Efficacy of Varenicline for Smokeless Tobacco Use in India

Phase 2

Completed

Conditions: Tobacco Use Disorder

Interventions: Drug: Varenicline
Behavioral: Counseling

Registration Number: NCT01098305

Lead Sponsor: University of Pennsylvania

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 237

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

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Varenicline	Varenicline	-
Varenicline	Counseling	-
Placebo	Counseling	-

Primary Outcome Measures

Name	Time	Method
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)

Secondary Outcome Measures

Name	Time	Method
Nicotine Withdrawal and Craving, Negative Affect, Positive Affect, and Side Effects.	Ongoing throughout the treatment period (Baseline to the end of treatment, 12 weeks)	Side Effects