A clinical trial to study the effect of a drug, varenicline which may be beneficial for the treatment of subjects who are using tobacco in smokeless form.

Phase 2

Completed

• Conditions: Health Condition 1: F172- Nicotine dependenceHealth Condition 2: null- NICOTINE DEPENDENT PATIENTS USING SMOKELESS TOBACCO

• Registration Number: CTRI/2011/091/000118
• Lead Sponsor: ational Institute on Drug Abuse R DA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2013-10-31
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 237

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 � 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;

d.Daily medication for asthma or diabetes (eligible with physician approval);

7) are pregnant, planning a pregnancy, or lactating;

8) have a history or current diagnosis of psychosis, bipolar disorder, or schizophrenia;

9) have a current diagnosis of depression (if past diagnosis, must be symptom free for � the past 12 months); or generalized anxiety disorder

10) have an allergy to Varenicline

11) ever contemplated or attempted suicide;

12) have serious/unstable disease within the past 6 months (e.g., cancer [but melanoma], heart disease, HIV/AIDS);

13) have a history of epilepsy or seizure disorder;

14) have a history or diagnosis within the last 6 months of abnormal rhythms and/or tachycardia (100 beats/minute);

15) have a history or current diagnosis of COPD; cardiovascular disease (stroke, angina); heart attack in the last 6 months; and/or uncontrolled hypertension (SBP150 or DBP90);

16) have a history of kidney or liver failure;

17) have any medical condition or medication that could compromise safety as determined by a study physician; and

18) cannot provide informed consent or complete the study tasks as determined by the Principal Investigator or study physician.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is 7 day point prevalence smokeless tobacco abstinence biochemically confirmed with urine cotinine(less than 50ng per mL)and Breath CO will rule-out tobacco smoking. <br/ ><br> <br/ ><br>Timepoint: 12 weeks at the end of treatment(EOT)

Secondary Outcome Measures

Name	Time	Method
nicotine withdrawal and craving, negative affect, positive affect, side effects, and biochemically confirmed 7-day point prevalence smokeless tobacco quit rates at 24 and 52 weeksTimepoint: 24 and 52 weeks;Prolonged abstinence from quit day to End of treatment(EOT)Timepoint: 12 weeks - at the end of treatment(EOT)