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PK/PD Comparison of Guanfacine ER and IR

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ClinicalTrials.gov Identifier: NCT01904526
Recruitment Status : Completed
First Posted : July 22, 2013
Results First Posted : April 23, 2018
Last Update Posted : March 6, 2020
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Sherry McKee, Yale University

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.

Condition or disease Intervention/treatment Phase
Smoking Drug: Guanfacine Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Pharmacokinetic/Dynamic (PK/PD) Comparison of Guanfacine Extended Release (ER) and Immediate Release (IR) in Smokers
Study Start Date : July 2013
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Guanfacine
Guanfacine 3 mg/day immediate release followed by Guanfacine 4mg/day extended release followed by Guanfacine 6 mg/day extended release
Drug: Guanfacine
3mg/day IR with 3-week lead-in period. Maintained at steady state to complete lab session. After completion of lab session, 1-week lead-in medication period to 4mg/day ER. Maintained at steady state to complete lab session. After completion of lab session, 1-week lead-in medication period to 6mg/day ER. Maintained at steady state to complete lab session. 5-day taper after lab.
Other Names:
  • Tenex
  • Intuniv




Primary Outcome Measures :
  1. Plasma Trough Levels of Guanfacine [ Time Frame: +24 hours on Lab Session days (Days 22, 49, 58) ]
    Evaluate whether a 4mg/day or 6mg/day dose of extended-release guanfacine produces pharmacokinetic (PK) properties similar to 3mg/day immediate release guanfacine by measuring plasma trough levels of guanfacine for each dose


Secondary Outcome Measures :
  1. Heart Rate [ Time Frame: Last day of titration period 1 (Day 21) to the last day of titration period 3 (Day 57) ]
    Evaluate the safety and tolerability of guanfacine by measuring physiologic reactivity (e.g., heart rate)

  2. Systolic Blood Pressure [ Time Frame: Last day of titration period 1 (Day 21) to the last day of titration period 3 (Day 57) ]
    Evaluate the safety and tolerability of guanfacine by measuring physiologic reactivity (e.g., systolic blood pressure)



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01904526


Locations
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United States, Connecticut
Yale Center for Clinical Investigations, Yale University
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Sherry A McKee, PhD Yale University
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Responsible Party: Sherry McKee, Associate Professor of Psychiatry, Yale University
ClinicalTrials.gov Identifier: NCT01904526    
Other Study ID Numbers: 1110009133
R01DA035001 ( U.S. NIH Grant/Contract )
P50DA033945 ( U.S. NIH Grant/Contract )
First Posted: July 22, 2013    Key Record Dates
Results First Posted: April 23, 2018
Last Update Posted: March 6, 2020
Last Verified: March 2020
Keywords provided by Sherry McKee, Yale University:
Guanfacine
PK/PD
Smokers
Additional relevant MeSH terms:
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Guanfacine
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs