Efficacy of Varenicline for Smokeless Tobacco Use in India

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Pennsylvania
• Collaborator: All India Institute of Medical Sciences, New Delhi
• Treatments: Lobeline; Varenicline

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:

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.