CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 237 enrolled
Drug / intervention
Varenicline +1 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/NCT01098305
NCT01098305Phase 2Completed
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Efficacy of Varenicline for Smokeless Tobacco Use in India

University of Pennsylvania·interventional·Posted Apr 2, 2010·Updated Jul 30, 2015

In Brief

A Phase 2 clinical trial evaluating Varenicline and Counseling for Tobacco Use Disorder. Completed, enrolled 237 participants across 1 site.

Detailed Summary

This study, based in India, is testing the efficacy of varenicline to help smokeless tobacco users with cessation efforts.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTobacco Use Disorder
CountriesIndia
CollaboratorsAll India Institute of Medical Sciences

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 2, 2010
Enrollment StartApr 1, 2011
Primary CompletionOct 1, 2012
Study CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 16.3 years ago

Interventions

Vareniclinedrug

Participants will be randomized to receive varenicline or placebo for 12 weeks. The dosing regimen consistent with FDA guidelines will be used: Day 1-Day 3 (0.5mg once daily); Day 4-Day 7 (0.5mg twice daily); and Day 8-Day 84 (1.0mg twice daily).

Counselingbehavioral

All participants will be provided with a structured behavioral counseling program, involving 6 counseling sessions by a trained NDDTC counselor. This will be a manual-based intervention and revised as needed for cultural relevance and sensitivity by Dr. Stigler. The intervention is designed to enhance awareness of the harmful effects of smokeless tobacco, assist the person in developing skills to quit and avoid relapse, and instruct the smokeless tobacco user on medication adherence, as recommended by experts in the field.