Overview

This trial is active, not recruiting.

Condition smoking
Treatment guanfacine
Phase phase 2
Sponsor Yale University
Collaborator National Institute on Drug Abuse (NIDA)
Start date July 2013
End date July 2017
Trial size 8 participants
Trial identifier NCT01904526, 1110009133, R01DA035001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification pharmacokinetics/dynamics study
Intervention model crossover assignment
Masking open label
Arm
(Experimental)
Guanfacine 3 mg/day immediate release
guanfacine Tenex
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.
(Experimental)
Guanfacine 4mg/day extended release
guanfacine Tenex
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.
(Experimental)
Guanfacine 6 mg/day extended release
guanfacine Tenex
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.

Primary Outcomes

Measure
Evaluate whether a 4mg/day or 6mg/day dose of extended-release guanfacine produces PK properties similar to 3mg/day immediate release guanfacine.
time frame: Lab Sessions (Days 22, 49, 58)

Secondary Outcomes

Measure
Evaluate the safety and tolerability of guanfacine
time frame: Day 1 of titration 1 to the end of followup following the 3rd lab session, which on average will be 2 months.

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title Pharmacokinetic/Dynamic (PK/PD) Comparison of Guanfacine Extended Release (ER) and Immediate Release (IR) in Smokers
Principal investigator Sherry A McKee, PhD
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Yale University.