NCT00567008已完成2 期
A Double-Blind Placebo-Controlled Pilot Trial of Varenicline (Chantix) for the Treatment of Cocaine 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
- 37
- 试验地点
- 1
- 主要终点
- Evidence of Abstinence From Cocaine as Indicated by Qualitative Urinalysis for Benzoylecgonine.
研究概览
简要总结
The purpose of this study is to determine whether varenicline (Chantix), is effective for the treatment of cocaine dependence.
详细描述
The purpose of study is to determine if Varenicline (Chantix™) promotes cocaine abstinence in cocaine dependent individuals. Varenicline (Chantix™) (2.0 mg/day) or placebo will be administered in a 9-week double-blind trial to patients meeting diagnostic criteria for cocaine dependence.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females, 18 to 65 years old.
- •Meets DSM-IV criteria for Cocaine Dependence, as determined by the Structured Clinical Interview for DSM-IV (SCID).
- •Live within a commutable distance of the Treatment Research Center (TRC) at the Penn/VA Center for Studies of Addiction, University of Pennsylvania. We define this to be a distance within the service area of Septa, within an hour drive, or a distance that both the patient and Principal Investigator (PI) find acceptable.
- •Understands and signs the informed consent.
排除标准
- •Current DSM-IV diagnosis of any psychoactive substance dependence other than cocaine or nicotine dependence, as determined by the SCID.
- •Concomitant treatment with psychotropic medications.
- •Current or prior gambling problems. This will be assessed by the patient's self-report.
- •Patients mandated to treatment based upon a legal decision or as a condition of employment. This will be assessed by the patient's self-report.
- •Current severe psychiatric symptoms, e.g., psychosis, dementia, suicidal or homicidal ideation, mania or depression requiring antidepressant therapy in the opinion of the Principal Investigator (PI)
- •Use of any investigational medication within the past 30 days.
- •History of significant heart disease (an arrhythmia which required medication, Wolff-Parkinson -White Syndrome, angina pectoris, documented history of myocardial infarction, heart failure).
- •History of chest pain associated with cocaine use that has prompted a visit to a physician.
- •Current use of naltrexone, disulfiram, modafinil, stimulants, reserpine, verapamil, theophylline, trimethoprim, cimetidine, haloperidol, benzodiazepines or anticonvulsants.
- •Known hypersensitivity to varenicline.
- •Patients with known AIDS or other serious illnesses that may require hospitalization during the study.
- •Female subjects who are pregnant or lactating, or female subjects of child-bearing potential who are not using acceptable methods of birth control.
- •Acceptable methods of birth control include:
- •barrier (diaphragm or condom) with spermicide
- •intrauterine progesterone contraceptive system
- •levonorgestrel implant
- •medroxyprogesterone acetate contraceptive injection
- •oral contraceptives.
- •tubal ligation.
- •Patients with impaired renal function as indicated by corrected creatinine clearance below 80 ml/min/70 kg as determined by the modified Cockcroft equation (CDC, 1986).
- •Clinical laboratory tests (CBC, blood chemistries, urinalysis) outside normal limits that are clinically unacceptable to the Principal Investigator. EKG 1st degree heart block, sinus tachycardia, left axis deviation, and nonspecific ST or T wave changes are allowed; liver function tests [LFTs] <5 x ULN are acceptable).
研究组 & 干预措施
1
Experimental
Varenicline (Chantix)
干预措施: varenicline (Drug)
2
Placebo Comparator
Placebo
干预措施: placebo (Drug)
结局指标
主要结局
Evidence of Abstinence From Cocaine as Indicated by Qualitative Urinalysis for Benzoylecgonine.
时间窗: 8 weeks
Number of Participants that Tested Negative for Benzoylecgonine in Qualitative Urinalysis Assessment.
次要结局
未报告次要终点
研究者
Jennifer Plebani
Jennifer Plebani, PhD
University of Pennsylvania
研究点 (1)
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