ORCA-V1

14 evidence topics · 1 source

Objective

Vaping-cessation objective

“abstinence from e-cigarette use” (opens the source at this quote in a new tab)

Location and study date

Trial period

Characteristic	Quoted value
First month	“July 2022”
Last month	“February 2023”

Study design

Blinding and allocation

Characteristic	Quoted value
Blinding	“double-blind”
Allocation	“randomized”

Eligibility criteria

Current cigarette-smoking exclusion

“did not currently smoke cigarettes” (opens the source at this quote in a new tab)

Treatment

Dose schedule

Characteristic	Quoted value
Cytisinicline dose, mg	“3”
Daily dosing frequency	“3”
Treatment duration, weeks	“12”

Study outcomes

Rationale for using continuous e-cigarette abstinence as the primary endpoint

Primary endpoint assessment

Characteristic	Quoted value
Continuous vaping-abstinence interval, weeks	“9-12”

Statistical analysis description

Number of participants (Planned and analyzed)

Randomized participants

Characteristic	Quoted value
Cytisinicline	“107”
Placebo	“53”

Description of analysis sets

Classification of missing outcomes

“nonabstinence” (opens the source at this quote in a new tab)

Results

Participant disposition

Trial completion

Characteristic	Quoted value
Participants completing follow-up	“131”

Baseline characteristics

Baseline age

Characteristic	Quoted value
Mean age, years	“33.6”

Efficacy results

Vaping cessation during weeks 9 to 12

Cytisinicline	Placebo	Effect estimate	P value
“31.8%”	“15.1%”	“odds ratio, 2.64; 95% CI, 1.06-7.10”	“P = .04”

Health-related quality of life and patient-reported outcomes

No evidence found.

Safety results

Adverse-event discontinuations

Characteristic	Quoted value
Participants discontinuing cytisinicline because of an adverse event	“4”

Study limitations

Summary

This study enrolled adults who vaped but did not currently smoke cigarettes. It therefore provides supporting evidence for vaping cessation rather than a direct estimate of smoking-cessation efficacy. The investigators called for a larger trial with longer follow-up.

Need for confirmation

“These results need confirmation in a larger trial with longer follow-up.” (opens the source at this quote in a new tab)