What is the most effective smoking cessation strategy for an adult who wants to quit, including counseling and pharmacologic therapy?

Best Way to Quit Smoking

All adults who smoke should receive combination therapy consisting of both FDA-approved pharmacotherapy (varenicline as first-line agent) and intensive behavioral counseling with at least four sessions over 12 weeks, as this combination achieves 15% abstinence at 6 months compared to only 9% with brief advice alone. 1, 2, 3

Step 1: Initiate the "5 A's" Framework at Every Clinical Encounter

• Ask about tobacco use status at every visit 1
• Advise all tobacco users to quit with a clear, strong, personalized message about health risks and benefits of cessation 1
• Assess willingness to make a quit attempt within the next 30 days 1
• Assist by prescribing pharmacotherapy and arranging behavioral counseling 1
• Arrange follow-up contact within 2 weeks of quit date 1

Step 2: Prescribe First-Line Pharmacotherapy

Varenicline is the most effective single agent, achieving 21.8% abstinence at 6 months versus 16.2% with bupropion, 15.7% with nicotine patch, and 9.4% with placebo. 2

Varenicline Dosing (FDA-Approved)

• Week 1 titration: Days 1-3: 0.5 mg once daily; Days 4-7: 0.5 mg twice daily 4
• Weeks 2-12: 1 mg twice daily, taken after eating with a full glass of water 4
• Set quit date for day 8-35 of treatment (traditionally 1 week after starting medication) 4
• Extended therapy: For patients who successfully quit at 12 weeks, continue an additional 12 weeks (total 24 weeks) to increase long-term abstinence 4

Alternative First-Line Options

• Combination nicotine replacement therapy (NRT): Use nicotine patch (long-acting) plus nicotine gum, lozenge, inhaler, or nasal spray (short-acting) for breakthrough cravings—this is more effective than single-form NRT 1, 2, 5
• Bupropion SR: Achieves 19% abstinence versus 11% with placebo 1
• Combination varenicline + NRT: Some studies show increased quit rates compared to varenicline alone 2

Step 3: Arrange Intensive Behavioral Counseling

Schedule a minimum of four counseling sessions over 12 weeks with total contact time of 90-300 minutes; eight or more sessions provide the greatest benefit, though the incremental gain is not statistically significant. 1

Effective Counseling Modalities (All Evidence-Based)

• In-person individual or group counseling by trained staff (specialists or non-specialists are equally effective) 1
• Telephone quitlines (1-800-QUIT-NOW): Achieve 10.8% cessation versus 7.8% with usual care 1
• Text-messaging programs: Achieve 9.5% cessation versus 5.6% with usual care 1
• Combination approach: Refer to quitline + enroll in text-messaging program for comprehensive support without requiring in-person visits 1

Essential Counseling Components

• Identify smoking triggers and high-risk situations (stress, alcohol, social settings) 1
• Develop coping strategies for nicotine withdrawal symptoms (irritability, anxiety, difficulty concentrating) 1
• Provide problem-solving skills training for difficult situations 1
• Screen for depression and anxiety, which are common causes of relapse and may require separate treatment 1

Step 4: Schedule Follow-Up and Monitor Progress

• First follow-up within 2 weeks of starting pharmacotherapy to assess adherence, side effects, and abstinence 1
• Continue follow-up at minimum 12-week intervals during therapy 1
• Monitor for relapse and encourage repeated quit attempts if relapse occurs—most smokers require an average of 6 quit attempts before achieving long-term abstinence 2

Common Pitfalls to Avoid

• Never provide pharmacotherapy without behavioral support—the combination is substantially more effective than either alone 1, 3
• Do not rely on web-only programs—current evidence is insufficient compared to telephone quitlines and text-messaging 1
• Avoid single-session brief advice (≤30 minutes) as the sole intervention—it is insufficient for most smokers 1
• Do not underestimate the importance of extended pharmacotherapy—12 weeks is the minimum, with 24 weeks recommended for sustained abstinence 1, 4
• Never ignore comorbid mental health conditions—depression and anxiety significantly increase relapse risk 1

Special Population: Pregnant Women

Intensive behavioral counseling is the only first-line intervention with established safety and effectiveness in pregnancy, increasing cessation from 11% to 15% and reducing low-birth-weight risk (RR 0.83). 6, 7

• Deliver at least four counseling sessions (90-300 minutes total) with pregnancy-specific materials about maternal and fetal health effects 6, 7
• Nicotine replacement therapy may be considered only after behavioral counseling fails in moderate-to-high dependence smokers, using intermittent-dose gum rather than continuous-dose patches to minimize fetal nicotine exposure 6
• Bupropion, varenicline, and e-cigarettes are not recommended in pregnancy due to insufficient safety data 6, 7
• Quitting before 15 weeks' gestation provides the greatest fetal benefit 6

Expected Outcomes

• Unassisted quit attempts: 3-5% success at 1 year 8
• Behavioral intervention alone: 7-16% success 8
• Pharmacotherapy + behavioral support: 15-24% success 2, 8
• Varenicline + intensive counseling: Up to 25% success 2