TYROSINE FOR METHAMPHETAMINE DEPENDENCE

描述：（申请人摘要） 甲基苯丙胺（MA）依赖在美国迅速扩大， 重现了20世纪50年代和60年代流行病传播的早期阶段。 除了与成瘾直接相关的发病率和死亡率之外， 鉴于艾滋病毒的流行，MA尤其令人担忧，因为它 是静脉注射的，因为它能增加性欲 慢性MA使用中的儿茶酚胺受体增殖及其相似性 MA戒断和重度抑郁症之间的关系，早已为人所知，但 最小的努力已经应用于确定药物治疗是否可以 帮助实现从MA禁欲。 酪氨酸是饮食中 在小型试验中取得了积极的结果， 抗抑郁功效，完全阻断去甲肾上腺素消耗 减少MA在动物中的作用，并减少MA在动物中的自我给药。 本申请提出了一项为期12周的双盲安慰剂对照研究。 一项临床试验，以测试酪氨酸在减少MA中MA使用方面的疗效 依赖的对象。 100例DSM-IV诊断为MA的受试者 依赖将被随机分配接受酪氨酸，2克，或 安慰剂，每日三次。 受试者将接受三次药物治疗 个月;将在第4个月进行随访评估。 研究药物 将被添加到强化门诊药物治疗中。 本研究将 在戒毒、康复和善后方案中进行 海特阿什伯里免费诊所，一个以社区为基础的非营利诊所 在加利福尼亚州的旧金山弗朗西斯科。 完成基线测量后，受试者 将每周评估一次，以确定其对研究的依从性 药物，以确定他们使用MA和其他药物，以完成 评分量表，以获得尿液标本，并分配他们下周的 药品供应。 数据收集工具将包括 成瘾严重程度指数、症状自评量表、贝克抑郁量表 清单，艾滋病行为的风险和治疗服务审查。 主要疗效指标为：MA使用天数， 持续禁欲和治疗保留。 预先计划的分析将 使用生存分析和方差分析比较酪氨酸和 安慰剂和性别与研究药物相互作用。

DESCRIPTION: (Applicant's Abstract) Methamphetamine (MA) dependence is expanding rapidly in the United States, recapitulating early phases of epidemic spread in the 1950's and 1960's. Beyond the morbidity and mortality directly associated with addictive disease, MA is of particular concern in light of the HIV epidemic because it is administered intravenously and because it increases libido. Catecholamine receptor proliferation in chronic MA use, and similarities between MA withdrawal and major depression, have long been known, yet minimal effort has been applied to determine whether pharmacotherapy may be of help in achieving abstinence from MA. Tyrosine is the dietary precursor to catecholamines, has yielded positive results in small trials of its antidepressant efficacy, completely blocks the norepinephrine depleting effects of MA in animals, and reduces MA self-administration in animals. This application proposes a 12 week, double-blind, placebo-controlled clinical trial to test the efficacy of tyrosine in reducing MA use in MA dependent subjects. One hundred subjects with DSM-IV diagnoses of MA dependence will be randomly assigned to receive either tyrosine, 2 grams, or placebo, three times daily. Subjects will receive medication for three months; follow-up evaluation will be conducted at month 4. Study medication will be added to intensive outpatient drug treatment. The study will be conducted at the Drug Detoxification, Rehabilitation and Aftercare Program of the Haight Ashbury Free Clinics, a community based, not-for-profit clinic in San Francisco, CA. Following completion of baseline measures, subjects will be assessed weekly to determine their compliance with study medications, to ascertain their use of MA and other drugs, to complete rating scales, to obtain a urine specimen, and to dispense their next week's supply of medication. Data collection instruments will include the Addiction Severity Index, the Symptom Checklist-90, the Beck Depression Inventory, the Risk for AIDS Behaviors, and the Treatment Services Review. Primary efficacy measures are: days of MA use, continuous abstinence, and treatment retention. Pre-planned analyses will use survival analyses and analysis of variance to compare tyrosine and placebo and gender by study drug interaction.