarette use in general is lacking. Additionally, it is unclear whether any health benefits could be expected for individuals who continue to smoke cigarettes and use e-cigarettes.

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The greatest research needs are to gain a better understanding of the effectiveness of e-cigarettes for smoking cessation, as well as potential short-term and long-term harms of e-cigarette use, and to understand whether there are effective pharmacotherapy options for pregnant persons.

  • E-cigarettes: Given the potential negative effect that increasing e-cigarette use in youth is having on overall tobacco control efforts, there is a strong need for research that provides both a clearer understanding of whether e-cigarettes may improve adult tobacco smoking cessation, as well as the potential harms of e-cigarette use. Future research on e-cigarettes for smoking cessation in adults should address the following:
    • Studies must be well-designed RCTs that compare e-cigarette interventions with placebo as well as established, effective combinations of pharmacotherapy and behavioral support.
    • Studies should be adequately powered to detect differences in continued smoking abstinence rates at 6 months or more.
    • Given the high rate of continued e-cigarette use after smoking cessation, research on both the short-term and the long-term harms of e-cigarette use is needed, as well as the harms in dual users of e-cigarettes and conventional cigarettes. More research is needed on smoking relapse rates in adults who have used e-cigarettes for smoking cessation and how to completely transition e-cigarette users off of e-cigarettes.
    • Given the rapidly evolving landscape of e-cigarettes, trials should include current generations of e-cigarettes. Additionally, to successfully conduct these types of studies, standardization of how to quantify e-cigarette use and levels of nicotine exposure from e-cigarettes is needed.
    • More research is needed to understand the patterns of e-cigarette use in youth and the risk factors for their transition from e-cigarette use to conventional cigarette smoking.
    • More research is also needed to better understand patterns of e-cigarette use in pregnant persons and potential harms of e-cigarette use to both pregnant persons and their offspring.
    • Lastly, more research is needed on understanding how to help adults quit e-cigarettes.
  • Pharmacotherapy in Pregnant Persons: Although behavioral counseling interventions have been found to be effective in improving smoking cessation during pregnancy, additional research on pharmacotherapy options, in particular NRT, for pregnant persons for whom behavioral counseling interventions are not effective is needed.
    • Larger studies that are adequately powered to detect an effect on both smoking cessation rates (during pregnancy and postpartum) and changes in perinatal and child health outcomes are needed.
    • A better understanding of why adherence rates to NRT during pregnancy is so low would also be helpful.

Although the benefits of behavioral counseling interventions and pharmacotherapy in nonpregnant adults and the benefits of behavioral counseling interventions in pregnant adults are well established, additional research on effective components of behavioral counseling and who to target specific interventions to would be informative. More research on newer modalities and remotely delivered interventions (mobile phone apps, internet-based interventions) would also be helpful. Additionally, the effectiveness of interventions for cessation of other forms of tobacco and whether interventions need to be tailored to individual tobacco product types are also needed.

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Numerous professional societies and health organizations, including the American Academy of Family Physicians,58 American College of Physicians,59 and American College of Obstetricians and Gynecologists,60 recommend that clinicians screen for tobacco use and provide interventions to patients who smoke.

More recently some organizations have addressed e-cigarette use in their tobacco use guidelines. The American Academy of Family Physicians,61 the American College of Preventive Medicine,62 and the American Heart Association63 recommend that clinicians screen for e-cigarette use. Organizations vary in terms of whether they recommend e-cigarettes for smoking cessation. The American College of Obstetricians and Gynecologists recommends against use of e-cigarettes in pregnant and postpartum individuals.60,64 The American Cancer Society does not recommend e-cigarettes as a smoking cessation method,65 and the American Heart Association63 states that there is not enough evidence for clinicians to counsel patients on using e-cigarettes as a primary smoking cessation aid.

