A double-blind randomized placebo-controlled pilot study of neuropsychiatric adverse events in abstinent smokers treated with varenicline or placebo.
Biol Psychiatry
; 69(11): 1075-82, 2011 Jun 01.
Article
in En
| MEDLINE
| ID: mdl-21295286
ABSTRACT
BACKGROUND:
Varenicline is an α4ß2 partial nicotinic agonist approved for smoking cessation. There have been spontaneous postmarketing reports of neuropsychiatric adverse events (NPAEs) in smokers without a history of psychiatric illness quitting with varenicline.METHODS:
One hundred ten smokers without history of psychiatric illness (screened by Structured Clinical Interview for DSM-IV) were randomized to 12 weeks of varenicline 1 mg twice daily (n = 55) or placebo. Adverse events were solicited systematically. Depressive symptoms, anxiety, aggression, and irritability were measured at baseline and weekly using the Montgomery-Åsberg Depression Rating Scale (MADRS), the Hamilton Anxiety Scale (HAM-A), and the Overt Aggression Scale-Modified (OAS-M). The Profile of Mood States (POMS) was administered daily. Mixed-model analysis of repeated measures was conducted to compare mean changes in scores between groups across study periods.RESULTS:
Participants' mean baseline characteristics were 33 years of age, 22 cigarettes/day and Fagerström Test for Nicotine Dependence score > 7. Reported NPAEs were similar between groups. No suicidal events were reported. There were no significant differences between groups for the MADRS (treatment difference vs. placebo = .03, 95% confidence interval [CI] -.68-.73; NS), HAM-A (treatment difference [TD] = .14, 95% CI -.62-.90; NS), OAS-M Aggression subscale (TD = .5, 95% CI -1.18-2.18; NS), OAS-M Irritability subscale (TD = .08, 95% CI -.17-.34; NS), and the POMS total scores (TD = .5, 95% CI -.52-1.53; NS).CONCLUSIONS:
There were no significant differences between groups on measures of depressive symptoms, anxiety, or aggression/hostility. Systematically solicited NPAEs were similar between the varenicline and placebo groups.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Quinoxalines
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Tobacco Use Disorder
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Benzazepines
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Smoking
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Smoking Cessation
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Nicotinic Agonists
Type of study:
Clinical_trials
/
Prognostic_studies
/
Qualitative_research
Limits:
Adolescent
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Adult
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Aged
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Female
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Humans
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Male
/
Middle aged
Language:
En
Journal:
Biol Psychiatry
Year:
2011
Document type:
Article
Affiliation country:
Estados Unidos