PK/PD Comparison of Guanfacine ER and IR
This trial is active, not recruiting.
|Collaborator||National Institute on Drug Abuse (NIDA)|
|Start date||July 2013|
|End date||July 2017|
|Trial size||8 participants|
|Trial identifier||NCT01904526, 1110009133, R01DA035001|
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.
|Endpoint classification||pharmacokinetics/dynamics study|
|Intervention model||crossover assignment|
Evaluate whether a 4mg/day or 6mg/day dose of extended-release guanfacine produces PK properties similar to 3mg/day immediate release guanfacine.
time frame: Lab Sessions (Days 22, 49, 58)
Evaluate the safety and tolerability of guanfacine
time frame: Day 1 of titration 1 to the end of followup following the 3rd lab session, which on average will be 2 months.
Male or female participants from 18 years up to 65 years old.
Inclusion Criteria: - 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. Exclusion Criteria: - 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
|Official title||Pharmacokinetic/Dynamic (PK/PD) Comparison of Guanfacine Extended Release (ER) and Immediate Release (IR) in Smokers|
|Principal investigator||Sherry A McKee, PhD|
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