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）：在过去50年中稳步下降之后，美国使用烟草的流行率达到了约23％的高原。目前，成年人的可用治疗量昂贵，对于所有烟草使用者而言并不有效。需要开发和测试新的药理学剂，以实现不到12％的成人烟草使用率的健康人的目标。 Bupropion是FDA批准的烟草戒烟的药物，它通过抑制多巴胺和去甲肾上腺素的中央突触体再摄取作用。一种广泛使用的草药抗抑郁药St. John's Wort（SJW）具有类似的作用机理，可有效治疗轻度至中度抑郁症。 SJW的耐受性良好，可在柜台上可用，并且比确定的烟草依赖治疗方法要便宜得多。 迄今为止，尚未发表任何评估SJW治疗烟草使用功效的前瞻性临床试验。我们建议评估SJW在随机，双盲，安慰剂对照的，三臂，平行组，剂量范围的临床试验中，SJW降低尼古丁戒断症状和增加烟草戒酒的疗效。参与者（n = 60）将随机分配给三组之一，并将获得12周的SJW 900毫克，每天1800毫克或匹配的安慰剂。 该提案被提交为R21，对NCCAM计划公告有回应 PAR-03-153。预计这项研究将提供所需的数据，以开发通过NCCAM的R01资金机制提交的更大的随机对照临床试验。