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Efficacy of Varenicline for Smokeless Tobacco Use in India

Primary Purpose

Tobacco Use Disorder

Status
Completed
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
Varenicline
Counseling
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tobacco Use Disorder focused on measuring nicotine smokeless tobacco chewing tobacco varenicline

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • All India Institute of Medical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Varenicline

Placebo

Arm Description

Outcomes

Primary Outcome Measures

7-day Point Prevalence Smokeless Tobacco Abstinence Biochemically Confirmed With Urine Cotinine at the End of 12 Weeks of Treatment.

Secondary Outcome Measures

Nicotine Withdrawal and Craving, Negative Affect, Positive Affect, and Side Effects.
Side Effects

Full Information

First Posted
March 23, 2010
Last Updated
July 9, 2015
Sponsor
University of Pennsylvania
Collaborators
All India Institute of Medical Sciences, New Delhi
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1. Study Identification

Unique Protocol Identification Number
NCT01098305
Brief Title
Efficacy of Varenicline for Smokeless Tobacco Use in India
Official Title
Efficacy of Varenicline for Smokeless Tobacco Use in India
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania
Collaborators
All India Institute of Medical Sciences, New Delhi

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder
Keywords
nicotine smokeless tobacco chewing tobacco varenicline

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
237 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Varenicline
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Varenicline
Other Intervention Name(s)
Chantix
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Counseling
Other Intervention Name(s)
Behavioral Counseling
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Nicotine Withdrawal and Craving, Negative Affect, Positive Affect, and Side Effects.
Description
Side Effects
Time Frame
Ongoing throughout the treatment period (Baseline to the end of treatment, 12 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert A Schnoll, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
All India Institute of Medical Research
City
New Dehli
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
26317176
Citation
Jhanjee S, Jain R, Jain V, Gupta T, Mittal S, Goelz P, Schnoll RA. Evaluating the Effects of Varenicline on Craving, Withdrawal, and Affect in a Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Varenicline for Smokeless Tobacco Dependence in India. J Psychoactive Drugs. 2015 Sep-Oct;47(4):325-30. doi: 10.1080/02791072.2015.1075092. Epub 2015 Aug 28.
Results Reference
derived

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Efficacy of Varenicline for Smokeless Tobacco Use in India

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