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Efficacy safety and Health-Related Quality of Life (HRQoL) of cytisine in Smoking cessation

A Double-blinded Randomized Controlled Trial.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20180312001
Enrollment
130
Registered
2018-03-12
Start date
2018-05-01
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Smoking Cessation Smoking Cessation Cytisine Safety and Efficacy Cytisine vs Placebo Health&#45

Interventions

Cytisine Film&#45
coated tablets 1.5 mg Dosage regimen: days 1&#45
3&#44
1 tablet every 2 hours (6 tablets/day)
days 4&#45
12&#44
1 tablet every 2.5 hours (5 tablets/day)
days 13&#45
16&#44
1 tablet every 3 hours (4 tablets/day)
days 17&#45
20&#44
1 tablet every 5 hours (3 tablets/day)
days 21&#45
25&#44
1 tablet every 6 hours (2 tablets/day). On first four day smoking should be reduce and stop on the fifth day of drug use.
Experimental Drug
Cytisine

Sponsors

Government Pharmaceutical Organization
Lead Sponsor
Government Pharmaceutical Organization
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Age 18-65 years 2.Smoked more than 10 cigarettes a day less than 1 month 3.Motivated to quit smoking in preparation state according to the Trans-theoretical model. 4.Potentially pregnant female should have birth control 5.Informed consent

Exclusion criteria

Exclusion criteria: 1.Having underlying disease that might be harmed from Cytisine eg. Arrhythmia, Coronary artery disease,Hypertension (Systolic >= 160 mmHg or diastolic >= 100 mmHg), Cancer, Chronic kidney disease (Creatinine clearance = 110 bpm), Acute kidney injury, and Severe hepatitis. 5.Intolerance to adverse drug events.

Design outcomes

Primary

MeasureTime frame
Continuous abstinence rate at 4,12, 24 and 48 weeks Self-reported, Exhaled Carbonmonoxide,Rate and Characteristics of Adverse Events at 4 and 12 weeks Self-reported,Health-related quality of life at 4,12, 24 and 48 weeks EQ-5D-5L THAI and WHOQoL-BREF THAI—

Secondary

MeasureTime frame
Point prevalence abstinence rate at 4, 12, 24 and 48 weeks Self-reported, Exhaled Carbonmonoxide,Compare lung function between cytisine and placebo group at 4, 12, 24 and 48 weeks %PEFR, spirometer,Relapse Rate and Inducing Factor at 24 and 48 weeks Self-reported,Compare quationnaire EQ-5D-5L THAI and WHOQoL-BREF-THAI at 4, 12, 24 and 48 weeks EQ-5D-5L THAI and WHOQoL-BREF THAI—

Contacts

Public ContactPum Phusahat

Department of Clinical Pharmacy Faculty of Pharmaceutical Sciences Khon Kaen University

Poom_phosahut@hotmail.com+66918822366

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Apr 4, 2026