Efficacy of Varenicline for Smokeless Tobacco Use in India
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Intervention: Varenicline; Counseling
Intervention description: 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).; 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.
Intervention MeSH terms: Varenicline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 237.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: nicotine smokeless tobacco chewing tobacco varenicline

Summary:

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

Eligibility 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.