PK/PD Comparison of Guanfacine ER and IR

NCT01904526 | Completed Phase 2 Results DMC

• 3 other identifiers: 1110009133R01DA035001P50DA033945
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking

Keywords

Guanfacine; PK/PD; Smokers

Outcome Measures

Primary Outcomes (1)

• Plasma Trough Levels of Guanfacine

  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

  +24 hours on Lab Session days (Days 22, 49, 58)

Secondary Outcomes (2)

• Heart Rate

  Last day of titration period 1 (Day 21) to the last day of titration period 3 (Day 57)

• Systolic Blood Pressure

  Last day of titration period 1 (Day 21) to the last day of titration period 3 (Day 57)

Study Arms (1)

Guanfacine

EXPERIMENTAL

Guanfacine 3 mg/day immediate release followed by Guanfacine 4mg/day extended release followed by Guanfacine 6 mg/day extended release

Drug: Guanfacine

Interventions

Guanfacine DRUG

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.

Also known as: Tenex, Intuniv

Guanfacine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Yale University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Yale Center for Clinical Investigations, Yale University

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Smoking

Interventions

Guanfacine

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids

Results Point of Contact

• Title: Sherry McKee, PhD
• Organization: Yale School of Medicine

sherry.mckee@yale.edu

2037373529

Study Officials

• Sherry A McKee, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Study Record Dates

• First Submitted: July 12, 2013
• First Posted: July 22, 2013
• Study Start: July 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 6, 2020
• Results First Posted: April 23, 2018

Record last verified: 2020-03

Locations

US (1)