Elkashef Ahmed, Holmes Tyson H, Bloch Daniel A, Shoptaw Steve, Kampman Kyle, Reid Malcolm S, Somoza Eugene, Ciraulo Domenic, Rotrosen John, Leiderman Deborah, Montgomery Ann, Vocci Frank
Division of Pharmacotherapies and Medical Consequences of Drug Abuse, National Institute on Drug Abuse, National Institutes of Health, Department of Health and Human Services, Bethesda, MD, USA.
Addiction. 2005 Mar;100 Suppl 1:91-101. doi: 10.1111/j.1360-0443.2005.00986.x.
To analyze pooled data from the Cocaine Rapid Evaluation Screening Trial (CREST). Pooling data from these small pilot trials into four major drug classes permitted data exploration for treatment and covariate effects with increased sample size.
Small pilot trials were conducted to screen fifteen medications as prospective treatments for cocaine dependence. Studies included a flexible 2-week to 4-week screening/baseline period followed by an 8-week randomized treatment condition. Participants were randomized equally to one of up to three active medications or placebo.
Five Medications Development Research Units at the five academic centers of University of Cincinnati, New York University, University of Pennsylvania, University of California Los Angeles and Boston University.
The pooled data set consisted of 357 total subjects. Standardized inclusion and exclusion criteria were employed in subject selection to enhance consistency of cocaine-dependent study participants across all sites (see reports on individual trials in this supplement for details). All participants provided at least two urine samples that were positive for cocaine metabolite during a two-week period prior to being randomized.
All subjects in these trials, those randomized to placebo and active medications, received active treatment in the form of evidence-based cognitive behavioral therapy.
Quantitative urine benzoylecgonine (BE), self-report of cocaine use, and total Brief Substance Craving Scale (BSCS) scores were compared between each class of medication and its matched-placebo group.
Regression analysis of pooled data did not identify any statistically significant differences between treatment and matched-placebo for any of the four classes. Exploration of the effects of baseline covariates indicated that gender and African American status were associated significantly with outcome. Female gender was consistently associated with poorer outcomes for medication and placebo groups, while the direction of association between African American status and outcome differed by treatment groups. Retention was also examined: dropout rates may have been somewhat higher for placebo than treatment groups during the early active-treatment period. Classification trees were used to identify characteristics of subjects who were abstinent for at least two weeks during the eight-week trial; only 4.0% of females while 17.9% of males achieved this criterion.
Results presented here may prove useful for planning future clinical trials for therapies targeting cocaine dependence.
分析来自可卡因快速评估筛查试验（CREST）的汇总数据。将这些小型试点试验的数据汇总为四大类药物，从而能够在样本量增加的情况下探索治疗效果和协变量效应。
开展小型试点试验，以筛选15种药物作为可卡因依赖的潜在治疗方法。研究包括一个灵活的2周或4周筛查/基线期，随后是8周的随机治疗期。参与者被等比例随机分配到多达三种活性药物或安慰剂中的一种。
位于辛辛那提大学、纽约大学、宾夕法尼亚大学、加利福尼亚大学洛杉矶分校和波士顿大学这五个学术中心的五个药物研发研究单位。
汇总数据集共有357名受试者。在受试者选择过程中采用了标准化的纳入和排除标准，以提高所有研究地点可卡因依赖研究参与者的一致性（有关详细信息，请参阅本增刊中各单项试验的报告）。所有参与者在随机分组前的两周内至少提供了两份可卡因代谢物呈阳性的尿液样本。
这些试验中的所有受试者，包括随机分配到安慰剂组和活性药物组的受试者，均接受以循证认知行为疗法形式进行的积极治疗。
比较了每类药物与其匹配的安慰剂组之间的尿液中苯甲酰芽子碱（BE）定量、可卡因使用的自我报告以及简短物质渴望量表（BSCS）总分。
汇总数据的回归分析未发现四类药物中任何一类的治疗组与其匹配的安慰剂组之间存在任何具有统计学意义的差异。对基线协变量效应的探索表明，性别和非裔美国人身份与结果显著相关。女性性别一直与药物治疗组和安慰剂组的较差结果相关，而非裔美国人身份与结果之间的关联方向因治疗组而异。还对留存率进行了检查：在早期积极治疗期间，安慰剂组的脱落率可能略高于治疗组。使用分类树来确定在为期8周的试验中至少两周保持戒断的受试者特征；只有4.0%的女性和17.9%的男性达到了这一标准。
本文呈现的结果可能对规划未来针对可卡因依赖的治疗临床试验有用。
