PK/PD Comparison of Guanfacine ER and IR
- Registration Number
- NCT01904526
- Lead Sponsor
- Yale University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5
- Age 18-65
- Able to read, write and comprehend English
- Smoker
- 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.
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Any significant current medical conditions that would contraindicate smoking
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Current Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) abuse or dependence of other substances, other than nicotine dependence or alcohol abuse
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Positive test results at intake appointment on urine drug screens for illicit drugs
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Past 30 day use of psychoactive drugs including anxiolytics and antidepressants
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Women who are pregnant or nursing
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Suicidal, homicidal or evidence of current mental illness such as schizophrenia, bipolar disorder or major depression, or anxiety disorders
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Meeting DSM-IV criteria for current attention deficit hyperactivity disorder (ADHD)
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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
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Only one member per household can participate in the study
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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
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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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Guanfacine Guanfacine Guanfacine 3 mg/day immediate release followed by Guanfacine 4mg/day extended release followed by Guanfacine 6 mg/day extended release
- Primary Outcome Measures
Name Time Method Plasma Trough Levels of Guanfacine +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
- Secondary Outcome Measures
Name Time Method Heart Rate Last day of titration period 1 (Day 21) to the last day of titration period 3 (Day 57) Evaluate the safety and tolerability of guanfacine by measuring physiologic reactivity (e.g., heart rate)
Systolic Blood Pressure Last day of titration period 1 (Day 21) to the last day of titration period 3 (Day 57) Evaluate the safety and tolerability of guanfacine by measuring physiologic reactivity (e.g., systolic blood pressure)
Trial Locations
- Locations (1)
Yale Center for Clinical Investigations, Yale University
🇺🇸New Haven, Connecticut, United States