NCT01904526已完成2 期
Pharmacokinetic/Dynamic (PK/PD) Comparison of Guanfacine Extended Release (ER) and Immediate Release (IR) in Smokers
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
- 5
- 试验地点
- 1
- 主要终点
- Plasma Trough Levels of Guanfacine
研究概览
简要总结
Evaluate whether a 4mg/day or 6/mg day dose of extended-release guanfacine produces pharmacokinetic/dynamic (PK/PD) properties similar to 3mg/day immediate release guanfacine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- 是
入选标准
- •Age 18-65
- •Able to read, write and comprehend English
- •Able to take oral medications and willing to adhere to medication regimen
- •Provide evidence of a stable living residence in the last 2 months, have reasonable transportation to the study site, and have no plans to move within the next 3 months or unresolved legal problems.
排除标准
- •Any significant current medical conditions that would contraindicate smoking
- •Current Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) abuse or dependence of other substances, other than nicotine dependence or alcohol abuse
- •Positive test results at intake appointment on urine drug screens for illicit drugs
- •Past 30 day use of psychoactive drugs including anxiolytics and antidepressants
- •Women who are pregnant or nursing
- •Suicidal, homicidal or evidence of current mental illness such as schizophrenia, bipolar disorder or major depression, or anxiety disorders
- •Meeting DSM-IV criteria for current attention deficit hyperactivity disorder (ADHD)
- •Individuals who are currently taking medications known to be effective for smoking cessation or are regular users of other tobacco products in the past 30 days
- •Only one member per household can participate in the study
- •Specific exclusions for administration of guanfacine not already specified include:
- •EKG evidence at baseline screening of any clinically significant conduction abnormalities or arrhythmias
- •Known intolerance for guanfacine or any alpha blocker
- •History of fainting, syncopal attacks
- •Heart failure or myocardial infarction
- •Impaired liver (as indicated by aspartate aminotransferase (AST), alanine aminotransferase (ALT) >3x normal)
- •Renal function (as indicated by estimated creatinine clearance <60cc/min)
- •Treatment with any antihypertensive drug or any alpha-adrenergic blocker
- •Use of any central nervous system depressant (e.g., phenothiazines, barbiturates, benzodiazepines)
- •Use of strong cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ketoconazole) or inducers (e.g., rifampin), or consumption of grapefruit juice
- •Subjects may have not donated blood in the past 8 weeks or have been involved in other investigational studies that involve substantial blood draws or medications unknown to us
研究组 & 干预措施
Guanfacine
Experimental
Guanfacine 3 mg/day immediate release followed by Guanfacine 4mg/day extended release followed by Guanfacine 6 mg/day extended release
干预措施: Guanfacine (Drug)
结局指标
主要结局
Plasma Trough Levels of Guanfacine
时间窗: +24 hours on Lab Session days (Days 22, 49, 58)
Evaluate whether a 4mg/day or 6mg/day dose of extended-release guanfacine produces pharmacokinetic (PK) properties similar to 3mg/day immediate release guanfacine by measuring plasma trough levels of guanfacine for each dose
次要结局
- Heart Rate(Last day of titration period 1 (Day 21) to the last day of titration period 3 (Day 57))
- Systolic Blood Pressure(Last day of titration period 1 (Day 21) to the last day of titration period 3 (Day 57))
研究者
Sherry McKee
Associate Professor of Psychiatry
Yale University
研究点 (1)
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