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Maintenance treatment with varenicline improves smoking cessation in patients with schizophrenia and bipolar disorder

Clinical Question:
Will maintenance treatment with varenicline improve prolonged tobacco abstinence rates in adult smokers with serious mental illness?

Bottom Line:
Adults with serious mental illness, including schizophrenia and bipolar disorder, who achieve tobacco abstinence after an initial 12-week treatment with standard-dose varenicline (Chantix) are significantly less likely to relapse with extended varenicline treatment for an additional 40 weeks. (LOE = 1b)

Evins AE, Cather C, Pratt SA, et al. Maintenance treatment with varenicline for smoking cessation in patients with schizophrenia and bipolar disorder. A randomized clinical trial. JAMA 2014;311(2):145-154  [PMID:24399553]

Study Design:
Randomized controlled trial (double-blinded)

Industry + govt


Outpatient (any)

Adult smokers with serious mental illness, including schizophrenia and bipolar disorder, who quit smoking usually relapse quickly after short-term abstinence. These investigators identified adults (N = 203), aged 18 years to 70 years, with known schizophrenia spectrum disorder (91%) or bipolar disorder (9%), who reported smoking 10 or more cigarettes daily for at least 1 year. Eligible patients were also taking a clinically appropriate dose of antipsychotic or mood-stabilizing medication at the time of enrollment. Patients initially received 12-week therapy with standard dose varenicline and weekly 1-hour group, relapse-prevention-focused, cognitive behavior therapy (CBT) sessions. At the end of 12 weeks, 87 individuals who met the criteria for tobacco abstinence (self-report of smoking no cigarettes in the past 7 days confirmed biochemically by expired carbon monoxide of < 9 ppm) randomly received assignment (concealed allocation) to continue taking varenicline, 1.0 mg twice daily, or a matched placebo for weeks 12 through 52. All participants also received a tapering schedule of CBT (weekly for 1 month, biweekly for 2 months, and then once monthly for a total of 15 sessions). After 52 weeks, all smoking cessation treatment was discontinued. Individuals who assessed outcomes remained masked to treatment group assignment. Complete follow-up occurred for 68% of participants at 76 weeks. Participants who discontinued the study and for whom no further information on smoking behavior was available were considered to have relapsed at the time of dropout. Using intention-to-treat analyses, significantly more patients in the extended-duration varenicline group achieved biochemically verified, 7-day abstinence at week 52 and week 72 compared with those in the placebo group (60% vs 19%; number needed to treat [NNT] = 2.4; 95% CI, 1.8 - 4.9; and 30% vs 11%; NNT = 5.2; 2.8 - 40.4, respectively). There were no effects of treatment group assignment on self-reported psychiatric symptoms or body mass index.


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