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PK/PD Comparison of Guanfacine ER and IR

Yale University logo

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

5 participants in 1 patient group

Guanfacine
Experimental group
Description:
Guanfacine 3 mg/day immediate release followed by Guanfacine 4mg/day extended release followed by Guanfacine 6 mg/day extended release
Treatment:
Drug: Guanfacine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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