CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,246 enrolled
Drug / intervention
Varenicline +2 moredrug
Likely dose
Varenicline 0.5mgfrom 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/NCT01314001
NCT01314001Phase 3Completed
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Pharmacogenetics of Nicotine Addiction Treatment (PNAT)

University of Pennsylvania·interventional·Posted Mar 14, 2011·Updated Mar 3, 2016

In Brief

A Phase 3 clinical trial evaluating Varenicline, Placebo, and 1 other intervention for Nicotine Addiction. Completed, enrolled 1,246 participants across 4 sites in 2 countries.

Detailed Summary

The purpose of this research program is to understand how a biomarker called the "nicotine metabolite ratio" (also referred to as NMR) may influence a smoker's ability to quit smoking.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNicotine Addiction
CountriesCanada, United States
CollaboratorsNational Institute on Drug Abuse (NIDA)

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 14, 2011
Enrollment StartDec 1, 2010
Primary CompletionDec 1, 2013
Study CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 15.3 years ago

Interventions

Vareniclinedrug

Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally

Placebodrug

Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally Week 1 - 6: 21mg placebo patch Week 7 - 8: 14mg placebo patch Week 9 - 11: 7mg placebo patch

Transdermal Nicotinedrug

Week 1-6: 21mg nicotine patch Week 7-8: 14mg nicotine patch Week 9-11: 7mg nicotine patch