Skip to content

Efficacy of CYTISINE for Smoking Cessation through Downward Titration versus Simplified Three times daily Regimen : Open-label Randomized Clinical Trial

Efficacy of CYTISINE for Smoking Cessation through Downward Titration versus Simplified Three times daily Regimen : Open-label Randomized Clinical Trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20240711001
Enrollment
120
Registered
2024-07-11
Start date
2024-07-03
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smokers cytisine, Smokers , Smoking Cessation

Interventions

Cytisine 1.5 mg each, Film-coated tablets, take 2 tablets 3 times a day for 25 days. The smoker should gradually Reduce the amount of smoking during the first 4 days of taking the medicine. And stop s
Experimental Drug,Experimental Drug
Simplified TID Regimen,Downward Titration regimen

Sponsors

Thai Health Promotion Foundation
Lead Sponsor
The Pharmacy Council of Thailand.
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
adverse reactions at 12 weeks after end of the intervention Patient reported outcome using a questionnaire interview

Countries

Thailand

Contacts

Public ContactNuttaya Panichdee

Department of Medicine, Kalasin Hospital

Nuttaya.panich@gmail.com0897091875

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026