Status:
COMPLETED
PK/PD Comparison of Guanfacine ER and IR
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Smoking
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01904526
Start Date
July 1 2013
End Date
December 1 2016
Last Update
March 6 2020
Active Locations (1)
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1
Yale Center for Clinical Investigations, Yale University
New Haven, Connecticut, United States, 06519