Trial of Cytisine in Adult Smokers
Summary
This placebo-controlled Phase 2b trial is being conducted at sites within the United States (US) to evaluate the effectiveness cytisine dosage (1.5 mg, 3.0 mg) and administration schedule (commercial titration versus simplified 3 times daily \[TID\] schedule) within a 25-day treatment period.
Timeline
- Start
- 2018-11-13
- Primary completion
- 2019-04-23
- Completion
- 2019-04-23
Outcome
Sources disagree · no verdict is set; each source's reading is shown below
registry 1.5 mg Cytisine, Commercial Schedule vs Placebo, Commercial Schedule; p = 0.0002; LS Mean Difference vs. Placebo -20.48 (95% CI -31.141 to -9.821) reads as mixed primary results NCT03709823 ↗
registry 1.5 mg Cytisine, TID Schedule vs Placebo, TID Schedule; p = 0.2708; LS Mean Difference vs. Placebo -5.90 (95% CI -16.463 to 4.660) reads as mixed primary results NCT03709823 ↗
release “The published results indicate that subjects treated with cytisinicline, regardless of dose or schedule, had statistically significantly higher (p<0.001) end of treatment abstinence rates compared to those treated with placebo.” reads as met primary endpoint achievelifesciences.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cytisine | Small molecule | 1.5 mg | — |
| Subject | Cytisine | Small molecule | 3 mg | — |
Indications
No indication recorded.