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Maintenance Treatment With Varenicline for Smoking Cessation in Patients With Schizophrenia and Bipolar Disorder: A Randomized Clinical Trial
Open accessAbstract
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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“All studies were in favor of the specific treatment.”
From The detrimental effects of smoking on the course and outcome in adults with bipolar disorder—A narrative review (2023) · cites this paper as [74]
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“We identified only four published smoking cessation treatment trials in smokers with BD: one very small open pilot study with bupropion (70), two open pilot studies with varenicline (71, 72), and 2 studies using varenicline either alone (73) or in combination with CBT (74).”
From The detrimental effects of smoking on the course and outcome in adults with bipolar disorder—A narrative review (2023) · cites this paper as [74]
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“Six of eight published studies focused on smoking cessation for people with BD have sample sizes of twenty or less”
From Smokers with bipolar disorder, other affective disorders, and no mental health conditions: Comparison of baseline characteristics and success at quitting in a large 12-month behavioral intervention randomized trial. (2018) · cites this paper as Evins et al., 2014
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Metadata
- 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
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 2014-01-08
- Volume
- 311
- Issue
- 2
- Pages
- 145
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- 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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