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.
- Conditions
- Nicotine dependence,
- Registration Number
- CTRI/2011/091/000118
- Lead Sponsor
- National Institute on Drug Abuse R DA
- Brief Summary
This Indo -US study is a randomized, double blind, parallel group clinical trial of the efficacy of varenicline for smokeless tobacco use among 237 individuals recruited by the NDDTC through the AIIMS out-patient department of the Centre for Dental Education and Research (CDER). Eligible and interested individuals will be randomized to placebo or varenicline for 12 weeks, and all will receive behavioral counseling for smokeless tobacco. At weeks -2 to -1, subjects will provide informed consent, be screened for interest and eligibility, including undergoing a medical history and physical exam. They will attend a baseline session (week 0) for assessment, pre-quit counseling, and randomization. Participants will initiate medication at week 0 using the dosing from varenicline smoking cessation trials (Gonzales et al., 2006). Week 1 will be the target quit date and a second counseling session will occur. During the subsequent 11 weeks, participants will receive 4 counseling sessions (15 minutes each at weeks 3, 5, 7, 9). Measures will be completed at Weeks 1, 3, 5, 7, and 9. Assessment of abstinence will occur at week 12 (end of treatment; EOT). Participants who self-report abstinence during the 7 days prior to EOT will be asked to provide a urine sample for biochemical verification. The primary outcome is 7-day point prevalence abstinence at EOT (self-reported abstinence for 7 days prior to the assessment and urinary cotinine of < 50ng/mL). As recommended (Hughes et al. 2003) and as done in previous varenicline trials (Gonzales et al. 2006), secondary outcomes include: continuous abstinence from week 9-12, prolonged abstinence from quit day to EOT (relapse defined as 7 consecutive days of self-reported smokeless tobacco use, after a 2-week grace period defined as smokeless tobacco use for the 1st 14 days in the trial), time to 7-day relapse (no grace period), lapse and recovery events, and withdrawal, craving, affect, and hedonic effects of a lapse. Personnel interacting with subjects will be blind to randomization. All study material will be available in English and Hindi.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 237
) 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.
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. 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 weeks 24 and 52 weeks Prolonged abstinence from quit day to End of treatment(EOT) 12 weeks - at the end of treatment(EOT)
Trial Locations
- Locations (1)
National Drug Dependence Treatment Centre, AII India Institute of Medical Sciences, New Delhi
🇮🇳Delhi, DELHI, India
National Drug Dependence Treatment Centre, AII India Institute of Medical Sciences, New Delhi🇮🇳Delhi, DELHI, IndiaDr Raka JainPrincipal investigator911126593595rakajain2009@gmail.com