Varenicline for the treatment of cocaine dependence: Phase II

Varenicline 用于治疗可卡因依赖：II 期

基本信息

批准号：
8469851
负责人：
Jennifer Grace Plebani
金额：
$ 57.72万
依托单位：
UNIVERSITY OF PENNSYLVANIA
依托单位国家：
美国
项目类别：
财政年份：
2012
资助国家：
美国
起止时间：
2012-06-01 至 2017-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8469851
关键词：
Abstinence Acquired Immunodeficiency Syndrome Acute Behavior Therapy Behavioral Blood Vessels Bulla Cardiovascular system Chronic Clinical Trials Cocaine Cocaine Dependence Cognitive Therapy Controlled Clinical Trials Coronary Counseling Crack Cocaine Data Double-Blind Method Health Health Care Costs Healthcare Systems Hepatitis C virus Incentives Intervention Measures Minnesota Neurologic Nicotine Outpatients Overdose Participant Patient Self-Report Patients Pennsylvania Pharmaceutical Preparations Phase Phase II Clinical Trials Placebo Control Placebos Plague Procedures Psychological reinforcement Public Health Questionnaires Randomized Recruitment Activity Reinforcement Schedule Relapse Relative (related person)Reporting Research Research Design Risk Sampling Societies Testing Treatment Protocols Treatment outcome Universities Urinalysis Urine Visit cigarette smoking cocaine use contingency management craving design disease transmission effective therapy improved pill pilot trial sex substance abuse treatment varenicline

项目摘要

DESCRIPTION (provided by applicant): Varenicline for the treatment of cocaine dependence: A phase II clinical trial. Cocaine dependence remains a major public health problem, even after over two decades of steady attempts to develop effective behavioral and pharmacological interventions for treating cocaine dependence. Due to the health costs that come directly from cocaine use (e.g., coronary and vascular problems), and those that are more indirect (e.g., spread of AIDS, HCV from exchanging sex for drugs), it is imperative that efforts to develop efficacious treatments continue. To that end, this is a proposed double-blind placebo-controlled clinical trial (n = 200) of varenicline for the treatment of cocaine dependence that utilizes contingency management to promote treatment attendance. In a recently completed pilot trial (n = 37) using the same design, we found that subjects randomized to varenicline showed greater decreases in cocaine use as well as reductions in how valuable or reinforcing they found cocaine (Plebani et al., revision under review). In that study, we used a variable schedule of reinforcement to promote high rates of attendance. That reinforcement led to dramatic increases in attendance rates, and led to far less missing data than usually plagues such trials. Due to these promising results, we now seek to replicate that study in a larger sample in order to have the power to more fully determine the efficacy of varenicline as a treatment for cocaine dependence.

描述（由申请人提供）：可卡因依赖性治疗的Varenicline：II期临床试验。即使经过二十年的稳定尝试来开发有效的行为和药理干预措施，可卡因依赖仍然是一个主要的公共卫生问题。由于直接来自可卡因的健康成本（例如，冠状动脉和血管问题），以及那些更间接的人（例如，艾滋病的传播，hcv，hcv从换毒品），必须继续进行开发有效治疗的努力。为此，这是一项拟议的双盲安慰剂对照临床试验（n = 200），用于对可卡因依赖的治疗，利用应急管理来促进治疗的出勤。在使用相同设计的最近完成的试验试验（n = 37）中，我们发现随机分配给Varenicline的受试者显示可卡因使用的降低较大，并且减少了他们发现可卡因的价值或增强性的降低（Plebani等人，审查的修订版）。在这项研究中，我们使用了可变的加固时间表来促进出勤率高。这种加强导致出勤率的急剧提高，而丢失的数据远不及通常的试验。由于这些有希望的结果，我们现在试图在较大的样本中复制该研究，以便有能力更充分地确定Varenicline作为可卡因依赖性的治疗方法。