What is the first-line treatment for tobacco (nicotine) cessation?

Medical Advisory BoardAll articles are reviewed for accuracy by our Medical Advisory Board
Educational purpose only • Exercise caution as content is pending human review
Article Review Status
Submitted
Under Review
Approved

Last updated: April 23, 2025View editorial policy

Personalize

Help us tailor your experience

Which best describes you? Your choice helps us use language that's most understandable for you.

From the Guidelines

The first line treatment for smoking cessation is a combination of behavioral counseling and pharmacotherapy, with varenicline being the most effective pharmacotherapy option, as evidenced by the most recent study 1.

Key Components of Treatment

  • Behavioral counseling: provides support, encouragement, and strategies to manage triggers and withdrawal symptoms
  • Pharmacotherapy: options include nicotine replacement therapy (NRT), varenicline, and bupropion SR

Pharmacotherapy Options

  • Varenicline: starting at 0.5mg daily for 3 days, then 0.5mg twice daily for 4 days, then 1mg twice daily for 12 weeks
  • NRT: available in various forms, including patches, gum, lozenges, inhalers, or nasal spray
  • Bupropion SR: 150mg daily for 3 days, then 150mg twice daily for 7-12 weeks

Combination Therapy

  • Using a combination of NRT products, such as combining short-acting plus long-acting forms of NRT, has been found to be more effective than using a single form of NRT 1
  • Varenicline appears to be more effective than NRT or bupropion SR, based on a smaller number of studies 1

Important Considerations

  • Patient preference, medical history, and previous quit attempts should be taken into account when choosing a treatment option
  • Treatment should be accompanied by a structured quit plan, regular follow-up, and strategies to manage triggers and withdrawal symptoms
  • Behavioral counseling and pharmacotherapy should be used in combination to increase cessation rates, as evidenced by studies 1

From the FDA Drug Label

Varenicline was evaluated in a double-blind, placebo-controlled trial where patients were instructed to select a target quit date between Day 8 and Day 35 of treatment.

Varenicline was evaluated in a 52-week double-blind placebo-controlled study of 1,510 subjects who were not able or willing to quit smoking within four weeks, but were willing to gradually reduce their smoking over a 12 week period before quitting

Varenicline was evaluated in a double-blind, placebo-controlled trial of patients who had made a previous attempt to quit smoking with varenicline, and either did not succeed in quitting or relapsed after treatment. The first line treatment for smoking cessation is varenicline.

  • Key points:
    • Varenicline had a superior rate of CO-confirmed abstinence during weeks 9 through 12 and from weeks 9 through 52 compared to placebo in multiple studies 2.
    • Varenicline was effective in patients with chronic obstructive pulmonary disease (COPD) and cardiovascular disease.
  • Dosage: Varenicline 1 mg twice daily. The evidence supports the use of varenicline as a first line treatment for smoking cessation 2.

From the Research

First-Line Treatment for Smoking Cessation

  • The first-line treatment for smoking cessation should include both pharmacotherapy and behavioral support, with varenicline or combination nicotine replacement therapy (NRT) as preferred initial interventions 3.
  • Combining medication and behavioral counseling is associated with a higher quit rate compared to brief advice or usual care, with a quit rate of 15.2% over 6 months 3.
  • Varenicline has been shown to have a significantly higher 6-month quit rate (21.8%) compared to bupropion (16.2%) and the nicotine patch (15.7%) 3.

Pharmacotherapy Options

  • Nicotine replacement therapy (NRT), bupropion, and varenicline are approved by the U.S. Food and Drug Administration as first-line treatments for smoking cessation 4, 5.
  • Combination NRT and varenicline have been shown to have the greatest smoking cessation rates 5.
  • Clonidine and nortriptyline are second-line treatments used when first-line treatments fail or are contraindicated, or by patient preference 5.

Behavioral Interventions

  • Behavioral interventions, such as counseling, can increase quit rates, but effectiveness varies depending on the characteristics of the support provided 6.
  • There is high-certainty evidence of benefit for the provision of counseling and guaranteed financial incentives 6.
  • Evidence suggests possible benefit for individual tailoring, delivery via text message, email, and audio recording, and intervention content with motivational components and a focus on how to quit, but further studies are needed to evaluate these components 6.

Combination Therapy

  • Combining pharmacotherapy with behavioral support is significantly more effective than either approach alone 3, 4.
  • The effect of behavioral support for smoking cessation appears slightly less pronounced when people are already receiving smoking cessation pharmacotherapies 6.

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Research

Smoking Cessation Interventions.

American family physician, 2022

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

Have a follow-up question?

Our Medical A.I. is used by practicing medical doctors at top research institutions around the world. Ask any follow up question and get world-class guideline-backed answers instantly.