Health Condition 1: F172- Nicotine dependence
Conditions
Interventions
Intervention1: Varenicline group: Tad Varnicline standard dose shedule as per guideline plus manual guided psychosocial intervention (weekly session for 12 week)
Control Intervention1: Bupropion group
Sponsors
All India Institute of Medical Sciences Patna
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 Timepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. Timepoint: 12 weeks;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. Timepoint: 12 weeks;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. Timepoint: 12 weeks;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. Timepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactDr Sambhu Prasad
All India Institute of Medical Sciences Patna Bihar
Outcome results
None listed