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Efficacy of Varenicline for Smokeless Tobacco Use in India

NCT01098305 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 237

Last updated 2015-07-30

Study results available
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Summary

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

Conditions

  • Tobacco Use Disorder

Interventions

DRUG

Varenicline

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).

BEHAVIORAL

Counseling

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.

Sponsors & Collaborators

Principal Investigators

  • Robert A Schnoll, PhD · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2012-10-31
Completion
2013-10-31

Countries

  • India

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01098305 on ClinicalTrials.gov