A double-blind randomized placebo-controlled pilot study of neuropsychiatric adverse events in abstinent smokers treated with XXXX or placebo.

@entity1 @entity308 @entity4006 @entity146 @entity1239 @entity148 @entity35166 @entity734 @entity34
BACKGROUND: @entity4006 is an a4b2 partial nicotinic agonist approved for smoking cessation. There have been spontaneous postmarketing reports of neuropsychiatric adverse events (NPAEs) in smokers without a history of @entity146 quitting with @entity4006 . METHODS: One hundred ten smokers without history of @entity146 (screened by Structured Clinical Interview for DSM-IV) were randomized to 12 weeks of @entity4006 1 mg twice daily (n = 55) or placebo. Adverse events were solicited systematically. @entity308 , @entity148 , @entity146 , and @entity146 were measured at baseline and weekly using the Montgomery-  sberg Depression Rating Scale (MADRS), the Hamilton Anxiety Scale (HAM-A), and the Overt Aggression Scale-Modified ( @entity35166 -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: @entity1 ' mean baseline characteristics were 33 years of age, 22 cigarettes/day and Fagerstr  m Test for @entity1239 @entity734 score > 7. Reported NPAEs were similar between groups. No suicidal events were reported. There were no significant differences between groups for the MADRS ( @entity34 vs. placebo = .03, 95% confidence interval [CI] -.68-.73; NS), HAM-A ( @entity34 [ @entity34 ] = .14, 95% CI -.62-.90; NS), @entity35166 -M Aggression subscale ( @entity34 = .5, 95% CI -1.18-2.18; NS), @entity35166 -M Irritability subscale ( @entity34 = .08, 95% CI -.17-.34; NS), and the POMS total scores ( @entity34 = .5, 95% CI -.52-1.53; NS). CONCLUSIONS: There were no significant differences between groups on measures of @entity308 , @entity148 , or @entity146 /hostility. Systematically solicited NPAEs were similar between the @entity4006 and placebo groups.
