Cited by 207Smoking Behavior and CessationSubstance Abuse Treatment and OutcomesSchizophrenia research and treatment

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Maintenance Treatment With Varenicline for Smoking Cessation in Patients With Schizophrenia and Bipolar Disorder: A Randomized Clinical Trial

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Evins, A. Eden, Cather, Corinne, Pratt, Sarah A., Pachas, Gladys N., Hoeppner, Susanne S., Goff, Donald C., Achtyes, Eric D., Ayer, David, Schoenfeld, David A.·2014·JAMA

DOI 10.1001/jama.2013.285113PMC PMC4124884

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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 MEASURES: Seven-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. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00621777.

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Authors: Evins, A. E., Cather, C., Pratt, S. A., Pachas, G. N., Hoeppner, S. S., Goff, D. C., Achtyes, E. D., Ayer, D., & Schoenfeld, D. A.
Affiliations: Harvard University (US)
Dartmouth College (US)
NYU Langone Health (US)
Michigan State University (US)
Indiana University Bloomington (US)
ORCID: Evins, A. Eden
Cather, Corinne
Pachas, Gladys N.
Hoeppner, Susanne S.
Goff, Donald C.
Achtyes, Eric D.
Ayer, David
Schoenfeld, David A.
Venue: JAMA
Publisher: American Medical Association (AMA)
Published: 2014-01-08
Volume: 311
Issue: 2
Pages: 145
ISSN: 0002-9955 (ISSN-L)
0098-7484
DOI: 10.1001/jama.2013.285113
PMC: PMC4124884
OpenAlex: W1993729509
Cited by: 207
References: 34
Citations by year: 2026: 2 · 2025: 6 · 2024: 11 · 2023: 11 · 2022: 18 · 2021: 10 · 2020: 22 · 2019: 15 · 2018: 14 · 2017: 17 · 2016: 23 · 2015: 42 · 2014: 14
FWCI: 21.34
Type: journal article
Language: en
Open access: green
www.ncbi.nlm.nih.gov
Locations: JAMA (publishedVersion)
PubMed (publishedVersion)
Europe PMC (PubMed Central) (acceptedVersion)
PubMed Central (acceptedVersion)
Funders: U.S. Public Health Service (05B1MACMHS)
National Institute on Drug Abuse (K24DA030443, K23DA000510, R01DA021245)
Topics: Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Smoking Behavior and Cessation
Health Sciences › Medicine › Epidemiology › Substance Abuse Treatment and Outcomes
Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
Keywords: varenicline, smoking cessation, maintenance pharmacotherapy, relapse prevention, schizophrenia, bipolar disorder, severe mental illness, tobacco use, cognitive behavioral therapy, continuous abstinence, exhaled carbon monoxide, relapse rate, nicotine receptor partial agonist, community mental health services, tobacco dependence treatment
MeSH terms: Varenicline, Adult, Aged, Benzazepines, Bipolar Disorder, Combined Modality Therapy, Double-Blind Method, Female, Humans, Male, Middle Aged, Quinoxalines, Schizophrenia, Tobacco Use Disorder, Cognitive Behavioral Therapy, Smoking Cessation, Treatment Outcome, Nicotinic Agonists, Young Adult

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Maintenance Treatment With Varenicline for Smoking Cessation in Patients With Schizophrenia and Bipolar Disorder: A Randomized Clinical Trial

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