TREATMENT OF FEMALES WITH COCAINE ABUSE

这两部分提案的目标是确定 一种新的药物，利坦色林，在治疗妇女与 可卡因滥用 与男性相比，女性表现出更快的 可卡因成瘾，在治疗中表现更差。 并且他们都 在药物滥用研究中代表性不足。 Ritanserin是一种选择性5-HT 2-羟色胺拮抗剂， 减少大鼠的可卡因使用，减少酒精摄入量和抑郁症， 人类，并具有良好的安全性。 此外，它似乎有 没有滥用的可能。 研究1将评估利坦色林对可卡因自身代谢的影响。 在抑郁和非抑郁的妇女与可卡因管理 虐待 这项研究是一项为期四周的双盲试验，共有84名抑郁症患者参加， 84名非抑郁受试者随机接受利坦色林或安慰剂治疗 条件 结果将通过尿液药物筛查、药物使用 日记和变化的渴望和抑郁的措施。 研究2将 确定利坦色林对可卡因使用复发的影响， 为期一个月的双盲安慰剂对照试验，100名抑郁症患者和100名 非抑郁的可卡因滥用女性 一个标准化的社会心理学 研究中纳入了强调预防复发的治疗成分 2. 结果指标包括药物筛查尿分析，药物使用日记和 渴望、抑郁和复发量表的变化。 待检验的假设是：（1）利坦色林将降低自体- 在抑郁症和抑郁症患者中， 非抑郁症女性对抑郁症女性的影响更大;（2） 利坦色林会减少对可卡因的渴望;（3）利坦色林会 减少可卡因复吸的频率， （4）抑郁症的症状和体征会减少， 利坦色林组与安慰剂组相比。 这项工作将测试一种新的药物的功效， 利坦色林，用于治疗可卡因滥用。 它还将扩展到 对滥用可卡因的妇女了解有限。

The goal of this two part proposal is to determine the effectiveness of a new pharmacologic agent, ritanserin, in the treatment of women with cocaine abuse. Compared to men, women exhibit a more rapid course of cocaine addiction and do worse in treatment. In addition, they are underrepresented in drug abuse studies. Ritanserin, a selective 5-HT2 serotonin antagonist, has been shown to decrease cocaine use in rats, decrease alcohol intake and depression in humans, and has a good safety profile. Additionally, it appears to have no abuse potential. Study 1 will evaluate the effects of ritanserin on cocaine self- administration in both depressed and non-depressed women with cocaine abuse. This study is a four week, double-blind trial of 84 depressed and 84 non-depressed subjects randomized into ritanserin or placebo conditions. Outcome will be determined by urine drug screens, drug use diaries and changes in craving and depression measures. Study 2 will determine the effect of ritanserin on relapse to cocaine use in a six month, double-blind, placebo-controlled trial of 100 depressed and 100 non-depressed women with cocaine abuse. A standardized psychosocial treatment component emphasizing relapse prevention is included in Study 2. Outcome measures include drug screen urinalysis, drug use diaries and changes on craving, depression and relapse scales. Hypotheses to be tested are: (1) ritanserin will decrease both the self- administration of cocaine and relapse to cocaine in both depressed and non-depressed women with a greater effect in depressed women; (2) ritanserin will decrease craving for cocaine; (3) ritanserin will decrease the frequency of relapses to cocaine and the consequences of relapse; and (4) depressive signs and symptoms will be decreased in ritanserin groups as compared to placebo. This work will test the efficacy of a new pharmacologic agent, ritanserin, in the treatment of cocaine abuse. It will also expand upon the limited knowledge of women with cocaine abuse.