Establishing and Eliminating Cue-drug Associations in Human Cocaine Addiction
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Total number of patient controlled analgesic (PCA) pump activations (responses)
研究概览
简要总结
We will develop a procedure for conditioning cue-cocaine associations in human drug users. Next, we will reactivate that learning and intervene pharmacologically to prevent the reconsolidation of cue-drug memories. We hypothesize that a combined behavioral and pharmacological approach will have significant potential for persistently inhibiting relapse.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 - 50 years
- •voluntary, written, informed consent
- •physically healthy by medical history, physical, neurological, ECG, and laboratory examinations
- •DSM-IV criteria for Cocaine Abuse (305.60) or Cocaine Dependence (304.20)
- •recent street cocaine use in excess of that administered in the current study
- •intravenous and/or smoked (crack/freebase) use
- •positive urine toxicology screen for cocaine
- •for females, non-lactating, no longer of child-bearing potential (or agree to practice effective contraception during the study), and a negative serum pregnancy (-HCG) test
- •able to read English and complete study evaluations.
排除标准
- •Other drug dependence (except nicotine)
- •a primary major DSM-IV psychiatric diagnosis (schizophrenia, bipolar disorder, etc.), unrelated to cocaine
- •a history of significant medical (cardiovascular) or neurological illness (e.g., prior myocardial infarction, current active symptoms of cardiovascular disease / angina, evidence of cocaine-related cardiovascular symptoms, prior arrythmias of clinical significance, and/or need for cardiovascular resuscitation, neurovascular events such as transient ischemic attacks, stroke, and/or seizures)
- •current use of psychotropic and/or potentially psychoactive prescription medication
- •seeking treatment for drug abuse/dependence
- •those having contraindications to beta-blocker administration, including diagnoses of asthma, bronchitis, emphysema, or a history of adverse reactions to beta-blockers (including propranolol), as well as those with bradycardia and/or first-degree or greater heart block by ECG
研究组 & 干预措施
placebo
placebo
干预措施: cocaine hydrochloride (Drug)
placebo
placebo
干预措施: propranolol (Drug)
cocaine hydrochloride
cocaine hydrochloride
干预措施: cocaine hydrochloride (Drug)
cocaine hydrochloride
cocaine hydrochloride
干预措施: propranolol (Drug)
cocaine hydrochloride
cocaine hydrochloride
干预措施: placebo (Drug)
propranolol
propranolol
干预措施: cocaine hydrochloride (Drug)
propranolol
propranolol
干预措施: propranolol (Drug)
结局指标
主要结局
Total number of patient controlled analgesic (PCA) pump activations (responses)
时间窗: 3 days
Data on cocaine self-administration (total number of responses) will be checked for normality prior to analysis using Kolmogorov-Smirnov statistics and normal probability plots. Data that is not normally distributed will be log transformed. If it remains highly skewed after transformation, it will be analyzed using non-parametric approaches (e.g., a non-parametric, ANOVA-Type Statistic). Normally distributed data will be analyzed employing a mixed model design, 3-way ANOVA with co-factors of placebo vs propranolol (between subjects), non-cocaine predicting cues vs. cocaine predicting cues (within subjects) and non-reactivated cocaine cues vs. reactivated cocaine cues (within subjects).
次要结局
未报告次要终点
研究者
Robert Malison
Principal Investigator
Yale University