Multisite Controlled Trial of Cocaine Vaccine (2 of 6) Cincinnati Treatment Site

可卡因疫苗多中心对照试验（6 中的 2）辛辛那提治疗中心

• 批准号: 7683035
• 负责人: EUGENE C. SOMOZA
• 金额: $ 30.25万
• 依托单位: UNIVERSITY OF CINCINNATI
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-09-01 至 2013-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7683035
• 关键词: AIDS pharmacotherapy; Abstinence; Acquired Immunodeficiency Syndrome; Acute; Address; Administrative Coordination; Adverse effects; Antibodies; Antibody Formation; Antigen-Antibody Complex; Attenuated; Authorship; Back; Binding; Biological Assay; Blood - brain barrier anatomy; Blood Circulation; Brain; Censuses; Cholera Toxin Protomer B; Clinical Trials; Cocaine; Cocaine Abuse; Cognitive Therapy; Communication; Complement; Connecticut; Coupled; Data; Data Analyses; Dose; Dropout; Drug Addiction; Drug abuse; Drug usage; Educational process of instructing; Electronic Mail; Evaluation; Health; Human; Illicit Drugs; Immunology; Individual; Industry; Injection of therapeutic agent; Joints; Laboratories; Lead; Letters; Manuals; Manufacturer Name; Measures; Medical; Medicine; Mental Depression; Methamphetamine; Monitor; National Institute of Drug Abuse; New York; Nucleus Accumbens; Outcome; Outpatients; Paper; Patient Self-Report; Patients; Pennsylvania; Pharmaceutical Preparations; Pharmacists; Pharmacologic Substance; Pharmacotherapy; Pilot Projects; Placebo Control; Placebos; Population; Procedures; Process; Publications; Qualifying; Randomized; Randomized Clinical Trials; Recombinants; Recruitment Activity; Regimen; Relapse; Reporting; Research; Research Personnel; Risk; Route; Safety; Sample Size; Sampling; Schedule; Site; Smoke; Smoking; Statistical Data Interpretation; Structure; Study Section; Telephone; Testing; Therapeutic; Time; TimeLine; Toxicology; Training; Universities; Update; Urine; Vaccination; Vaccines; Variant; Withdrawal; Work; Writing; addiction; base; benzoylecgonine; cocaine exposure; cocaine use; college; contingency management; control trial; coping; cost; craving; data management; design; drug craving; efficacy testing; electronic data; experience; follow-up; immunogenicity; innovation; intravenous administration; meetings; multi-site trial; novel strategies; novel vaccines; placebo controlled study; prevent; primary outcome; programs; randomized placebo controlled trial; rapid technique; response; skills; success; symposium; treatment response; treatment site; vaccine effectiveness; vaccine efficacy

DESCRIPTION (provided by applicant): This 16 week, six site, placebo-controlled randomized, clinical trial (PC-RCT) among 300 cocaine dependent patients is designed to test the efficacy of a newly developed active vaccine against cocaine (TA-CD). All six sites have substantial NIDA experience in conducting PC-RCT with cocaine pharmacotherapies. The primary objective of this study is to evaluate the efficacy of two different doses of TA-CD (100 or 400 ug) versus placebo to increase the number of cocaine-free days across treatment groups in cocaine-dependent patients. Secondary objectives of this study are: to evaluate safety and tolerability of five injections of TA-CD, to evaluate immunogenicity of TA-CD, to investigate any correlation between change in levels of cocaine use, craving, or subjective effects of cocaine and antibody levels, and finally, to examine predictors of treatment response. Previous work with the TA-CD vaccine has shown both doses (100 and 400 ug) and a regimen of 5 injections over 12 weeks are clinically safe and produce substantial levels of anti-cocaine antibody. During a previous PC-RCT, cocaine abusers with these anti-cocaine antibodies (AB) substantially reduced their smoked cocaine and had a significant reduction in overall cocaine use. That study also showed an expected variation in AB levels was a determinant of therapeutic response (e.g. higher AB levels were associated with a greater reduction in cocaine use). That previous PC-RCT provided effect size data for calculating the sample size of 300 with a potential dropout of up to 30%. In order to enhance retention in this 16-week study, we will use contingency management (CM), which in a pilot study provided outstanding retention of over 80% for a 16 week study. To complete this study within a 3 year period and have reasonable accrual and retention of this difficult population requires participation of six sites. These six extremely well-qualified research groups have comparable and complementary skills that can examine innovative ways to deliver a medical therapy through vaccination. The six sites are: Baylor College of Medicine (BCM), (lead); University of Cincinnati; Johns Hopkins University; University of Pennsylvania; New York University; and Columbia University. All of these collaborators are working with the pharmaceutical manufacturer--Celtic, and NIDA to help with data management and laboratory-processing for quantitative urine toxicology. PUBLIC HEALTH RELEVANCE: New approaches are needed to help treat those addicted to cocaine to successfully keep from relapsing to drug abuse after withdrawal. Vaccines that stimulate strong antibody responses against cocaine will help such individuals by blocking the drug craving that occurs after re-exposure to cocaine in someone who has been abstinent. This research will define ways to make and effectively use such vaccines to stimulate high antibody levels that will have the best chance of success.

描述（由申请人提供）：在300名可卡因依赖性患者中，这16周，六个部位，安慰剂对照的随机试验（PC-RCT）旨在测试新开发的针对可卡因（TA-CD）的新开发的主动疫苗的功效。所有六个地点都在使用可卡因药物疗法进行PC-RCT方面具有丰富的NIDA经验。这项研究的主要目的是评估两种不同剂量的TA-CD（100或400 ug）与安慰剂的疗效，以增加可卡因依赖性患者治疗组的无卡因天数。这项研究的次要目标是：评估TA-CD的五种注射的安全性和耐受性，评估TA-CD的免疫原性，以研究可卡因使用水平的变化，可卡因和抗体水平的主观效应和抗体水平的主观效应，以及最终检查治疗反应的预测因素。 TA-CD疫苗的先前工作既显示了剂量（100 ug）（100 ug），并且在12周内注射5次的治疗方案在临床上是安全的，并且产生了大量抗可卡因抗体。在先前的PC-RCT期间，使用这些抗卡因抗体（AB）的可卡因滥用器大大降低了烟熏可卡因，并大大降低了可卡因的使用。该研究还表明，AB水平的预期差异是治疗反应的决定因素（例如，较高的AB水平与可卡因使用的降低有关）。以前的PC-RCT提供了效应尺寸数据，用于计算300个样本量，潜在辍学率高达30％。为了在这项为期16周的研究中增强保留率，我们将使用应急管理（CM），该研究在一项试点研究中为16周的研究提供了超过80％的出色保留。要在3年内完成这项研究，并具有合理的应计，并且保留了这一困难人群需要参与六个地点。这六个非常合格的研究小组具有可比的和互补的技能，可以检查通过疫苗接种提供医疗疗法的创新方法。六个地点是：贝勒医学院（BCM），（铅）；辛辛那提大学；约翰·霍普金斯大学；宾夕法尼亚大学；纽约大学；和哥伦比亚大学。所有这些合作者都与制药商 - 凯尔特人和NIDA合作，以帮助数据管理和实验室处理，以进行定量尿毒理学。公共卫生相关性：需要新的方法来帮助治疗对可卡因上瘾的人，以便在撤离后成功地避免复发到滥用药物。刺激对可卡因的强抗体反应的疫苗将通过阻止戒酒的人重新暴露可卡因后发生的药物来帮助此类人。这项研究将定义方法并有效使用此类疫苗来刺激最佳机会的高抗体水平。