Wilens Timothy E, Adler Lenard A, Weiss Margaret D, Michelson David, Ramsey Janet L, Moore Rodney J, Renard Didier, Brady Kathleen T, Trzepacz Paula T, Schuh Leslie M, Ahrbecker Lisa M, Levine Louise R
Massachusetts General Hospital, 55 Fruit Street, YAW 6900, Boston, MA 02114, USA.
Drug Alcohol Depend. 2008 Jul 1;96(1-2):145-54. doi: 10.1016/j.drugalcdep.2008.02.009. Epub 2008 Apr 9.
Adults with attention-deficit/hyperactivity disorder (ADHD) have higher rates of alcohol and drug use disorders than adults without ADHD. The study aim was to determine if atomoxetine was superior to placebo in improving ADHD and alcohol use in recently abstinent adults with ADHD and comorbid alcohol use disorder.
Adults with DSM-IV diagnoses of ADHD and alcohol abuse and/or dependence were abstinent from alcohol at least 4 days (maximum 30 days) before study randomization. Participants received atomoxetine (25-100mg daily) or placebo for 12 weeks. ADHD symptoms were assessed using ADHD Investigator Symptom Rating Scale (AISRS) total score. Time-to-relapse to heavy alcohol use was analyzed using a 2-sided log-rank test based on Kaplan-Meier estimates and cumulative heavy drinking events over time were evaluated post hoc with recurrent-event analysis.
Subjects received atomoxetine (n=72) or placebo (n=75) and 80 subjects completed the 12-week double-blind period (n=32 and 48, respectively). ADHD symptoms were significantly improved in the atomoxetine cohort compared to placebo (AISRS total score mean [S.D.], atomoxetine: -13.63 [11.35], P<.001; placebo: -8.31 [11.44], P<.001, difference: P=.007; effect size=0.48). No significant differences between treatment groups occurred in time-to-relapse of heavy drinking (P=.93). However, cumulative heavy drinking days were reduced 26% in atomoxetine-treated subjects versus placebo (event ratio=0.74, P=.023). There were no serious adverse events or specific drug-drug reactions related to current alcohol use.
This 3-month, double-blind, placebo-controlled study of atomoxetine in adults with ADHD and comorbid alcohol use disorder demonstrates clinically significant ADHD improvement, and inconsistent effects on drinking behavior.
患有注意力缺陷多动障碍（ADHD）的成年人比没有ADHD的成年人有更高的酒精和药物使用障碍发生率。本研究的目的是确定在改善近期戒酒的患有ADHD和合并酒精使用障碍的成年人的ADHD及酒精使用方面，托莫西汀是否优于安慰剂。
患有DSM-IV诊断的ADHD和酒精滥用及/或依赖的成年人在研究随机分组前至少戒酒4天（最长30天）。参与者接受托莫西汀（每日25-100mg）或安慰剂治疗12周。使用ADHD研究者症状评定量表（AISRS）总分评估ADHD症状。使用基于Kaplan-Meier估计的双侧对数秩检验分析重度饮酒复发时间，并使用复发事件分析事后评估随时间累积的重度饮酒事件。
受试者接受托莫西汀（n=72）或安慰剂（n=75），80名受试者完成了12周的双盲期（分别为n=32和48）。与安慰剂相比，托莫西汀组的ADHD症状有显著改善（AISRS总分均值[标准差]，托莫西汀：-13.63[11.35]，P<.001；安慰剂：-8.31[11.44]，P<.001，差异：P=.007；效应大小=0.48）。治疗组之间在重度饮酒复发时间上没有显著差异（P=.93）。然而，与安慰剂相比，托莫西汀治疗的受试者累积重度饮酒天数减少了26%（事件比率=0.74，P=.023）。没有与当前酒精使用相关的严重不良事件或特定药物相互作用。
这项针对患有ADHD和合并酒精使用障碍的成年人进行的为期3个月的双盲、安慰剂对照的托莫西汀研究表明，ADHD有临床显著改善，且对饮酒行为的影响不一致。
