ORCA-2 (cytisinicline for 12 weeks)
Trial question
What is the role of cytisinicline in adults who smoked cigarettes daily and wanted to quit?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
54.0% female
46.0% male
N = 541
541 patients (294 female, 247 male).
Inclusion criteria: adults who smoked cigarettes daily and wanted to quit.
Key exclusion criteria: previous cytisinicline treatment; known hypersensitivity to cytisinicline; positive urinary drugs of abuse screen determined within 28 days before the first dose of cytisinicline; clinically significant abnormal serum chemistry or hematology values within 28 days of randomization.
Interventions
N=270 cytisinicline (3 mg TID for 12 weeks plus behavioral support).
N=271 placebo (placebo TID for 12 weeks plus behavioral support).
Primary outcome
Proportion of patients achieving a biochemically verified continuous smoking abstinence during weeks 9 to 12
32.6%
7%
32.6 %
24.5 %
16.3 %
8.2 %
0.0 %
Cytisinicline
Placebo
Significant
increase ▲
NNT = 3
Significant increase in the proportion of patients achieving a biochemically verified continuous smoking abstinence during weeks 9 to 12 (32.6% vs. 7%; OR 6.3, 95% CI 3.7 to 11.6).
Secondary outcomes
Significant increase in the proportion of patients achieving a biochemically verified continuous smoking abstinence from weeks 9 to 24 (21.1% vs. 4.8%; OR 5.3, 95% CI 2.8 to 11.1).
Safety outcomes
No significant difference in treatment-emergent adverse event.
Conclusion
In adults who smoked cigarettes daily and wanted to quit, cytisinicline was superior to placebo with respect to the proportion of patients achieving a biochemically verified continuous smoking abstinence during weeks 9 to 12.
Reference
Nancy A Rigotti, Neal L Benowitz, Judith Prochaska et al. Cytisinicline for Smoking Cessation: A Randomized Clinical Trial. JAMA. 2023 Jul 11;330(2):152-160.
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