Comparison of effectiveness of Bupropion and Nicotine gum for smokers dependent on Opioids
- Conditions
- Health Condition 1: F172- Nicotine dependence
- Registration Number
- CTRI/2024/05/067468
- Lead Sponsor
- ational Drug Dependent Treatment Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Age 18 to 60 years
Male
Current (last 1 month) user of tobacco by smoking route
Diagnosed with nicotine dependence, current use as per ICD-11 criteria
Currently following up in NDDTC OPD for Opioid agonist maintenance treatment (Buprenorphine-Naloxone) with 80% medication dispensing
Willing to participate in follow up at 4-6 weeks and 12-14 weeks
History of co-morbid psychiatric illnesses (as per clinical interview)
Current (last 1 month)Dependence on drugs other than opioid and nicotine
Current users of smokeless tobacco
Has ever received tobacco cessation intervention (except simple advice from a health care professional) in the past 3 months
Unwilling to give informed consent
Contraindication for Nicotine replacement therapy (accelerated hypertension, post-myocardial infarction period (2 weeks), hypersensitivity to NRT) or Bupropion (Seizure episode, eating disorder)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method i. Biochemically confirmed seven-day point prevalence abstinence at 1- and 3-month follow-up <br/ ><br>ii. Reduction in smoking use as measured by self-reported amount of tobacco use(number of beedi or cigarettes) <br/ ><br>Timepoint: 1 month and 3 months
- Secondary Outcome Measures
Name Time Method i. Continuous abstinence from smoking at 1- and 3-month follow-up (Complete abstinence beginning on the target quit date till the date of assessment) <br/ ><br>ii. Change in the stage of motivation <br/ ><br>Timepoint: 1 month and 3 months