ORCA-1

14 evidence topics · 2 sources

Objective

Dose and schedule selection

“various dosing schedules” (opens the source at this quote in a new tab)

Location and study date

Trial period

Characteristic	Quoted value
First visit date	“20 November 2018”
Completion date	“23 April 2019”

Study design

Phase 2b trial design

“ORCA-1 was a double-blind, randomized, placebo-controlled clinical trial that provided cytisinicline or placebo tablets plus behavioral support for 25 days.” (opens the source at this quote in a new tab)

Eligibility criteria

Cigarette-use eligibility

Characteristic	Quoted value
Baseline daily cigarette threshold	“>10”

Treatment

Cytisinicline dose levels

Characteristic	Quoted value
Lower tablet dose	“1.5 mg”
Higher tablet dose	“3 mg”

Study outcomes

Rationale for using percentage of expected cigarettes smoked as the primary endpoint

Primary smoking-reduction endpoint

“percentage of expected cigarettes smoked” (opens the source at this quote in a new tab)

Secondary week-4 abstinence definition

“CO-verified 7-day point-prevalence abstinence rates at end of treatment” (opens the source at this quote in a new tab)

Statistical analysis description

Number of participants (Planned and analyzed)

Randomized participants

Characteristic	Quoted value
Total randomized	“254”

Description of analysis sets

Analysis principle

“intent-to-treat” (opens the source at this quote in a new tab)

Results

Participant disposition

Medication adherence

“Adherence to study treatment was 98% in the 3mg TID arm” (opens the source at this quote in a new tab)

Baseline characteristics

Baseline age and smoking

Characteristic	Quoted value
Mean age, years	“48.4”
Mean cigarettes per day	“18.2”

Efficacy results

Cytisinicline 3 mg three times daily versus placebo

Outcome	Cytisinicline	Placebo	P value
Four-week abstinence	“50%”	“10%”	“p < 0.001”
Continuous abstinence, weeks 5–8	“30%”	“8%”	“p = 0.005”

Health-related quality of life and patient-reported outcomes

No evidence found.

Safety results

Serious and severe adverse events

“No serious or severe adverse events reported” (opens the source at this quote in a new tab)

Study limitations

Summary

The primary endpoint measured cigarette reduction, not sustained smoking cessation. The table’s four-week abstinence label refers to seven-day point-prevalence abstinence at the end of treatment, not four weeks of continuous abstinence. Continuous abstinence was evaluated separately during weeks 5–8.