TRYPTOPHAN AND BEHAVIOR THERAPY FOR COCAINE ABUSE

描述：（申请人摘要） 针对可卡因依赖的药物疗法的研究倾向于 专注于传统药物，例如影响多巴胺或 去甲肾上腺素系统。 较少的临床试验检验了其功效 较少的传统药物治疗剂，例如天然饮食 可能纠正与可卡因相关的体内平衡失衡的化合物 使用。 这是一项测试色氨酸在复发中的功效的提案 可卡因依赖的预防模型。色氨酸，一种天然存在的物质 膳食成分，是血清素的代谢前体。 临床前 有证据表明色氨酸显着减弱兴奋剂 自我管理，但有 没有色氨酸作为复发预防剂的临床研究 治疗可卡因依赖。 两项同时双盲， 将进行安慰剂对照的门诊临床试验。 一会 招募滥用可卡因、持续服用美沙酮的阿片类药物依赖患者， 另一个将招募非阿片类药物依赖的可卡因滥用者。 它是 检查色氨酸在两个人群中的功效非常重要，因为 人群在治疗保留、治疗前可能存在差异 特征，以及可能对治疗的反应。 虽然新的药物疗法可能有助于药物滥用者戒毒，但它们并不能 可能提供戒烟所需的动机或技能。 为此 原因，该项目将检查色氨酸之间的相互作用 治疗和先前已采用的优惠券激励行为疗法 对治疗可卡因滥用者非常有效。 预计 行为激励干预将通过促进禁欲和 治疗保留，将为观察提供最佳条件 色氨酸的作用。 因此，这些研究将： 1）确定是否 与安慰剂相比，色氨酸影响可卡因和艾滋病毒的复发 短暂居住后的风险行为可确保初始 禁欲； 2) 在 2x2 设计中检查色氨酸之间的相互作用 治疗和行为激励疗法，提供外部 保持不吸毒的激励措施； 3) 比较效果 对两个不同的重要可卡因滥用者群体进行的治疗， 同时依赖阿片类药物并参加美沙酮治疗的人 维持治疗和主要滥用可卡因但不滥用可卡因的人 同时依赖阿片类药物； 4) 确定色氨酸是否与 安慰剂影响可卡因的效果或自我报告的对可卡因的渴望； 5) 识别与阳性临床相关的患者特征 结果； 6) 识别与差异相关的患者特征 对特定治疗或治疗组合的反应。 总体而言，这 项目将提供有关小说能力的有价值的新信息， 安全的、天然存在的物质——色氨酸——可以减少 在有希望的行为背景下，可卡因复发的可能性 治疗干预。

DESCRIPTION: (Applicant's Abstract) Investigations of pharmacotherapies for cocaine dependence have tended to focus upon traditional medications, such as those effecting dopamine or norepinephrine systems. Fewer clinical trials have examined the efficacy of less traditional pharmacotherapeutic agents such as natural dietary compounds that might correct homeostatic imbalances associated with cocaine use. This is a proposal to test the efficacy of tryptophan in a relapse prevention model for cocaine dependence.Tryptophan, a naturally-occurring dietary constituent, is the metabolic precursor for serotonin. Preclinical evidence demonstrates tryptophan significantly attenuates stimulant self-administration, but there are no clinical investigations of tryptophan as a relapse prevention agent in the treatment of cocaine dependence. Two concurrent double-blind, placebo-controlled outpatient clinical trials will be conducted. One will enroll opiate-dependent patients maintained on methadone who abuse cocaine, and the other will enroll non-opiate dependent cocaine abusers. It is important to examine tryptophan's efficacy in both populations, because the populations are likely to differ on treatment retention, on pretreatment characteristics, and possibly on response to treatment. While novel pharmacotherapies may help drug abusers abstain, they are not likely to provide the motivation or skills necessary to abstain. For this reason, this project will examine the interaction between tryptophan treatment and a voucher incentive behavior therapy which has previously been shown highly effective for treating cocaine abusers. It is anticipated the behavioral incentive intervention will, by promoting abstinence and treatment retention, will provide optimal conditions for observing tryptophan's effects. Thus, these studies will: 1) Determine whether tryptophan compared to placebo influences relapse to use of cocaine and HIV risk behavior following a brief residential stay that ensures initial abstinence; 2) Examine in a 2x2 design the interaction between tryptophan treatment and a behavioral incentive therapy that provides external incentives to remain drug-free; 3) Compare the effectiveness of the treatments in two separate important populations of cocaine abusers, those who are concurrently dependent upon opioids and are enrolled in methadone maintenance treatment and those who abuse primarily cocaine and are not concurrently opioid dependent; 4) Determine whether tryptophan compared to placebo influences effects of cocaine or self-reported craving for cocaine; 5) Identify patient characteristics associated with positive clinical outcome; 6) Identify patient characteristics associated with differential response to specific treatments or treatment combinations. Overall, this project will provide valuable new information about the ability of a novel, safe, and naturally occurring substance--tryptophan--to decrease the likelihood of relapse to cocaine, in the context of a promising behavioral treatment intervention.