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Reducing Cocaine/Heroin Abuse with SR-Amphetamine and Buprenorphine

使用 SR-安非他明和丁丙诺啡减少可卡因/海洛因滥用

基本信息

批准号：
7439053
负责人：
Mark K Greenwald
金额：
$ 32.58万
依托单位：
WAYNE STATE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2006
资助国家：
美国
起止时间：
2006-09-30 至 2010-12-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7439053
关键词：
21 year old Abstinence Address Adherence Adult Agonist Amphetamines Attenuated Behavior Therapy Behavior assessment Behavioral Blood Pressure Buprenorphine Cardiovascular system Child Clinical Clinical Pharmacology Clinical Research Clinical Trials Cocaine Cocaine Abuse Cognitive Combination Medication Complex Crime DSM-IV Dangerous Behavior Data Dependence Dextroamphetamine Disease Dose Double-Blind Method Drug Evaluation Drug Interactions Drug abuse Drug usage Economics Elasticity Environment Equipment Evaluation Goals HIV Heart Rate Heroin Heroin Abuse Heroin Dependence Human Hydromorphone Illicit Drugs Individual Infection Injection of therapeutic agent Inpatients Institutes Intervention Intramuscular Laboratories Laboratory Study Maintenance Manuals Marketing Measures Medical Methadone Methods Minority Modeling Monitor Morbidity - disease rate Narcotics National Institute of Drug Abuse Nose Opioid Outpatients Participant Patient Self-Report Patients Pharmaceutical Preparations Pharmacotherapy Phase I Clinical Trials Physiological Placebo Control Placebos Population Prevention therapy Procedures Productivity Protocols documentation Psychological reinforcement Public Health Publishing Randomized Randomized Clinical Trials Recording of previous events Relapse Relative (related person)Research Research Design Research Personnel Research Support Resources Risk Risk Behaviors SR Amphetamine Safety Sampling Schedule Screening procedure Self Administration Severities Sex Behavior Societies Stratification Substance abuse problem Substance-Related Disorders Tablets Target Populations Testing Therapeutic Effect Time Treatment outcome Urinalysis Urine Withdrawal Withdrawal Symptom Woman addiction base biobehavior cocaine relapse prevention cocaine use cognitive behavior therapy cost craving design disorder later incidence prevention drug abstinence drug abuser drug of abuse experience flexibility human subject human subject protection improved innovation medication compliance member model development multidrug abuse prevent programs respiratory safety testing social stimulant abuse substance abuser transmission process treatment program volunteer voucher

项目摘要

DESCRIPTION (provided by applicant): Cocaine and heroin dependence pose disproportionate public health, social, and economic problems via increased risk of medical and psychiatric morbidities, crime, and poor treatment outcome. Human laboratory studies have not examined choice of cocaine or cocaine/opioid combinations, nor interventions to reduce their use. In cocaine/heroin-dependent patients, a dual agonist-replacement approach for cocaine abuse using sustained release d-amphetamine (SR-AMP) with methadone has been shown safe and effective. However, combining the partial mu-opioid agonist buprenorphine (BLIP) rather than methadone with SR-AMP may have four advantages: (1) it is an alternative medication option that may be equally effective, (2) likely safer, (3) preferred by patients, and (4) more widely available. In this 3-year project, cocaine/heroin dependent volunteers will be studied to address two aims: Aim 1 (SR-AMP blockade of cocaine choice in non-treatment seekers). Study 1 will use a within-subject design to test the hypotheses that, relative to placebo SR-AMP (week 1), escalating-dose maintenance on SR-AMP 15 mg BID (week 2) then 30 mg BID (week 3) with BUP (8 mg/day in weeks 1-3) will: [1a] be safe and well tolerated; [1b] decrease choice of cocaine alone or combined with hydromorphone (HYD), relative to HYD alone and placebo on a choice progressive ratio schedule (4 conditions; randomized crossover, double blind, double dummy); [1c] attenuate subjective (high, liking) and physiological (HR, BP) effects during cocaine sampling before choice opportunities; and [1d] increase demand elasticity for cocaine. Aim 2 (SR-AMP prevention of cocaine relapse in treatment seekers). Study 2 will discharge BUP-maintained, illicit drug-abstinent volunteers from an inpatient unit, using a parallel-group, randomized (with stratification), double blind, placebo-controlled design to test the hypothesis that SR-AMP (likely 30 mg BID, based on Study 1 results) with cognitive behavioral therapy and voucher based reinforcement of protocol adherence will: [2a] prevent relapse to cocaine use during a 4-week outpatient evaluation period); [2b] improve medication adherence (number of days on which SR-AMP/BUP is consumed); [2c] attenuate cocaine withdrawal symptoms; and [2d] reduce number of days engaged in HIV risk behaviors. The innovative aims, rigorous methods and clinical/public health significance of this project (i.e. whether SR-AMP has potential efficacy for reducing cocaine use) is highly concordant with this RFA.

描述（由申请人提供）：可卡因和海洛因依赖通过增加医疗和精神病发病率、犯罪和不良治疗结果的风险，造成不成比例的公共卫生、社会和经济问题。人体实验室研究尚未审查可卡因或可卡因/阿片类药物组合的选择，也没有审查减少其使用的干预措施。在可卡因/海洛因依赖患者中，使用缓释d-苯丙胺（SR-AMP）与美沙酮的可卡因滥用的双重激动剂替代方法已被证明是安全有效的。然而，将部分μ阿片激动剂丁丙诺啡（BLIP）而不是美沙酮与SR-AMP组合可能具有四个优点：（1）它是一种可能同样有效的替代药物选择，（2）可能更安全，（3）患者首选，以及（4）更广泛可用。在这个为期3年的项目中，将对可卡因/海洛因依赖志愿者进行研究，以解决两个目标：目标1（SR-AMP阻断非治疗寻求者的可卡因选择）。研究1将使用受试者内设计来检验以下假设：相对于安慰剂SR-AMP（第1周），SR-AMP 15 mg BID（第2周）递增剂量维持，然后30 mg BID（第3周）与BUP（第1-3周8 mg/天）：[1a]安全且耐受性良好;[1b]在选择渐进比例计划中，相对于单独使用HYD和安慰剂，减少了对可卡因单独使用或与氢吗啡酮联合使用（HYD）的选择（4种条件;随机交叉，双盲，双模拟）; [1c]在选择机会之前的可卡因采样期间减弱主观（高，喜欢）和生理（HR，BP）效应;[1d]增加可卡因的需求弹性。目标2（SR-AMP预防寻求治疗者的可卡因复发）。研究2将使用平行组、随机分组，（分层）、双盲、安慰剂对照设计，以检验SR-AMP（根据研究1结果，可能为30 mg BID）与认知行为治疗和基于代金券的方案依从性强化联合使用将：[2a]在为期4周的门诊评估期间防止可卡因使用复发）; [2b]改善药物依从性（服用SR-AMP/BUP的天数）; [2c]减轻可卡因戒断症状;[2d]减少从事艾滋病毒风险行为的天数。该项目的创新目标、严格的方法和临床/公共卫生意义（即SR-AMP是否具有减少可卡因使用的潜在功效）与该RFA高度一致。