TRYPTOPHAN AND BEHAVIOR THERAPY FOR COCAINE ABUSE

描述：（申请人摘要） 对可卡因依赖药物疗法的研究趋于 专注于传统药物，如影响多巴胺或 去甲肾上腺素系统。 很少有临床试验检查了 不太传统的药物制剂，如天然膳食 可能纠正与可卡因相关的体内平衡失衡的化合物 使用. 这是一个测试色氨酸在复发中的功效的建议 色氨酸，一种天然存在的 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著减弱兴奋剂 自我管理，但 没有色氨酸作为预防复发药物的临床研究 可卡因依赖的治疗。 两项同期双盲研究， 将进行安慰剂对照门诊临床试验。 人会 招募滥用可卡因的维持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。 是 重要的是检查色氨酸在两个人群中的功效，因为 人群可能在治疗保留、治疗前 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烟，但它们不是 可能提供必要的动机或技能来弃权。 为此 因此，该项目将研究色氨酸之间的相互作用 治疗和代金券激励行为疗法， 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，将提供最佳条件， 色氨酸的影响。 因此，这些研究将：1）确定是否 色氨酸与安慰剂相比影响可卡因和HIV使用的复发 短期居住后的风险行为，以确保最初的 禁欲; 2）在2x2设计中检查色氨酸与色氨酸之间的相互作用， 治疗和行为激励疗法， 3）鼓励保持无毒品; 3）比较 在两个不同的可卡因滥用者的重要群体中， 同时依赖阿片类药物并参加美沙酮治疗的人 维持治疗和那些谁滥用主要是可卡因， 同时依赖阿片类药物; 4）确定色氨酸与 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)确定与阳性临床试验相关的患者特征 结果; 6）识别与差异性相关的患者特征 对特定治疗或治疗组合的反应。 总体而言，这 该项目将提供有关小说能力的有价值的新信息， 一种安全的天然物质--色氨酸， 可卡因复发的可能性，在有希望的行为背景下， 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.