Efficacy of Varenicline for Smokeless Tobacco Use in India

Tobacco Use Disorder Clinical Trial

Official title:

Efficacy of Varenicline for Smokeless Tobacco Use in India

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01098305
• Other study ID #: 811047
• Status: Completed
• Phase: Phase 2
• First received: March 23, 2010
• Last updated: July 9, 2015
• Start date: April 2011
• Est. completion date: October 2013

Study information

• Verified date: June 2015
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review BoardIndia: Indian Council of Medical Research
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 237
• Est. completion date: October 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tobacco Use Disorder

Intervention

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.

Locations

Country	Name	City	State
India	All India Institute of Medical Research	New Dehli

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	All India Institute of Medical Sciences, New Delhi

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	7-day Point Prevalence Smokeless Tobacco Abstinence Biochemically Confirmed With Urine Cotinine at the End of 12 Weeks of Treatment.		At the end of treatment (12 weeks)	No
Secondary	Nicotine Withdrawal and Craving, Negative Affect, Positive Affect, and Side Effects.	Side Effects	Ongoing throughout the treatment period (Baseline to the end of treatment, 12 weeks)	Yes