Maintenance Treatment With Varenicline for Smoking Cessation in Patients With Schizophrenia and Bipolar Disorder

Abstract

IMPORTANCE It is estimated that more than half of those with serious mental illness smoke tobacco regularly. Standard courses of pharmacotherapeutic cessation aids improve short-term abstinence, but most who attain abstinence relapse rapidly after discontinuation of pharmacotherapy.OBJECTIVE To determine whether smokers diagnosed with schizophrenia and bipolar disease have higher rates of prolonged tobacco abstinence with maintenance pharmacotherapy than with standard treatment. DESIGN, SETTING, AND PARTICIPANTS Randomized, double-blind, placebo-controlled, parallel-group, relapse-prevention clinical trial conducted in 10 community mental-health centers. Of 247 smokers with schizophrenia or bipolar disease recruited from March 2008-April 2012, 203 received 12-weeks' open-label varenicline and cognitive behavioral therapy and 87 met abstinence criteria to enter the relapse prevention intervention.INTERVENTIONS Participants who had 2 weeks or more of continuous abstinence at week 12 of open treatment were randomly assigned to receive cognitive behavioral therapy and double-blind varenicline (1 mg, 2 per day) or placebo from weeks 12 to 52. Participants then discontinued study treatment and were followed up to week 76. MAIN OUTCOMES AND MEASURESSeven-day rate of continuous abstinence at study week 52, the end of the relapse-prevention phase, confirmed by exhaled carbon monoxide. Secondary outcomes were continuous abstinence rates for weeks 12 through 64 based on biochemically verified abstinence and weeks 12 through 76, based on self-reported smoking behavior.RESULTS Sixty-one participants completed the relapse-prevention phase; 26 discontinued participation (7 varenicline, 19 placebo) and were considered to have relapsed for the analyses; 18 of these had relapsed prior to dropout. At week 52, point-prevalence abstinence rates were 60% in the varenicline group (24 of 40) vs 19% (9 of 47) in the placebo group (odds ratio [OR], 6.2; 95% CI, 2.2-19.2; P < .001). From weeks 12 through 64, 45% (18 of 40) among those in the varenicline group vs 15% (7 of 47) in the placebo group were continuously abstinent (OR, 4.6; 95% CI, 1.5-15.7; P = .004), and from weeks 12 through 76, 30% (12 of 40) in the varenicline group vs 11% (5 of 47) in the placebo group were continuously abstinent (OR, 3.4; 95% CI, 1.02-13.6; P = .03). There were no significant treatment effects on psychiatric symptom ratings or psychiatric adverse events.CONCLUSIONS AND RELEVANCE Among smokers with serious mental illness who attained initial abstinence with standard treatment, maintenance pharmacotherapy with varenicline and cognitive behavioral therapy improved prolonged tobacco abstinence rates compared with cognitive behavioral therapy alone after 1 year of treatment and at 6 months after treatment discontinuation.

Combination Extended Smoking Cessation Treatment Plus Home Visits for Smokers With Schizophrenia: A Randomized Controlled Trial

“…Prior studies using extended treatment (6 months or more) have demonstrated the utility of maintenance treatment with a single medication, such as NRT 76 or varenicline, 77 once a smoker with schizophrenia has attained an initial period of abstinence. In addition, a prior open-label study with CBT (for 12 weeks), bupropion, and NRT for 1 year demonstrated the feasibility of this approach, with a substantial quit rate of 23.5%, 78 but no control group using TAU.…”

Expanding Cessation Pharmacotherapy Via Videoconference Educational Outreach to Prescribers

“…22,23 Psychiatric providers are ideally positioned to treat patients who smoke for nicotine dependence during routine office visits. However, psychiatrists and psychiatric nurse practitioners generally lack basic training regarding evidence-based treatment for nicotine dependence, and, in addition to knowledge and skills barriers, they may harbor attitudinal barriers to treating nicotine dependence.…”

Treating smokers in substance treatment with contingent vouchers, nicotine replacement and brief advice adapted for sobriety settings

“…For example, varenicline has shown to result in significantly higher rates of abstinence in smokers with SUD 3 and 6 months after starting it (Rohsenow et al, under review), suggesting that CV plus varenicline might be an effective way to increase both initial abstinence and maintenance of abstinence in smokers with SUD, particularly since varenicline reduces relapse rate in smokers attaining initial abstinence (Evins et al, 2014;Tonstad et al, 2006). Since higher levels of withdrawal discomfort predict less smoking abstinence during and after CV for smokers with SUD (Rohsenow, Tidey, Kahler, Martin, Colby, & Sirota, 2015), combining voucher-based smoking treatments with other pharmacotherapies that reduce craving or withdrawal are likely to increase withintreatment abstinence during CV, as the present results suggest.…”