- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01098305
Efficacy of Varenicline for Smokeless Tobacco Use in India
July 9, 2015 updated by: Robert Schnoll, University of Pennsylvania
This study, based in India, is testing the efficacy of varenicline to help smokeless tobacco users with cessation efforts.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The prevalence of smokeless tobacco use in the United States is low vs. cigarette smoking, yet rates have remained constant over the past few years.
In contrast, the rate of smokeless tobacco use in India is 20%.
Smokeless tobacco is a carcinogenic and responsible for ~10,000 deaths/year from oral cancer in India.
Unfortunately, there have been remarkably few intervention trials in India for smokeless tobacco users.
To date, no trial has evaluated the new FDA approved medication, varenicline, for smokeless tobacco use.
We will conduct a randomized placebo-controlled trial of varenicline for smokeless tobacco dependence at the National Drug Dependence Treatment Center (NDDTC) at the All India Institute of Medicine (AIIMS) in New Delhi with 237 smokeless tobacco users.
The primary aims of this trial are to: 1) enhance research capacity at the NDDTC (i.e., train AIIMS staff to implement the behavioral counseling protocol with pharmacotherapy, data collection and management procedures); 2) assess the efficacy of varenicline for increasing biochemically confirmed 7-day point prevalence smokeless tobacco quit rates at the end-of treatment; and 3) assess longitudinal patterns of relapse and recovery following treatment with varenicline.
The results of this trial may guide future investments to evaluate the efficacy of varenicline for smokeless tobacco dependence in the US, which is critical since smokeless tobacco use in the US may increase in the coming years and no approved pharmacotherapy for this drug dependence exists in the US or around the globe.
Study Type
Interventional
Enrollment (Actual)
237
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New Dehli, India
- All India Institute of Medical Research
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- males and females
- over age 18
- used smokeless tobacco every day for the past year (confirmed with urinary cotinine)
- residing within 100km of New Dehli for the next 4 months
- interested in quitting use of smokeless tobacco.
Exclusion Criteria:
- currently enrolled or plan to enroll in another tobacco cessation program in the next 4 months
- plan to use other smoking cessation treatments in the next 4 months
- smoke cigarettes
- have current substance abuse (e.g., opioids, cocaine, marijuana) verified by urine drug screen
- have current (last 6-months) alcohol consumption that exceeds 25 standard drinks/week (if past abuse, must be symptom free for ≥ the past 12 months)
Current use or discontinuation within last 14 days of:
- smoking cessation medications (bupropion, Varenicline, NRT);
- antipsychotics, atypicals, mood-stabilizers, anti-depressants (tricyclics, SSRIs, MAOIs), anti-panic agents, anti-obsessive agents, anti-anxiety agents, stimulants;
- Anti-coagulants;
- Daily medication for asthma or diabetes (eligible with physician approval);
- are pregnant, planning a pregnancy, or lactating
- have a history or current diagnosis of psychosis, general anxiety disorder,bipolar disorder, or schizophrenia
- have a current diagnosis of depression (if past diagnosis, must be symptom free for ≥ the past 12 months)
- have an allergy to Varenicline
- ever contemplated or attempted suicide
- have serious/unstable disease within the past 6 months (e.g., cancer [but melanoma], heart disease, HIV/AIDS)
- have a history of epilepsy or seizure disorder
- have a history or diagnosis within the last 6 months of abnormal rhythms and/or tachycardia (>100 beats/minute)
- have a history or current diagnosis of COPD; cardiovascular disease (stroke, angina); heart attack in the last 6 months; and/or uncontrolled hypertension (SBP>150 or DBP>90)16)
- have a history of kidney or liver failure
- have any medical condition or medication that could compromise safety as determined by a study physician
- cannot provide informed consent or complete the study tasks as determined by the Principal Investigator or study physician.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Placebo
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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.
Other Names:
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Active Comparator: Varenicline
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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).
Other Names:
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
7-day Point Prevalence Smokeless Tobacco Abstinence Biochemically Confirmed With Urine Cotinine at the End of 12 Weeks of Treatment.
Time Frame: At the end of treatment (12 weeks)
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At the end of treatment (12 weeks)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nicotine Withdrawal and Craving, Negative Affect, Positive Affect, and Side Effects.
Time Frame: Ongoing throughout the treatment period (Baseline to the end of treatment, 12 weeks)
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Side Effects
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Ongoing throughout the treatment period (Baseline to the end of treatment, 12 weeks)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2011
Primary Completion (Actual)
October 1, 2012
Study Completion (Actual)
October 1, 2013
Study Registration Dates
First Submitted
March 23, 2010
First Submitted That Met QC Criteria
April 1, 2010
First Posted (Estimate)
April 2, 2010
Study Record Updates
Last Update Posted (Estimate)
July 30, 2015
Last Update Submitted That Met QC Criteria
July 9, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 811047
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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