in progress

Final Research Plan

Tobacco Cessation in Adults: Interventions

July 17, 2025

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.

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Figure 1 is an analytic framework that depicts the three Key Questions (KQs) to be addressed in the systematic review. Specifically, it illustrates the following questions: whether tobacco cessation interventions improve health outcomes in adults who currently use tobacco, including those who are pregnant (KQ1); whether tobacco cessation interventions iincrease tobacco abstinence in adults who currently use tobacco, including those who are pregnant (KQ2); and whether there are harms associated with tobacco cessation interventions in adults, including those who are pregnant (KQ3).

*Tobacco use includes the use of cigarettes, cigars, dissolvables, hookah tobacco, nicotine gels, pipe tobacco, roll-your-own tobacco, smokeless tobacco products including dip, snuff, snus, and chewing tobacco, e-cigarettes, vapes, and other electronic nicotine delivery systems (ENDS), and other non-tobacco-nicotine products such as nicotine pouches.

  1. Do tobacco cessation interventions improve health outcomes in adults who currently use tobacco, including those who are pregnant?
  2. Do tobacco cessation interventions increase tobacco abstinence* in adults who currently use tobacco, including those who are pregnant?
  3. What harms are associated with tobacco cessation interventions in adults, including those who are pregnant?

* Where available, the evidence will be synthesized by the specific tobacco or nicotine product being used.

 Contextual questions will not be systematically reviewed and are not shown in the Analytic Framework.

  1. What are the considerations related to the use of e-cigarettes and other nicotine delivery products?
  2. What is the evidence on novel tobacco cessation interventions (e.g. transcranial magnetic stimulation, psilocybin, and glucagon-like peptide-1 receptor agonists)?
  3. What factors are associated with access to and utilization of tobacco cessation interventions?
  4. What strategies and programs facilitate access to or utilization of tobacco cessation interventions?

For key questions, we will describe the population characteristics of the included studies to assess the degree to which the evidence is representative across populations. We will also examine selected subgroup analyses reported in the included studies to explore the extent to which the benefits or harms may vary by population or intervention characteristics. We will report results by the specific tobacco and/or nicotine product and product characteristic (e.g., menthol flavoring, synthetic nicotine) being examined and will evaluate any variation in the benefits and harms according to the product and product characteristics.

The Research Approach identifies the study characteristics and criteria that the Evidence-based Practice Center will use to search for publications and to determine whether identified studies should be included or excluded from the Evidence Review. Criteria are overarching as well as specific to each of the key questions.

Category Included Excluded
Aim Tobacco cessation in adults who currently use tobacco, regardless of readiness to quit, including relapse prevention
  • Primary prevention of tobacco use
  • Tobacco harm-reduction strategies
Condition Current use of any commercial tobacco or nicotine product, including but not limited to cigarettes, cigars, dissolvables, hookah tobacco, nicotine gels, pipe tobacco, roll-your-own tobacco, smokeless tobacco products including dip, snuff, snus, and chewing tobacco, and e-cigarettes, vapes, other electronic nicotine delivery systems (ENDS), and nicotine pouches.

Includes products that include naturally occurring nicotine (nicotine derived from tobacco plants) and non-tobacco nicotine (“synthetic” nicotine).

  
Population Adults (age ≥18 years), including those who are pregnant and persons with serious mental illnesses who currently use tobacco. Reviews and studies limited to:
  • Children and adolescents
  • Persons with existing tobacco-related illness (e.g., chronic obstructive pulmonary disease, lung cancer)
Interventions Primary care–relevant tobacco cessation interventions that can be provided in primary care or are feasible to refer to from primary care, including FDA-approved pharmacotherapy (i.e., nicotine replacement therapy, bupropion, and varenicline) and behavioral interventions, alone or in combination.
  • Non-FDA approved therapies and devices (e.g., electronic cigarettes, nicotine pouches)
  • Broad public health initiatives (e.g., mass media, community-wide campaigns), inpatient programs
Setting Any setting applicable to primary care, including interventions that take place in settings that can be referred to from primary care Reviews and studies limited to interventions that take place in worksites, churches, or other settings where participants have existing social connections
Comparators
  • No intervention
  • Usual care
  • Placebo
  • Waitlist
  • Attention control (e.g., intervention is similar in format and intensity but on a different content area)
  • Minimal intervention (no more than a single brief contact [i.e., <5 minutes] per year, brief written materials, such as pamphlets, or self-help materials)
  • Active intervention (i.e., more than a single brief contact per year or brief written materials, or another cessation medication)
  
