Psychological And Methodological Issues In Substance Abu

在这个项目中，我们试图增加的文献证明美沙酮维持的好处，并提高这些好处。 我们已经完成了一项研究，以评估在美沙酮维持期间月经周期是否变得更有规律。当海洛因？的月经中断已被证明，很少有关于美沙酮维持和月经功能的公开数据。我们回顾性研究了来自两项临床试验的191名吸毒妇女的数据，持续25-29周;每位妇女维持70-100 mg美沙酮。收集每次月经的开始/结束日期。月经模式分为规律、不规律、短暂性闭经、持续性闭经或周期重启。重复测量回归模型用于确定周期长度的相关性以及长周期（>40天）和短周期（<20天）的预测因子。出血事件（从？开始吗？到哪里去？停止？）定义为一个或多个出血日，至少有两个非出血日。检查的相关因素/预测因素为体重指数、药物使用、美沙酮剂量和种族。在133名可以确定月经模式的妇女中，周期长度不规则是常见的;观察到的模式是：不规则，62（46.7%）;规则，37（27.8%）;周期重新开始，16（12%）;持续闭经，11（8.3%）;短暂闭经，7（5.3%）。美沙酮维持治疗每增加一周与长周期（OR=0.96，p=0.001）和短周期（OR=0.92，p=0.001）风险降低相关。在27名研究前继发性闭经的妇女中，16名（59%）在维持美沙酮治疗的同时重新开始月经。阿片类药物或可卡因阳性与短或长周期无显著相关性。因此，在美沙酮维持期间，月经周期长度开始正常化，月经可能会恢复。美沙酮维持治疗，尽管在绝对意义上干扰月经功能，可能比非法海洛因滥用干扰少。 我们还在进行方法研究，以改进我们对药物使用和剂量适当性的监测。例如，我们正在研究血浆和唾液中美沙酮及其主要代谢物EDDP的游离和蛋白结合对映体浓度之间的关系。我们的合作者已经开发了用于这些目的的新检测方法，现在正在分析来自我们完成的临床试验之一的标本。我们将确定分析物浓度，美沙酮剂量和治疗结果之间的关联。我们在这个项目中的发现可能有助于我们的治疗药物监测，因为我们开始另一个大型临床试验，其中灵活的，个性化的美沙酮每日剂量进行比较，双盲固定高剂量？这一比较从未被系统地进行过。

In this project, we seek to add to the body of literature demonstrating the benefits of methadone maintenance, and to enhance those benefits. We have completed a study to evaluate whether menstrual cycles become more regular during methadone maintenance. While heroin?s menstrual disruption has been demonstrated, there are few published data concerning methadone maintenance and menstrual function. We retrospectively examined data from 191 drug-using women from two clinical trials, lasting 25-29 weeks; each woman was maintained on 70-100 mg of methadone. Start/end dates of each menses were collected. Patterns of menstruation were classified as regular, irregular, transient amenorrhea, persistent amenorrhea, or cycle restart. Repeated-measures regression modeling was used to determine correlates of cycle length and predictors of long cycles (>40 days) and short cycles (<20 days). Bleeding episodes (days from ?start? to ?stop?) were defined as one or more bleeding days, bound by at least two non-bleeding days. Correlates/predictors examined were body mass index, drug use, methadone dose, and race. In the 133 women for whom menstrual patterns could be determined, cycle-length irregularity was common; the patterns seen were: irregular, 62 (46.7%); regular, 37 (27.8%); cycle restart, 16 (12%); persistent amenorrhea, 11 (8.3%); transient amenorrhea, 7 (5.3%). Each additional week on methadone maintenance was associated with decreased risk of long (OR=0.96, p=0.001 and short (OR=0.92, p=0.001) cycles. Of 27 women with secondary amenorrhea pre-study, 16 (59%) restarted menses while maintained on methadone. Positivity for opioids or cocaine was not significantly associated with short or long cycles. Thus, cycle length begins to normalize during methadone maintenance, and menses resumption may occur. Methadone maintenance, despite interfering with menstrual function in an absolute sense, may interfere less than illicit heroin abuse. We are also conducting methodological studies to refine our monitoring of drug use and dose adequacy. For example, we are investigating the relationships among the concentrations of free and protein-bound enantiomers of methadone and its major metabolite EDDP in plasma and saliva. Our collaborators have developed new assays for these purposes and are now analyzing specimens from one of our completed clinical trials. We will determine associations among analyte concentrations, methadone dose, and treatment outcome. Our findings in this project may contribute to our therapeutic drug monitoring as we begin another large clinical trial in which flexible, individualized daily methadone doses are compared double-blind to fixed high doses?a comparison that has never been systematically made.