CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 157 enrolled
Drug / intervention
Varenicline +1 moredrug
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/NCT01509547
NCT01509547Phase 3Completed
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A Randomized Controlled Trial of Varenicline for Adolescent Smoking Cessation

Medical University of South Carolina·interventional·Posted Jan 13, 2012·Updated Jul 1, 2020

In Brief

A Phase 3 clinical trial evaluating Varenicline and placebo for Nicotine Dependence. Completed, enrolled 157 participants across 1 site.

Detailed Summary

This is a placebo-controlled smoking cessation treatment study for adolescents ages 14-21. After assessment and inclusion into the study, participants will be randomized to receive a 12-week double blind course of varenicline or placebo.

Study Details

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

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 13, 2012
Enrollment StartAug 1, 2012
Primary CompletionJan 26, 2018
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 14.5 years ago

Interventions

Vareniclinedrug

participants \>55 kg will take varenicline/placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily thereafter. Participants ≤55 kg will take varenicline/placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily thereafter.

placebodrug

participants \>55 kg will take varenicline/placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily thereafter. Participants ≤55 kg will take varenicline/placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily thereafter.