TREATMENT OF COCAINE ABUSING WOMEN AT HIGH RISK FOR HIV INFECTION

本研究的目的是评估莫达非尼治疗是否能促进戒断， 可卡因成瘾妇女中与HIV血清转化（HRSB）相关的危险性行为。 预防艾滋病的异性传播可以说是目前面临的最大挑战 医学界。对可卡因上瘾的妇女在以下情况下， 参与HRSB（例如，以性换取可卡因，与多个伴侣发生无保护措施的性行为）以获得 可卡因，在城市社区很容易获得。一种有效的识别和治疗方法 这些妇女应该减少危及她们、她们的性伴侣及其伴侣的伴侣的HRSB。 该项目将利用一个移动的外展货车（MOV），将我们的研究团队放在西 费城的社区可卡因被大量贩运和消费，使我们能够确定 急需教育和戒毒的妇女。在知情同意和全面的 医学/精神病学筛查，合格受试者将接受HIV检测，包括前检测和后检测 旨在提供有关艾滋病毒传播的有效教育的咨询。然后，受试者将 随机接受莫达非尼（300 mg/天）或安慰剂治疗，持续8周，使用研究药物 在MOV中分发和监测，以优化受试者便利性和药物依从性。Modafinil 是一种很有前途的药物，可以在受控条件下阻断可卡因引起的欣快感， 据报道，促进可卡因戒断在一个控制试点研究。心理治疗将包括 电话监测和适应性咨询（TMAC），一种创新和具有成本效益的方法， 为目标人群提供了一种可行的治疗手段。禁欲将是 通过每周两次尿液检测进行客观测量，HRSB将通过风险评估进行测量 电池（RAB）。将在随机化后3个月和6个月安排随访评估，以进一步 评估可卡因戒断率和心率变异性将对受试者进行基因分型，以评估对可卡因的遗传易感性 依赖性和药物遗传学因素与他们的反应莫达非尼。因此，该项目 采用创新的方法来识别，治疗和描述需要有效治疗的目标人群， 旨在促进恢复和预防HRSB的治疗。

The objective of this study is to assess whether modafinil treatment promotes abstinence and reduces high risk sexual behavior associated with HIV seroconversion (HRSB) in women who are addicted to cocaine. Preventing the heterosexual transmission of AIDS is arguably the greatest challenge that currently confronts the medical community. Women addicted to cocaine are at great risk of HIV seroconversion when they engage in HRSB (e.g., trading sex for cocaine, having unprotected sex with multiple partners) to obtain cocaine, which is readily available within urban communities. An effective means of identifying and treating these women should reduce HRSB that jeopardizes them, their sexual partners, and their partners' partners. This project will utilize a mobile outreach van (MOV) that places our research team in the center of West Philadelphia neighborhoods where cocaine is heavily trafficked and consumed, allowing us to identify women in urgent need of education and addiction treatment. After informed consent and a comprehensive medical/psychiatric screening, qualifying subjects will receive HIV testing with pre-test and post-test counseling designed to provide effective education regarding HIV transmission. Subjects will then be randomized to modafinil (300 mg/day) or placebo treatment for a period of 8 weeks with study medications dispensed and monitored in the MOV to optimize subject convenience and medication adherence. Modafinil is a promising agent that blocks cocaine-induced euphoria under controlled conditions, and was recently reported to promote cocaine abstinence in a controlled pilot study. Psychosocial treatment will involve Telephone Monitoring and Adaptive Counseling (TMAC), an innovative and cost-effective approach that provides a feasible means of treatment delivery to the target population. Cocaine abstinence will be measured objectively with twice weekly urine testing and HRSB will be measured with the Risk Assessment Battery (RAB). Follow-up assessments will be scheduled 3 and 6 months after randomization to further assess cocaine abstinence and HRSB. Subjects will be genotyped to assess genetic vulnerability to cocaine dependence and pharmacogenetic factors associated with their response to modafinil. Thus, this project employs innovative means of identifying, treating, and characterizing a target population in need of effective treatment designed to promote recovery and prevent HRSB.