Outcome assessment Tobacco use based on self-report or biochemically validated reports (e.g., expired carbon monoxide; cotinine measured in saliva, urine, or blood; cotinine–creatinine ratio; thiocyanate). Where available, the specific tobacco and/or nicotine product will be specified. Population-based smoking rates (i.e., not based on study sample but on underlying population)
Outcomes KQ 1 (health outcomes):
  • All-cause mortality
  • Tobacco-related mortality
  • Tobacco-related morbidity (including but not limited to cancer, asthma, cardiovascular disease, chronic bronchitis, or other respiratory disorders)
  • Maternal and perinatal morbidity/mortality
  • Mental health outcomes
  • Dental/oral health
  • Quality of life

KQ 2 (behavioral outcomes): Tobacco cessation/tobacco abstinence (continuous or point prevalence abstinence)

Cessation outcomes will be stratified by specific tobacco or nicotine product when possible.

KQ 3 (harms): Serious treatment-related harms at any time point after the intervention began
  • Reduction in the quantity or frequency of tobacco use
  • Reduction in withdrawal symptoms
  • Attitudes, knowledge, or beliefs related to tobacco use
  • Intentions to change behavior
  • Intervention participation/compliance
Outcome assessment timing KQs 1, 2: ≥6-month followup after quit date or start of intervention

KQ 3: Harms reported at any point after quit date		 <6-month followup after quit date or start of intervention
Study design Pharmacotherapy and behavioral interventions in adults:
  • Existing Cochrane Collaboration systematic reviews that synthesize evidence meeting the inclusion and exclusion criteria for this update
  • Existing systematic reviews addressing populations and/or interventions not covered by the included Cochrane reviews

Behavioral interventions in those who are pregnant:

  • Systematic reviews, including reviews-of-reviews, with or without meta-analysis

Pharmacotherapy in those who are pregnant:

  • Randomized clinical trials
  • Nonrandomized studies of interventions (with concurrent control group) and observational cohort studies (n≥1,000) (KQ 3 only)
  
Study geography Reviews and primary studies that primarily take place in countries categorized as “Very High” on the 2022 Human Development Index (as defined by the United Nations Development Programme) Reviews limited to countries not categorized as “Very High” on the Human Development Index
Countries Studies conducted in countries categorized as “Very High” on the Human Development Index (as defined by the United Nations Development Program) Studies conducted in countries that are not categorized as “Very High” on the Human Development Index
Publication Language English Any language other than English
Quality rating Reviews: High-, moderate-, and low-credibility existing systematic reviews

Primary studies: Fair- and good-quality studies		 Reviews: Very low-credibility existing systematic reviews

Primary studies: Poor-quality studies

Abbreviations: ENDS = electronic nicotine delivery systems; FDA = U.S. Food and Drug Administration; KQ = key question.

The draft Research Plan was posted for public comment on the USPSTF Web site from February 27, 2025, to March 26, 2025. In response to public comments, we clarified that this review focuses specifically on commercial tobacco products, includes placebo-controlled trials, includes mental health outcomes as eligible health outcomes, and excludes studies limited to people with existing tobacco-related illnesses such as lung cancer. We clarified that interventions and outcomes will be described by the specific tobacco or tobacco products being addressed and reported where possible. Additionally, only therapies approved by the FDA for tobacco or smoking cessation and behavioral interventions will be included as eligible interventions. Therefore, studies evaluating the use of non-FDA-approved therapies for tobacco or smoking cessation such as e-cigarettes, nicotine pouches, and cytisine/cytisinicline will not be included as eligible interventions. If additional therapies or devices become FDA-approved for tobacco or smoking cessation over the course of this review update, we will amend this protocol to reflect the inclusion of these treatments. Furthermore, a contextual question was added to examine considerations surrounding the use of e-cigarettes, other ENDS, and nicotine pouches given their high prevalence of use.