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Rationale Nonpregnant Adults Pregnant Persons
Benefits of Intervention
  • Convincing evidence that the benefit of behavioral interventions (including physician and nurse advice, individual and group counseling, and telephone and mobile phone–based interventions), alone or combined with pharmacotherapy, to improve achievement of tobacco smoking cessation in nonpregnant adults who smoke is substantial.
  • Convincing evidence that the benefit of pharmacotherapy interventions, including nicotine replacement therapy (NRT), bupropion hydrochloride sustained-release (bupropion SR), and varenicline—with or without behavioral counseling interventions—to achieve tobacco smoking cessation in nonpregnant adults is substantial.
  • Convincing evidence that using two types of NRT (fast-acting plus patch) moderately improves tobacco smoking cessation rates over using one type, and that addition of NRT to treatment with bupropion SR provides additional benefit over use ofbupropion SR alone.
  • Inadequate evidence to determine the effect of electronic cigarettes (e-cigarettes) on achievement of tobacco smoking cessation
  • Convincing evidence that the benefit of behavioral interventions to achieve tobacco smoking cessation in pregnant persons, and prevent infant low birth weight, is substantial.
  • Inadequate evidence on pharmacotherapy because of few available studies on the benefits of NRT and no studies reporting on the benefits of bupropion SR, varenicline, or e-cigarettes to achieve tobacco smoking cessation in pregnant persons or to improve infant outcomes.
Harms of Intervention
  • Adequate evidence to bound the magnitude of harms of behavioral interventions for tobacco smoking cessation in nonpregnant adults as small to none, based on the nature of the interventions, the low likelihood of serious harms, and the available information from studies reporting few harms. When direct evidence is limited, absent, or restricted to select populations or clinical scenarios, the USPSTF may place conceptual upper or lower bounds on the magnitude of benefit or harms.
  • Adequate evidence that the harms of pharmacotherapy interventions for tobacco smoking cessation in adults with NRT, bupropion SR, or varenicline are small.
  • Harms of NRT include irritation at nicotine exposure site, chest pain, arrhythmia, and minor cardiovascular events such as palpitations and bradycardia.
  • A nonstatistically significant increase in severe adverse events was found with bupropion SR but no difference in study withdrawals due to adverse events was seen and no increased risk of cardiovascular events (any or major) was seen with bupropion SR.
  • Use of varenicline was not associated with cardiovascular or neuropsychiatric adverse events but may be associated with an increased risk of general severe adverse events.
  • Inadequate evidence to determine the harms of e-cigarettes as a tobacco smoking cessation tool.
  • Adequate evidence to bound the magnitude of harms of behavioral interventions for tobacco smoking cessation in pregnant persons who smoke as small to none based on the nature of the intervention, the low likelihood of serious harms, and the available information from studies reporting few harms. When direct evidence is limited, absent, or restricted to select populations or clinical scenarios, the USPSTF may place conceptual upper or lower bounds on the magnitude of benefit or harms.
  • Inadequate evidence on the harms of pharmacotherapy interventions because of few available studies on NRT and no studies reporting on the harms of bupropion SR, varenicline, or e-cigarettes for tobacco smoking cessation in pregnant persons who smoke.
USPSTF Assessment
  • High certainty that the net benefit of behavioral interventions and U.S. Food and Drug Administration–approved pharmacotherapy interventions for tobacco smoking cessation, alone or combined, in nonpregnant adults who smoke is substantial.
  • Insufficient evidence on the use of e-cigarettes for tobacco smoking cessation in adults, and the balance of benefits and harms cannot be determined. There is a critical gap in the evidence due to a lack of well-designed, randomized, controlled trials on e-cigarettes for cessation that report smoking abstinence or adverse events.
  • High certainty that the net benefit of behavioral interventions for tobacco smoking cessation on perinatal outcomes and smoking cessation in pregnant persons is substantial.
  • Insufficient evidence on pharmacotherapy interventions for tobacco smoking cessation in pregnant persons because of a lack of studies, and the balance of benefits andharms cannot be determined.
  • Insufficient evidence on the use of e-cigarettes for tobacco smoking cessation in pregnant persons, and the balance of benefits and harms cannot be determined. Evidence is lacking.
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Intervention Physician or Nurse Advice Individual or Group-Based Counseling Telephone and Mobile Phone–Based Interventions

Psychosocial Intervention inPregnant Persons

Intervention recipient Adult smokers motivated to quit. Adult smokers, regardless of motivation to quit.
  • Adult smokers motivated to quit.
  • Most mobile phone–based interventions targeted adults younger than age 45 years. 
Pregnant smokers.
Behavior change goals and techniques
  • Specific “advice” varied but generally included a verbal “stop smoking” message. 
  • Most often, advice was given along with print materials, additional advice from health care staff, or a referral to a cessation clinic.
  • Typically included review of smoking history and motivation to quit, help in the identification of high-risk situations and the generation for problem solving strategies, and nonspecific support and encouragement.
  • Many group-based sessions included cognitive behavioral therapy. Initial sessions focused on discussion of motivation for quitting, health benefits, and strategies for planning a quit attempt.
  • Telephone counseling and mobile phone–based interventions were generally tailored to participants’ smoking history and readiness to quit and focused on increasing motivation and likelihood of quitting.
  • Cognitive behavioral, motivational and supportive therapies that include counseling, health education, feedback, financial incentives, and social support.
Intervention intensity Often a single session lasting less than 20 minutes (with or without print materials) plus up to one followup visit between 1 week and 3 months later.
  • Often one face-to-face session with followup over 1 week to 4 months later.
  • Individual-based counseling given during one face-to-face session with multiple followup sessions in person or via the telephone.
  • Group-based counseling delivered over six to eight sessions.
Varied from 2 weeks to 1 year, with most taking place over 3 to 4 months.

