CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 48 enrolled
Drug / intervention
Vareniclinedrug
Likely dose
Varenicline 0.5 mgfrom 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/NCT00948155
NCT00948155Phase 4Completed
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Assessment of Smoking Topography and Behaviors During Response to Varenicline

University of Pennsylvania·interventional·Posted Jul 29, 2009·Updated Dec 16, 2014

In Brief

A Phase 4 clinical trial evaluating Varenicline for Nicotine Dependence. Completed, enrolled 48 participants across 1 site.

Detailed Summary

This study will demonstrate the behavioral responses to varenicline, helping to better understand its mechanisms. Hypotheses for the study are to observe decreases in smoking topography and nicotine cigarette choice on varenicline, relative to placebo; and decreases on day 21 relative to day 7 during varenicline treatment. We also propose to examine if extended duration of treatment has clinical significance in decreasing smoking behaviors, thus increasing the efficacy of varenicline.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNicotine Dependence
CountriesUnited States
CollaboratorsPfizer

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 29, 2009
Enrollment StartJan 1, 2009
Primary CompletionNov 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 16.9 years ago

Interventions

Vareniclinedrug

Intervention Drug (Varenicline (Chantix) will be administered in standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21.