Efficacy of Varenicline for Smokeless Tobacco Use in India

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.