Phase IIb Trial of an α7 Nicotinic Receptor Partial Agonist With and Without Nicotine Patch for Withdrawal-Associated Cognitive Deficits and Tobacco Abstinence.
Phase IIb Trial of an α7 Nicotinic Receptor Partial Agonist With and Without Nicotine Patch for Withdrawal-Associated Cognitive Deficits and Tobacco Abstinence.
复制标题
α7 烟碱受体部分激动剂（含或不含尼古丁贴片）治疗戒断相关认知缺陷和戒烟的 IIb 期试验。
DOI：
10.1097/jcp.0000000000000919
复制
发表时间：
2018
影响因子：
2.9
通讯作者：
Evi
中科院分区：
文献类型：
--
作者：
Schuster,RandiMelissa;Pachas,GladysN;Stoeckel,Luke;Cather,Corinne;Nadal,Mireya;Mischoulon,David;Schoenfeld,DavidA;Zhang,Haiyue;Ulysse,Christine;Dodds,ElisabethB;Sobolewski,Sara;Hudziak,Vicenta;Hanly,Ailish;Fava,Maurizio;Evi
方法160例有戒烟动机的成年日吸烟者在满足基线和过夜戒烟后完成认知测试，然后随机接受为期12周的恩西尼克林1 mg每日2次或相同的安慰剂过夜戒烟认知测试。在12周encenicline给药的前6周，参与者也被随机分配到6周的NRT贴剂或安慰剂贴剂。主要结果是戒烟期间的认知和第12周7天的点患病率戒烟。结果与安慰剂相比，或与安慰剂胶囊+ NRT相比，恩西尼克林对认知或戒烟没有有益影响。4个条件，禁欲率最低之间分配到encenicline单独conclusionsBeneficial影响NRT观察到认知和禁欲的结果时，与encenicline加安慰剂补丁相比，与encenicline。与恩赛尼克兰+安慰剂贴剂相比，恩赛尼克兰+NRT可使戒断几率提高约3倍。我们的结论是，作为单药治疗或NRT贴片的辅助治疗，1 mg/d的安西尼克林并不能改善禁欲相关的认知障碍或禁欲率。
MethodsAdult daily smokers, n= 160, who were motivated to quit smoking completed cognitive testing at satiated baseline and after overnight abstinence and then were randomized to receive a 12-week trial of encenicline 1 mg twice daily or identical placebo the day of the overnight abstinent cognitive testing. In the first 6 weeks of the 12-week encenicline administration, participants were also randomized to 6 weeks of NRT patch or placebo patch. Primary outcomes were cognition during abstinence and 7-day point-prevalence abstinence at week 12.ResultsNo beneficial effects of encenicline were observed on cognition or abstinence when compared with placebo or when combined with NRT compared with placebo capsule+ NRT. Of the 4 conditions, abstinence rates were lowest among those assigned to encenicline alone.ConclusionsBeneficial effects of NRT were observed on cognitive and abstinence outcomes when combined with encenicline compared with encenicline plus placebo patch. Addition of NRT to encenicline improved odds of abstinence approximately 3-fold compared with encenicline plus placebo patch. We conclude that encenicline, 1 mg/d, did not improve abstinence-associated cognitive impairment or abstinence rates as monotherapy or adjunctive therapy to NRT patch.