News Release

Longer-term use of smoking cessation medication effective among patients with mental illness

Peer-Reviewed Publication

JAMA Network

Among smokers with schizophrenia or bipolar disease who achieved initial smoking abstinence with a standard 12-week course of the smoking cessation drug varenicline, an additional 40 weeks of treatment resulted in abstinence rates that were three times higher than patients who received placebo, according to a study in the January 8 issue of JAMA.

Although tobacco smoking among adults has declined by 55 percent in the United States since 1965, smoking prevalence among adults with serious mental illness remains higher now than it was in the general population in 1965. Six million of the 11.4 million adults (53 percent) with serious mental illness smoke tobacco (individuals with mental illness smoke at rates approximately twice that of adults without mental disorders). Relatively small trials have reported pharmacologic cessation aids increase initial abstinence rates over behavioral treatment alone for smokers with schizophrenia, suggesting behavioral treatment alone is ineffective for smoking cessation in this population. "Standard courses of pharmacotherapeutic cessation aids improve short-term abstinence, but most who attain abstinence relapse rapidly after discontinuation of pharmacotherapy," according to background information in the article.

A. Eden Evins, M.D., M.P.H., of Massachusetts General Hospital and Harvard Medical School, Boston, and colleagues evaluated the efficacy of longer-term varenicline use and cognitive behavioral therapy (CBT) in smokers with serious mental illness. The trial included 247 smokers with schizophrenia or bipolar disease who received varenicline for 12-weeks and CBT; 87 met abstinence criteria to enter the relapse prevention intervention.

Participants who had 2 weeks or more of continuous abstinence at week 12 of treatment were randomly assigned to receive CBT and varenicline or placebo from weeks 12 to 52. Participants then discontinued study treatment and were followed up to week 76. Eighty-two percent (33 of 40) of those assigned to varenicline and 60 percent (28 of 47) of those receiving placebo remained in the study from weeks 12 through 52.

The researchers found that 24 of 40 patients (60 percent) in the extended-duration varenicline group achieved a biochemically verified (via exhaled carbon monoxide) abstinence rate at week 52 vs. 9 of 47 patients (19 percent) in the placebo group. From weeks 12 through 52, 45 percent of patients achieved continuous abstinence in the varenicline group vs. 15 percent in the placebo group. After treatment discontinuation, by week 76, 30 percent of patients in the varenicline group vs. 11 percent in the placebo group had been continuously abstinent since randomizations at week 12 (for a total of 16 months). Participants assigned to maintenance varenicline had higher continuous-abstinence rates at every post-randomization visit during the 40 weeks of relapse-prevention treatment.

Treatment assignment did not have an effect on severity of psychiatric symptoms, on self-report of overall health, body mass index, or on nicotine withdrawal symptoms.

The authors write that maintenance treatment as indicated in this study "may reduce the high prevalence of tobacco dependence and reduce the heavy burden of smoking-related morbidity and mortality in those with serious mental illness."


(doi:10.1001/jama.2013.285113; Available pre-embargo to the media at

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