Efficacy of CYTISINE for Smoking Cessation through Downward Titration versus Simplified Three times daily Regimen : Open-label Randomized Clinical Trial
- Conditions
- Smoking CessationSmokerscytisine,Smokers ,
- Registration Number
- TCTR20240711001
- Lead Sponsor
- Thai Health Promotion Foundation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 120
1. Over 18 years of age and not over 65 years of age.
2. Current daily cigarette smokers. There is a need to quit smoking at the preparation/contemplation level according to The Trans theoretical Model.
3. Sign the Informed Consent Form.
4. Smoke more than 10 cigarettes per day.
5. If you are a woman of reproductive age and have a chance of becoming pregnant Must be willing to use birth control before participating in the research project. 6. Have a mobile phone that can set reminders and allow the use of telephone reminder methods. For use in evaluating drug compliance of volunteers
1. Have a congenital disease that may be dangerous from receiving research drugs, such as heart arrhythmia. Coronary artery disease, cancer, chronic kidney disease (creatinine clearance <30 ml/minute), psychiatric disorders such as depression. schizophrenia or patients who also use other types of drugs such as marijuana, amphetamines, etc.
2. Are pregnant or breastfeeding
3. Already being treated with medications to help you quit smoking, including nicotine replacement therapy (NRT), Nortriptyline, Bupropion, Clonidine, and Varenicline.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method continuous smoking abstinence at weeks 4 and 12 verified by self reporting and exhaled carbon monoxide levels at 12 weeks after end of the intervention exhaled carbon monoxide levels (less than7 ppm).
- Secondary Outcome Measures
Name Time Method adverse reactions at 12 weeks after end of the intervention Patient reported outcome using a questionnaire interview