Progesterone Treatment for Cocaine-Dependent Women

可卡因依赖女性的黄体酮治疗

基本信息

批准号：
7173222
负责人：
Suzette M Evans
金额：
$ 35.58万
依托单位：
NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC
依托单位国家：
美国
项目类别：
财政年份：
2007
资助国家：
美国
起止时间：
2007-09-01 至 2010-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7173222
关键词：
Abstinence Admission activity Adverse effects Attenuated Behavior Therapy Cardiovascular system Clinic Clinical Clinical Trials Cocaine Cocaine Abuse Cocaine Dependence Cognitive Therapy Crack Cocaine Data Double-Blind Method Drug user End Point Equipment and supply inventories Failure Female HIV Hemorrhage Heroin Incentives Individual Laboratory Finding Laboratory Study Maintenance Medical Numbers Oral Patients Pharmaceutical Preparations Pharmacological Treatment Phase Placebo Control Placebos Progesterone Randomized Rate Recording of previous events Route Safety Score Sedation procedure Self Administration Sexual Partners Smoke Smoking Substance abuse problem Synthetic Progestogens Testing Toxic effect Toxicology Trauma Unsafe Sex Urine Week Woman Women&apos s Group base compliance behavior drug of abuse high risk behavior improved male men named group sex social substance abuser treatment trial voucher

项目摘要

DESCRIPTION (provided by applicant): Cocaine dependence continues to be a major social and medical problem nationwide. Moreover, cocaine abuse is a substantial problem among women, with women making up approximately 30% of cocaine abusers seeking treatment. Women become dependent on cocaine more rapidly than men do, and female drug users are more likely than male drug users to be in treatment for "hard" drugs of abuse, such as cocaine and heroin. The majority (73%) of all cocaine treatment admissions are for smoked cocaine and 42% of individuals admitted for smoking crack cocaine were women. This increase in crack cocaine use, particularly among women, has indirectly been associated with an increase in sexually transmitted HIV. Despite this, no concerted efforts have been made to target a pharmacological treatment for female cocaine abusers. Our recent laboratory studies in non-treatment seeking cocaine abusers have shown that oral micronized progesterone reduces the positive subjective effects of cocaine administration and these effects are more robust in females than in males. Further, oral micronized progesterone actually attenuates cocaine-induced increases in cardiovascular effects indicating that this medication may be protective against cocaine toxicity. Lastly, preliminary data indicate that oral micronized progesterone decreases smoked cocaine self- administration in females. Oral micronized progesterone, as opposed to synthetic progestins, has a high safety profile and can be administered to women for prolonged periods, with the most common side effects being sedation and irregular menstrual bleeding. Taken together, these findings suggest that oral micronized progesterone may have clinical utility in reducing cocaine use in cocaine-dependent women seeking treatment. The objective of this RFA is to support pilot clinical trials of medications for substance abuse, including special populations. As such, we propose to conduct a randomized placebo-controlled treatment trial to evaluate the efficacy of oral micronized progesterone compared to placebo in women dependent on crack cocaine. One of the biggest problems in pharmacological treatment trials with substance abusers is poor compliance and retention. We will use voucher incentives for clinic attendance to enhance retention and we will provide brief compliance enhancement therapy. The results of this pilot treatment trial will provide a preliminary basis on which to decide whether to undertake a large-scale clinical trial that would include a more heterogeneous group of women (i.e., women who primarily use cocaine by other routes other than smoked).

描述（由申请人提供）：可卡因依赖仍然是全国一个主要的社会和医学问题。此外，在女性中，可卡因滥用是一个重大的问题，女性约占可卡因虐待者寻求治疗的30％。女性比男性更快地依赖可卡因，而女性吸毒者比男性吸毒者更有可能因可卡因和海洛因等虐待药物而接受“硬”药物治疗。所有可卡因治疗中的大多数（73％）用于熏制可卡因，42％的吸烟可卡因的人是女性。裂纹可卡因使用的增加，尤其是在女性中，间接与性传播的艾滋病毒的增加有关。尽管如此，尚未采取协同的努力来针对女性可卡因滥用者的药理治疗。我们最近在寻求可卡因滥用者的非治疗方面的实验室研究表明，口服微生物孕酮会降低可卡因给药的积极主观作用，而这些作用在女性中比男性更强大。此外，口服微元化孕酮实际上会减弱可卡因诱导的心血管效应的增加，表明这种药物可能可抵抗可卡因毒性。最后，初步数据表明，口服微生物孕酮会降低女性中熏制的可卡因自我给药。与合成孕激素相反，口服微元化孕酮具有很高的安全性，可以长时间对女性施用，最常见的副作用是镇静和不规则的月经出血。综上所述，这些发现表明，口服微矿化孕酮可能在减少可卡因在可卡因依赖性妇女寻求治疗的情况下具有临床实用性。该RFA的目的是支持药物滥用药物的试验临床试验，包括特殊人群。因此，我们建议进行一项随机安慰剂对照的治疗试验，以评估与安慰剂在依赖裂纹可卡因的妇女中相比，与安慰剂相比。药物滥用者的药理治疗试验中最大的问题之一是依从性和保留性差。我们将使用优惠券激励措施进行诊所出勤，以增强保留率，并提供简短的合规性疗法。这项试验治疗试验的结果将为决定是否进行大规模临床试验提供初步基础，该试验将包括一群更异质的妇女（即主要通过烟熏以外的其他路线使用可卡因的妇女）。