To understand the Efficacy and safety of Varenicline, Bupropion and Nicotine Replacement Therapy for Smokeless Tobacco Cessation in India: A Randomized Controlled Trial
- Conditions
- Nicotine dependence,
- Registration Number
- CTRI/2025/04/085862
- Lead Sponsor
- All India Institute of Medical Sciences Patna
- Brief Summary
Smokeless tobacco (SLT) use, a form of tobacco consumed without combustion/burning, has become a global health issue with about 350 million users, maximally seen in the South-East Asian Region. Its use is associated with a myriad of adverse effects. Around 40% of the total economic cost because of tobacco use occurs in low- and middle-income countries (LMICs), and 25% is accounted for by Brazil, Russia, India, and China alone. India is the second largest consumer (current use- 48% males, 20% females; 275 million adults), and third largest producer of tobacco in the world. It has one of the highest mortality rates related to tobacco (~0.9 million of the 6 million annual deaths globally). The treatment gap for tobacco use in India is as high as 92%.The behavioral interventions have been found to be efficacious for reducing smokeless tobacco dependence when tested in clinical trials (quit rates in such trials rarely exceed 15%). Clinical trials of nicotine replacement therapies (NRTs) have shown efficacy on short-term cessation. Further, clinical trials testing other NRTs and bupropion have not yielded positive results. In contrast, a large placebo controlled trial in Scandinavia found that varenicline was efficacious for smokeless tobacco dependence , and a pilot trial in the northern India reported preliminary support for an additional large clinical trial evaluation of varenicline for smokeless tobacco users in the India considering the potential lower effect size and lower medication adherence rates in this population.iven that varenicline is relatively more effective for treating tobacco smoking than NRT and bupropion and that varenicline significantly reduces craving to use smokeless tobacco, varenicline may be efficacious for treating smokeless tobacco dependence in India
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 84
Use of smokeless tobacco each day for the past year (confirmed with urinary cotinine assessment greater than or equal to 50 ng/ml) The age over 18 years Residing within 120 KM of Patna.
Current cigarette use which is confirmed with breath carbon monoxide level greater than 10 ppm Current or planned use of tobacco cessation treatment Current use of cocaine, marijuana, or opioids or current consumption of greater than or equal to 25 alcoholic drinks per week Current or recent use of psychiatric, pain, or asthma medications Current pregnancy or lactation History or current diagnosis of psychosis, schizophrenia, bipolar disorder, or suicidality Current diagnosis of depression; diagnosis of cancer, heart disease, or HIV or AIDS in past 6 months History of epilepsy or seizures History or diagnosis within the last 6 months of abnormal heart rhythms and or tachycardia which is greater than 100 beats per min History or current diagnosis of chronic obstructive pulmonary disease, cardiovascular disease, heart attack in the last 6 months, and uncontrolled hypertension in which systolic blood pressure greater than 150 or diastolic blood pressure greater than 90 History of kidney or liver failure.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the efficacy of Varenicline, Bupropion, and Nicotine Replacement Therapy (NRT) in achieving smokeless tobacco cessation among users in India, measured by self-reported and biochemically verified abstinence rates at the end of treatment and during follow-up periods 12 weeks
- Secondary Outcome Measures
Name Time Method To assess the impact of medication adherence rates on the effectiveness of Varenicline, Bupropion, and NRT in facilitating tobacco cessation, identifying adherence as a potential mediator of treatment success. To compare the incidence of side effects and serious adverse events among smokeless tobacco users undergoing treatment with Varenicline, Bupropion, and NRT to assess the safety profiles of these pharmacotherapies. To evaluate the cessation success rates among smokeless tobacco users treated with Varenicline, Bupropion, and NRT, considering both the end of treatment and follow-up periods, to determine the sustainability of cessation. To investigate the effect of Varenicline, as compared to Bupropion and NRT, on reducing cravings for smokeless tobacco and enhancing the likelihood of recovery to abstinence following a lapse, highlighting its potential advantages in managing relapse.
Trial Locations
- Locations (1)
All India Institute of Medical Sciences Patna
🇮🇳Patna, BIHAR, India
All India Institute of Medical Sciences Patna🇮🇳Patna, BIHAR, IndiaDr Sambhu PrasadPrincipal investigator8427016592sambhu3011@gmail.com