Telephone counseling:

  • 1 to 12 calls.
  • 10 to 20 minutes per call, although the first calls were often longer.
  • Occurred during scheduled telephone calls that began after smokers had first called a smoking quitline.

Mobile phone–based:

  • Less than two messages per day every day over the course of the intervention.
  • Used text messaging.
  • Recruited during first prenatal visit or during second trimester visit and continued through late pregnancy.
  • Frequency and intensity varied. Counseling ranged from a single session <5 minutes to several sessions up to 4 hours per session and has been increasing over time.
Interventionist Physicians (e.g., general practitioners, family practice) or nursing staff. Smoking cessation specialists, often with backgrounds in social work, psychology, psychiatry, health education, and nursing.
  • Telephone counseling provided by professional counselors or trained health care professionals.
  • Text messages were developed and administered through computer expert generated systems.
Varied.
Practice settings Primary care or hospital settings. Hospital or smoking cessation clinic settings. Virtual via telephone or mobile phone; a few studies provided face-to-face support. Women’s health clinic or smoking cessation clinic.
Examples of interventions and materials used in studies Intervention: Morgan, 199666
Material Used: Orleans CT, Rimer BK, Fleisher L. Clear Horizons: A Quit Smoking Guide Especially for Those 50 and Over. Philadelphia: FoxChase Cancer Center; 1989.

Intervention: Canga, 200067
Materials Used: Based on “How to Help Your Patients Stop Smoking: A National Cancer Institute Manual for Physicians”68 and the orientation of the Mayo Nicotine Dependence Center.69

Intervention: Weissfeld, 199170
Material Used: Clearing the Air: How to Quit Smoking and Quit for Keeps. National Cancer Institute; 1987.

Other Interventions:
Fiore 200471

Glasgow 200072
Intervention: Bock, 201373 
Material Used: American Lung Association guide

Intervention: Orleans, 199174
Material Used: A Lifetime of Freedom From Smoking. American Lung Association.

Intervention: McBride, 199975    
Material Used: https://www.cancer.gov/publications/patient-education/clearing-the-air

Other Interventions:
Curry 199576
Ellerbeck 200977

McClure 200578
Intervention: Rigotti, 200679
Material Used: Solomon L, Quinn V. Spontaneous quitting: self-initiated smoking cessation in early pregnancy. Nicotine Tob Res. 2004;6(suppl):S203-216.

Intervention: Windsor 201180
Material Used:  Ask-Advise-Assess-Arrange SCRIPT,11, 78-80 including a video,81 guide to quit smoking,82 and a ≤10- minute counseling session.83

Other Interventions:
Bullock 200984
Lee 201585
Pollak 201386

Stotts 200987
Demonstrated benefit§ Increases the rate of smoking cessation at 6 months or more.
  • Physician advice: 1.76 (95% CI, 1.58 to 1.96). Some evidence suggests that providing additional followup is more effective.
  • Nurse advice: 1.29 (95% CI, 1.21 to 1.38).
Increases the rate of smoking cessation at 6 months or more.
  • Individual counseling: RR, 1.48 (95% CI, 1.34 to 1.64).
  • Group-based therapy: RR, 1.88 (95% CI, 1.52 to 2.33).
Increases the rate of smoking cessation at 6 months or more.
  • Telephone counseling (provided after smoker calls quitline): RR, 1.38 (95% CI, 1.19 to 1.61).
  • Telephone counseling (other settings): RR, 1.25 (95% CI, 1.15 to 1.35).
  • Mobile phone–based interventions: RR, 1.54 (95% CI, 1.19 to 2.00).
Some evidence that interventions were more effective on smokers who were motivated to quit.
  • Increases smoking cessation in late pregnancy: RR, 1.35 (95% CI, 1.23 to 1.48).
  • Interventions more effective when counseling was more intensive, augmented with messages and self-help materials tailored for pregnant women, and included messages about the effects of smoking on both maternal and fetal health with strong advice to quit as soon as possible.
  • Health education, without counseling, was not effective.

* Adapted from Appendix H Table 1 in reference 12 and a modified Template for Intervention Description and Replication (TIDieR) checklist.88
Example interventions are those that demonstrated a positive direction of effect on smoking cessation, were at low risk of bias, and took place in the United States in primary care or a primary care–applicable setting among an unselected sample of adults (i.e., those not selected based on having smoking-related disease or other comorbid conditions). Inclusion of studies and materials are for example purposes only and does not indicate endorsement by the USPSTF.
Materials provided for practice include materials or protocols that were noted within the source study and that were able to be located.
§ Demonstrated benefit of intervention type is based on comparison of that intervention type with a given control and should not be used to compare the effectiveness of one intervention type with another.

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