At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 5 enrolled

Drug / intervention

Guanfacinedrug

Likely dose

Guanfacine 3mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01904526

NCT01904526Phase 2Completed

Compare CT.gov

Pharmacokinetic/Dynamic (PK/PD) Comparison of Guanfacine Extended Release (ER) and Immediate Release (IR) in Smokers

Yale University·interventional·Posted Jul 22, 2013·Updated Mar 6, 2020

In Brief

A Phase 2 clinical trial evaluating Guanfacine for Smoking. Completed, enrolled 5 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsSmoking

CountriesUnited States

CollaboratorsNational Institute on Drug Abuse (NIDA)

Timeline

Phase 2CompletedFinished

2014201520162017201820192020202120222023202420252026

Enrollment StartJul 2013

First PostedJul 2013

Primary CompletionDec 2016

TodayJul 2026

First PostedJul 22, 2013

Enrollment StartJul 1, 2013

Primary CompletionDec 1, 2016

TodayJul 2, 2026

Enrollment to primary: 3.4 yearsPosted 12.9 years ago

Interventions

Guanfacinedrug

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.