PK/PD Comparison of Guanfacine ER and IR

Yale University

Status and phase

Completed

Phase 2

Conditions

Smoking

Treatments

Drug: Guanfacine

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01904526

1110009133

P50DA033945 (U.S. NIH Grant/Contract)

R01DA035001 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

5 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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