Varenicline (Champix) Treatment Protocol for Smoking Cessation
Varenicline is the most effective single pharmacotherapy for smoking cessation and should be used as a first-line treatment option with a standard 12-week course, followed by an additional 12-week course for successful quitters to maximize long-term abstinence. 1, 2, 3
Dosing Regimen
Begin varenicline 1-2 weeks before the quit date with a titrated dosing schedule 1, 2, 3:
- Days 1-3: 0.5 mg once daily
- Days 4-7: 0.5 mg twice daily
- Day 8 to end of treatment: 1 mg twice daily
Standard treatment duration is 12 weeks, with an additional 12-week course recommended for patients who successfully quit to further increase long-term abstinence 1, 2, 3
Take medication after eating and with a full glass of water to minimize gastrointestinal side effects 3
Efficacy and Advantages
Varenicline is more effective than bupropion or nicotine replacement therapy (NRT), with meta-analyses showing a relative risk of 1.39 versus bupropion and 1.25 versus NRT for smoking abstinence 1
Varenicline works as a partial agonist/antagonist at α4β2 nicotinic acetylcholine receptors, reducing both withdrawal symptoms and smoking satisfaction 4, 5
Continuous abstinence rates at weeks 9-12 range from 43.9% to 65.4% with varenicline compared to significantly lower rates with placebo 6
Long-term abstinence rates (52 weeks) remain significantly higher with varenicline compared to placebo, bupropion SR, and nicotine replacement therapy 6
Monitoring and Follow-up
Schedule follow-up within 2-3 weeks after starting pharmacotherapy to assess side effects and compliance 1, 2
Additional follow-up is recommended at 12-week intervals during therapy and after completion 1
Monitor for neuropsychiatric symptoms, including depression and suicidal ideation/behavior, particularly in patients with a history of psychiatric illness 1, 3
Track quit attempts and consider switching to a different pharmacotherapy if reduction efforts stall or abstinence seems unlikely 1
Side Effects Management
Nausea is the most common side effect (30-40% of users), typically mild to moderate and diminishing over time 2, 6
Other common side effects include insomnia (14.2%) and headache (14.2%) 6
Consider temporary or permanent dose reduction in patients who cannot tolerate adverse effects 3
Special Populations
For patients with severe renal impairment (creatinine clearance <30 mL/min), start with 0.5 mg once daily, with maximum dose of 0.5 mg twice daily 3
For end-stage renal disease patients on hemodialysis, maximum dose is 0.5 mg once daily 3
Contraindicated in patients with brain metastases due to seizure risk 1
Safe and effective in patients with stable cardiovascular disease, with no significant increase in cardiovascular events or mortality 7
Behavioral Support
Always combine varenicline with behavioral therapy to maximize success rates 1, 2
Behavioral support should include skills training, social support, and motivational interviewing 1
Recommend at least four counseling sessions during the 12-week course, with sessions lasting 10-30+ minutes 2
For patients who continue to smoke or relapse, consider intensifying behavioral therapy with referral to specialty care (psychiatrist, psychologist) 1
By following this comprehensive treatment protocol, healthcare providers can optimize the use of varenicline (Champix) to help patients successfully quit smoking and reduce their risk of smoking-related morbidity and mortality.