Human Behavioral Pharmacology Laboratory Study of Varenicline's Impact on Cocaine Reinforcement
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Varenicline's impact on reinforcing effects of cocaine
研究概览
简要总结
Cocaine use, abuse and dependence is a public health problem that is directly responsible for hundreds of billions of dollars in health care expenditures per year. Relapse rates to cocaine use are high, creating a pressing need to develop effective therapies for cocaine dependence. The proposed research will focus on investigating the determinants and consequences of cocaine dependence via measurement of physiological, behavioral and subjective effects of acute doses of cocaine in healthy non-drug dependent human volunteers in the laboratory, and through examination of the effects of pharmacotherapies on the above effects of cocaine. This study will examine cocaine-derived reinforcement under week-long sub-chronic varenicline (Chantix) dosing, and under placebo conditions. The study is a within-subjects crossover design using 24 subjects. Subjects will be screened and consented into the study at the Treatment Research Center (TRC). Study visits where behavioral and physiological outcome data will be obtained will be conducted at the Clinical and Translational Research Center (CTRC) of the Hospital of the University of Pennsylvania. Subjects will be outpatients for this trial, with CTRC sessions scheduled at least one week apart.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Current DSM-IV diagnosis of any psychoactive substance dependence other than nicotine dependence, as determined by the Structured Clinical Interview for the DSM (SCID).
- •Current severe psychiatric symptoms (e.g., psychosis, dementia, suicidal or homicidal ideation, mania or depression requiring anti-depressant therapy) as diagnosed using the SCID, the Hamilton Anxiety Rating Scale (Ham A), and Hamilton Ration Scale for Depression (HAM-D).
- •Individuals scoring > 10 on the Hamilton Rating Scale for Depression (HAM-D).
- •Use of any investigational medication within the past 30 days.
- •Concomitant treatment with psychotropic medications.
- •Concomitant use of any one of the following drugs or classes of drugs:
- •Reserpine
- •Verapamil
- •theophylline,
- •trimethoprim,
- •cimetidine,
- •haloperidol,
- •benzodiazepines, or
- •antiepileptic drugs (AEDs).
- •Patients with a known hypersensitivity to varenicline.
- •Patients with severe concurrent illnesses such as bronchospastic disease, hyperthyroidism, diabetes mellitus.
- •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 method (diaphragm or condom) with spermicide
- •Intrauterine progesterone contraceptive system
- •Levonorgesterel implant
- •Medroxyprogesterone acetate contraceptive injection, or
- •Oral contraceptives.
- •Patients with impaired renal function, as indicated by corrected creatinine clearance below 60 ml/min/70 kg as determined by the modified Cockcroft equation (CDC, 1986).
- •An unacceptable liver panel (liver function tests; LFTs) that may be indicative of hepatic dysfunction.
- •Clinical laboratory tests (e.g., CBC, blood chemistries, urinalysis) outside normal limits.
- •History of significant heart disease or dysfunction (e.g., an arrhythmia which required medication, Wolff Parkinson -White Syndrome, angina pectoris, documented history of myocardial infarction, heart failure).
- •Electrocardiography (EKG) indicative of 1st degree heart block, sinus tachycardia, left-axis deviation, non-specific ST or T-wave changes.
- •History of chest pain associated with cocaine use that prompted a visit to a physician.
研究组 & 干预措施
Varenicline
干预措施: Varenicline (Drug)
Placebo
干预措施: Varenicline (Drug)
结局指标
主要结局
Varenicline's impact on reinforcing effects of cocaine
时间窗: 6 weeks
The primary aim of this study is to examine what impact sub-chronic dosing with varenicline has on the subjective and reinforcing effects of cocaine and on cocaine self-administration in cocaine experienced individuals.
次要结局
未报告次要终点
研究者
Jennifer Plebani
Sponsor-Investigator
University of Pennsylvania