CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 73 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/NCT01308736
NCT01308736N/ACompleted
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Varenicline-Aided Cigarette Reduction in Smokers Not Ready to Quit

Rutgers, The State University of New Jersey·interventional·Posted Mar 4, 2011·Updated Jul 17, 2017

In Brief

A clinical study evaluating Varenicline and Placebo pill for Tobacco Use Disorder. Completed, enrolled 73 participants across 1 site.

Detailed Summary

The investigators will randomize smokers to receive 1) Varenicline + smoking cessation/reduction counseling or 2) Placebo pill + smoking cessation/reduction counseling. Neither the participants nor the research therapists/evaluators will know to which condition (active or placebo pill) the participants have been assigned i.e., a double-blind study). The medication and weekly counseling will occur for 28 days. Participants will complete assessment measures just before the start of treatment (baseline), at the end-of-treatment, at 1-month, 3-month, and at 6-months to determine if there are differences in tobacco use between treatment groups.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTobacco Use Disorder
CountriesUnited States
CollaboratorsPfizer

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 4, 2011
Enrollment StartJan 1, 2011
Primary CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 15.3 years ago

Interventions

Vareniclinedrug

Participants randomized to receive varenicline will follow the Pfizer recommended dosing schedule (0.5 mg QD on days 1-3, 0.5 mg BID on days 4-7, and 1 mg BID thereafter.

Placebo pilldrug

Participants randomized to receive placebo pill will follow the same dosing schedule as those randomized to receive varenicline (1 pill labelled 0.5 mg on days 1-3, pills labelled 0.5 mg BID on days 4-7, and pills labelled 1 mg BID thereafter.