St. John's Wort for tobacco cessation

圣约翰草用于戒烟

• 批准号: 7123412
• 负责人: AMIT SOOD
• 金额: $ 18.31万
• 依托单位: MAYO CLINIC ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-16 至 2008-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7123412
• 关键词: St Johns wort; alternative medicine; clinical research; drug /alcohol abstinence; drug addiction antagonist; drug screening /evaluation; drug withdrawal; human subject; human therapy evaluation; patient oriented research; smoking cessation

DESCRIPTION (provided by applicant): After a steady decline for the last 50 years, the prevalence of tobacco use in the United States has reached a plateau of approximately 23%. Currently available treatments among adults are expensive and not efficacious for all tobacco users. New pharmacologic agents need to be developed and tested to achieve the Healthy People 2010 goal of less than 12% adult tobacco use prevalence. Bupropion, an FDA approved agent for tobacco cessation, acts by inhibiting central synaptosomal reuptake of dopamine and norepinephrine. A widely used herbal antidepressant, St. John's Wort (SJW), shares a similar mechanism of action and is effective for treating mild to moderate depression. SJW is well tolerated, available over the counter, and is significantly less expensive than the established treatments for tobacco dependence. To date, no prospective clinical trial evaluating the efficacy of SJW for the treatment of tobacco use has been published. We propose to evaluate the efficacy of SJW for decreasing nicotine withdrawal symptoms and for increasing tobacco abstinence in a randomized, double-blind, placebo-controlled, three-arm, parallel group, dose-ranging clinical trial. Participants (N=60) will be randomly assigned to one of the three groups and will receive a twelve-week course of SJW 900 mg per day, 1800 mg per day, or a matching placebo. This proposal is submitted as an R21 that is responsive to the NCCAM program announcement PAR-03-153. This study is anticipated to provide the data needed to develop a larger randomized controlled clinical trial submitted through the R01 funding mechanism to NCCAM.

描述（由申请人提供）：经过过去 50 年的稳步下降，美国的烟草使用率已达到约 23% 的稳定水平。目前成人可用的治疗方法价格昂贵，而且并非对所有烟草使用者都有效。需要开发和测试新的药物制剂，以实现“2010 年健康人民”目标，即成人烟草使用率低于 12%。 安非他酮是 FDA 批准的戒烟药物，通过抑制中枢突触体对多巴胺和去甲肾上腺素的再摄取发挥作用。圣约翰草 (SJW) 是一种广泛使用的草药抗抑郁药，具有相似的作用机制，可有效治疗轻度至中度抑郁症。 SJW 耐受性良好，可在柜台购买，并且比现有的烟草依赖治疗方法便宜得多。 迄今为止，尚未发表评估 SJW 治疗烟草使用功效的前瞻性临床试验。我们建议在一项随机、双盲、安慰剂对照、三组、平行组、剂量范围临床试验中评估 SJW 对减少尼古丁戒断症状和增加烟草戒断的功效。参与者 (N=60) 将被随机分配到三组中的一组，并接受为期 12 周的 SJW 疗程，每天 900 毫克、每天 1800 毫克，或匹配的安慰剂。 该提案作为 R21 提交，以响应 NCCAM 计划公告 PAR-03-153。这项研究预计将提供开发更大规模的随机对照临床试验所需的数据，该试验通过 R01 资助机制提交给 NCCAM。