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Efficacy of Varenicline for Smokeless Tobacco Use in India

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ClinicalTrials.gov Identifier: NCT01098305
Recruitment Status : Completed
First Posted : April 2, 2010
Results First Posted : June 9, 2015
Last Update Posted : July 30, 2015
Sponsor:
Collaborator:
All India Institute of Medical Sciences, New Delhi
Information provided by (Responsible Party):
Robert Schnoll, University of Pennsylvania

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

Condition or disease Intervention/treatment Phase
Tobacco Use Disorder Drug: Varenicline Behavioral: Counseling Phase 2

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  (Clinical Trial)
Actual Enrollment : 237 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Varenicline for Smokeless Tobacco Use in India
Study Start Date : April 2011
Primary Completion Date : October 2012
Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Varenicline 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).
Other Name: Chantix
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.
Other Name: Behavioral Counseling
Placebo Comparator: Placebo 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.
Other Name: Behavioral Counseling



Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. 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) ]
    Side Effects



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

    1. smoking cessation medications (bupropion, Varenicline, NRT);
    2. antipsychotics, atypicals, mood-stabilizers, anti-depressants (tricyclics, SSRIs, MAOIs), anti-panic agents, anti-obsessive agents, anti-anxiety agents, stimulants;
    3. Anti-coagulants;
    4. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01098305


Locations
India
All India Institute of Medical Research
New Dehli, India
Sponsors and Collaborators
University of Pennsylvania
All India Institute of Medical Sciences, New Delhi
Investigators
Principal Investigator: Robert A Schnoll, PhD University of Pennsylvania

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Robert Schnoll, Associate Professor, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01098305     History of Changes
Other Study ID Numbers: 811047
First Posted: April 2, 2010    Key Record Dates
Results First Posted: June 9, 2015
Last Update Posted: July 30, 2015
Last Verified: June 2015

Keywords provided by Robert Schnoll, University of Pennsylvania:
nicotine smokeless tobacco chewing tobacco varenicline

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Varenicline
Lobeline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Respiratory System Agents