CTRI/2011/091/000118
Completed
Phase 2
Efficacy of Varenicline for Smokeless Tobacco Use in India
ational Institute on Drug Abuse R DA0 sites237 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ational Institute on Drug Abuse R DA
- Enrollment
- 237
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •) Males and females over age 18 who have used smokeless tobacco every day for the past year (confirmed with urinary cotinine);
- •b) Residing within 100 km of New Dehli for the next 4 months
- •c) Interested in quitting use of smokeless tobacco.
Exclusion Criteria
- •Participants will be ineligible for the trial if they:
- •1\) are currently enrolled or plan to enroll in another tobacco cessation program in the next 4 months;
- •2\)plan to use other smoking cessation treatments in the next 4 months;
- •3\) smoke cigarettes bidi
- •4\) have current substance abuse (e.g., opioids, cocaine, marijuana) verified by urine drug screen;
- •5\) have current (last 6\-months) alcohol consumption that exceeds 25 standard drinks/week (if past abuse, must be symptom free for ââ?°Â¥ the past 12 months);
- •6\) Current use or discontinuation within last 14 days of:
- •a.smoking cessation medications (bupropion, Chantix, NRT);
- •b.antipsychotics, atypicals, mood\-stabilizers, anti\-depressants (tricyclics, SSRIs, MAOIs), anti\-panic agents, anti\-obsessive agents, anti\-anxiety agents, stimulants;
- •c.Anti\-coagulants;
Outcomes
Primary Outcomes
Not specified
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