Efficacy of Varenicline for Smokeless Tobacco Use in India

This study has been completed.
Sponsor:
Collaborator:
All India Institute of Medical Sciences, New Delhi
Information provided by (Responsible Party):
Robert Schnoll, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01098305
First received: March 23, 2010
Last updated: August 12, 2014
Last verified: August 2014

March 23, 2010
August 12, 2014
April 2011
October 2012   (final data collection date for primary outcome measure)
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) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01098305 on ClinicalTrials.gov Archive Site
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) ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Efficacy of Varenicline for Smokeless Tobacco Use in India
Efficacy of Varenicline for Smokeless Tobacco Use in India

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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Tobacco Use Disorder
  • 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
  • Active Comparator: Varenicline
    Interventions:
    • Drug: Varenicline
    • Behavioral: Counseling
  • Placebo Comparator: Placebo
    Intervention: Behavioral: Counseling
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
237
October 2013
October 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
India
 
NCT01098305
811047
No
Robert Schnoll, University of Pennsylvania
University of Pennsylvania
All India Institute of Medical Sciences, New Delhi
Principal Investigator: Robert A Schnoll, PhD University of Pennsylvania
University of Pennsylvania
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP