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Clinical Trials/CTRI/2011/091/000118
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.

Registry
who.int
Start Date
TBD
End Date
October 31, 2013
Last Updated
3 years ago
Study Type
Interventional

Investigators

Sponsor
ational Institute on Drug Abuse R DA

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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