DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

PK/PD Comparison of Guanfacine ER and IR

Information source: Yale University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Smoking

Intervention: Guanfacine (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Yale University

Official(s) and/or principal investigator(s):
Sherry A McKee, PhD, Principal Investigator, Affiliation: Yale University


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.

Clinical Details

Official title: Pharmacokinetic/Dynamic (PK/PD) Comparison of Guanfacine Extended Release (ER) and Immediate Release (IR) in Smokers

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome: Evaluate whether a 4mg/day or 6mg/day dose of extended-release guanfacine produces PK properties similar to 3mg/day immediate release guanfacine.

Secondary outcome: Evaluate the safety and tolerability of guanfacine


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


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

Locations and Contacts

Yale Center for Clinical Investigations, Yale University, New Haven, Connecticut 06519, United States
Additional Information

Starting date: July 2013
Last updated: April 13, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017