PK/PD Comparison of Guanfacine ER and IR

Completed · Phase 2

Conditions studied: Smoking

In brief

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.

Key facts

Study ID

NCT01904526

Run by

Yale University

People needed

5

Starts

2013-07-01

Expected to finish

2016-12-01

Last updated by the study team

2020-03-06

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Yale Center for Clinical Investigations, Yale University — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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