Efficacy and safety of varenicline for smoking cessation in bipolar depressed patients: an open-label 12-week feasibility trial

  • Courtney Prince, Mayo Clinic, United States
  • Jon Ebbert, Mayo Clinic - Rochester, MN, United States
  • Joanna Biernacka, Mayo Clinic - Rochester, MN, United States
  • Cynthia Stoppel, Mayo Clinic, United States
  • Timothy Lineberry, Mayo Clinic, United States
  • Darrell Schroeder, Mayo Clinic, United States
  • Mark Frye, Mayo Clinic, United States

Objective: Conduct a feasibility study to evaluate varenicline for smoking cessation in patients with bipolar depression. The morbidity and mortality of smoking-related illnesses is substantial. This public health problem is only magnified in patients with bipolar disorder as they have one of the highest rates of nicotine dependence and one of the lowest quit rates.

Methods: Thirty patients with bipolar disorder and nicotine dependence enrolled in a 12 week open trial of varenicline in conjunction with a behavior modification educational counseling. Mood/safety and smoking use were closely monitored at 1-2 week intervals.

Results: Baseline ratings of the 1stsubject enrolled included: Fagerstrom Test of Nicotine Dependence (FTND) = 8, Brief Questionnaire of Smoking Urges (QSU-Brief) = 910 out of 1000, Montgomer-Asberg Depression Rating Scale (MADRS) = 13, Young Mania Rating Scale (YMRS) = 0, Carbon Monoxide level = 16. After the 12 week program, the 1st patient met criteria for responder MADRS = 2, Carbon Monoxide level = 3, and smoke free.

Conclusions: The pilot feasibility study was designed to address an important unmet need for smoking cessation therapies in bipolar disorder. Results to date show the use of varenicline for smoking cessation in those with bipolar depression is safe and effective.