Varenicline for smoking cessation in bipolar disorder: a randomized, double-blind, placebo-controlled study

Virtually no clinical trials for smoking cessation have been undertaken in bipolar disorder. Varenicline has shown efficacy for smoking cessation, but warnings about neuropsychiatric adverse events have been issued. We assessed the efficacy and safety of varenicline in euthymic bipolar subjects moti...

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Vydáno v:The journal of clinical psychiatry Ročník 75; číslo 7; s. 765
Hlavní autoři: Chengappa, K N Roy, Perkins, Kenneth A, Brar, Jaspreet S, Schlicht, Patricia J, Turkin, Scott R, Hetrick, Michelle L, Levine, Michele D, George, Tony P
Médium: Journal Article
Jazyk:angličtina
Vydáno: United States 01.07.2014
Témata:
Adult
Benzazepines - administration & dosage
Benzazepines - adverse effects
Benzazepines - pharmacology
Bipolar Disorder - drug therapy
Bipolar Disorder - epidemiology
Comorbidity
Double-Blind Method
Female
Humans
Male
Middle Aged
Nicotinic Agonists - administration & dosage
Nicotinic Agonists - adverse effects
Nicotinic Agonists - pharmacology
Quinoxalines - administration & dosage
Quinoxalines - adverse effects
Quinoxalines - pharmacology
Smoking - drug therapy
Smoking - epidemiology
Smoking Cessation - methods
Treatment Outcome
Varenicline
ISSN:1555-2101, 1555-2101
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Shrnutí:Virtually no clinical trials for smoking cessation have been undertaken in bipolar disorder. Varenicline has shown efficacy for smoking cessation, but warnings about neuropsychiatric adverse events have been issued. We assessed the efficacy and safety of varenicline in euthymic bipolar subjects motivated to quit smoking. Clinically stable adult patients with DSM-IV bipolar disorder (n = 60) who smoked ≥ 10 cigarettes per day were randomized to a 3-month, double-blind, placebo-controlled varenicline trial and a 3-month follow-up. Study enrollment was completed from February 2010 through March 2013. Varenicline was dosed using standard titration, and smoking cessation counseling was provided to all patients. The primary outcome was defined as a 7-day point prevalence of self-reported no smoking verified by expired carbon monoxide level < 10 ppm at 12 weeks. Psychopathology and side-effects were assessed at each visit. At 3 months (end of treatment), significantly more subjects quit smoking with varenicline (n/n = 15/31, 48.4%) than with placebo (n/n = 3/29, 10.3%) (OR = 8.1; 95% CI, 2.03-32.5; P < .002). At 6 months, 6 of 31 varenicline-treated subjects (19.4%) remained abstinent compared to 2 of 29 (6.90%) assigned to placebo (OR = 3.2; 95% CI, 0.60-17.6; P = .17). Psychopathology scores remained stable. Ten serious adverse events occurred (n = 6, varenicline; n = 4, placebo). Abnormal dreams occurred significantly more often in varenicline-treated subjects (n/n = 18/31, 61.3%) than in those receiving placebo (n/n = 9/29, 31%; Fisher exact test, P = .04). Eight varenicline-treated and 5 placebo-assigned subjects expressed fleeting suicidal ideation, a nonsignificant difference. Varenicline shows efficacy for initiating smoking cessation in bipolar patients, but medication trials of longer duration are warranted for maintaining abstinence. Vigilance for neuropsychiatric adverse events is prudent when initiating varenicline for smoking cessation in this patient population. ClinicalTrials.gov identifier: NCT01010204.
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ISSN:1555-2101
1555-2101
DOI:10.4088/JCP.13m08756