NCT01171183已完成2 期
Clinical Efficacy of Carvedilol for Psychostimulant Dependence
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Urine Toxicology Screens
研究概览
简要总结
This study examines whether carvedilol prolongs abstinence in recently abstinent cocaine dependent participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-45 years old
- •Cocaine dependence, as assessed by the substance abuse section of the Structured Clinical Interview for DSM-IV.
- •At least weekly self-reported cocaine use during a preceding three month period
- •Urine toxicology screen positive for cocaine or cocaine metabolite
- •Women of childbearing age must have a negative pregnancy test, agree to adequate contraception to prevent pregnancy during the study, agree to monthly pregnancy testing and not be nursing
排除标准
- •Suicide attempts within the past 12 months or suicidal ideations or psychotic symptoms in the past 6 months as determined by a study physician.
- •Current opioid, alcohol or sedative physical dependence or amphetamine dependence.
- •Major cardiovascular disorder that contraindicates study participation (e.g., history of myocardial infarction, stroke, congestive heart failure, cardiac arrhythmia, significant hypertension [i.e., >170 SBP or >110 DBP] or an unstable medical condition (e.g., untreated bacterial infection) as determined by the study physician.
- •Asthma or chronic obstructive pulmonary disease.
- •History of schizophrenia, or bipolar type I disorder.
- •Use of medications that would be expected to have major interaction with carvedilol (e.g., rifampin, cimetidine, digoxin, diuretics).
- •Medical contraindication to receiving carvedilol (e.g., diabetes, severe bradycardia, bronchial asthma or other bronchospastic condition, 2nd or 3rd degree AV block, sick sinus rhythm, severe hepatic impairment, documented hypersensitivity to carvedilol).
- •Patients currently taking selective serotonin re-uptake inhibitors, antipsychotics and antidepressants (e.g., amitriptyline and imipramine).
- •Liver function tests (i.e., liver enzymes) greater than three times normal levels.
- •Systolic blood pressure > 170 mmHg or < 90 mmHg, diastolic blood pressure > 110 mmHg or < 60 mmHg, or heart rate of > 110 beats/min or < 55 beats/min. Supine blood pressure of 100/65 mm Hg or lower, a seated blood pressure of 90/60 mm Hg or lower, or an orthostatic change of >20mm Hg systolic or 10 mm Hg diastolic on standing.
- •Participants with estimated glomerular filtration rate < 30 ml/min.
- •Pregnant or nursing female.
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Carvedilol controlled release
Active Comparator
controlled release carvedilol (Coreg CR) at 80 mg/day in once daily dosing
干预措施: controlled release carvedilol (Drug)
结局指标
主要结局
Urine Toxicology Screens
时间窗: based on thrice weekly urine results during the 10-week outpatient phase
Treatment Effectiveness Score, defined by the # of cocaine negative urines during the outpatient phase of the study divided by the total number of urine samples (30) and then multiplied by 100.
次要结局
- Retention(12 weeks)
研究者
研究点 (1)
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